Poprawa zdrowia serca i metabolizmu u osób z ciężką chorobą psychiczną poprzez długoterminowe badanie kliniczne (LAGOM)
Podejście podłużne do generowania pozytywnych wyników zdrowotnych kardiometabolicznych w ciężkich chorobach psychicznych
Choroby kardiometaboliczne są powszechne wśród osób z zaburzeniami psychotycznymi, znacząco przyczyniając się do ich krótszej długości życia, obniżonej jakości życia oraz wpływu ekonomicznego na jednostkę i społeczeństwo. Aby poprawić zdrowie kardiometaboliczne, kluczowe znaczenie mają skuteczne i zindywidualizowane interwencje. Przychodnie leczenia psychoz są idealne do takich interwencji ze względu na regularne wizyty pacjentów i dostępność różnorodnych pracowników służby zdrowia. Badacze opracowali i chcą przetestować kompleksowy program interwencyjny mający na celu poprawę zdrowia kardiometabolicznego, poprawę jakości życia i promowanie zdrowego stylu życia, szczególnie dla osób z zaburzeniami psychotycznymi w przychodniach psychiatrycznych w Göteborgu.
Celem tego badania klinicznego jest włączenie 644 osób z zaburzeniami psychotycznymi z sześciu przychodni na Oddziale Zaburzeń Psychotycznych Szpitala Uniwersyteckiego Sahlgrenska w Göteborgu. Dwie przychodnie będą świadczyć interwencję LAGOM, natomiast pozostałe przychodnie będą pełnić funkcję kontroli, oferując „opiekę na dotychczasowym poziomie”. Grupa interwencyjna otrzyma wielodyscyplinarne wsparcie zintegrowane z rutynowymi procedurami klinicznymi. Interwencja obejmuje regularne kontrole i wykorzystanie narzędzi motywacyjnych, w tym analizatora składu ciała i algorytmu przewidywania ryzyka sercowo-naczyniowego (QRISK3).
Jeżeli interwencja skutecznie poprawi zdrowie kardiometaboliczne, poprawi jakość życia tej wrażliwej grupy i okaże się opłacalna, może służyć jako modelowy program do wdrożenia w regionie Västra Götaland.
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hemen Najar, M.D., Ph.D.
- Numer telefonu: 0046 73 566 15 64
- E-mail: hemen.najar@vgregion.se
Lokalizacje studiów
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Gothenburg, Szwecja, 411 13
- Rekrutacyjny
- Psykosmottagning Centrum
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Kontakt:
- Eva Andreasson
- Numer telefonu: 0046 70 242 67 97
- E-mail: evaandreasson17@gmail.com
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Główny śledczy:
- Eva Andreasson
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Gothenburg, Szwecja, 417 52
- Rekrutacyjny
- Psykosmottagning Hisingen
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Kontakt:
- Christina Hagberg
- Numer telefonu: 0046 73 660 14 18
- E-mail: christina.i.hagberg@vgregion.se
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Główny śledczy:
- Christina Hagberg
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Gothenburg, Szwecja, 421 48
- Rekrutacyjny
- Psykosmottagning Väster
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Kontakt:
- Caroline Holmbom
- Numer telefonu: 0046 76 949 43 08
- E-mail: caroline.e.larsson@vgregion.se
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Główny śledczy:
- Caroline Holmbom
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Gothenburg, Szwecja, 415 05
- Rekrutacyjny
- Psykosmottagning Nordost
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Kontakt:
- Elin Saari-Bladmyr
- Numer telefonu: 0046 70 355 13 57
- E-mail: elin.bladmyr@vgregion.se
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Główny śledczy:
- Elin Saari-Bladmyr
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Gothenburg, Szwecja, 416 72
- Rekrutacyjny
- Psykosmottagning Öster
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Kontakt:
- Lina Klysing
- Numer telefonu: 0046 72 145 83 73
- E-mail: lina.persson@vgregion.se
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Główny śledczy:
- Lina Klysing
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Mölndal, Szwecja, 431 35
- Rekrutacyjny
- Psykosmottagning Mölndal
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Kontakt:
- Erik Wålinder
- Numer telefonu: 0046 76 940 29 76
- E-mail: erik.walinder@vgregion.se
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Główny śledczy:
- Erik Wålinder
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Kryteria włączenia:
- Dorośli w wieku ≥18 lat spełniający kryteria diagnostyczne ICD-10 dla któregokolwiek z zaburzeń ze spektrum schizofrenii (F20-F25 lub F28-F29).
- Posiada możliwość podpisania świadomej zgody.
Kryteria wykluczenia:
- Posiadanie elektrycznego implantu medycznego, takiego jak rozrusznik serca lub inne implanty mechaniczne.
- Kobiety w ciąży.
- Uznane za nieodpowiednie do włączenia według uznania badacza.
- Poprzedni udział w badaniu klinicznym.
- Poddawany leczeniu przymusowemu.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Kliniki kontrolne (standardowa opieka)
Model "zwykłej opieki" w Göteborgu obejmuje coroczne badania kontrolne dla osób z zaburzeniami psychotycznymi. Pacjenci uczestniczą w dwóch 60-minutowych wizytach na badania, takie jak badania krwi, pomiar ciśnienia krwi i kontrola wagi, z wynikami ocenianymi przy użyciu standardowych wskaźników lub algorytmów ryzyka, takich jak SCORE2. Lekarze mogą sugerować skierowania do podstawowej opieki zdrowotnej lub zalecać zmiany w stylu życia, w tym w diecie, aktywności fizycznej lub modyfikacjach w używaniu substancji. Wykryte problemy mogą prowadzić do udzielenia prostych porad lub skierowań do promotorów zdrowia w celu uzyskania wsparcia w rzuceniu palenia, porad żywieniowych lub uczestnictwa w zajęciach grupowych. 36-miesięczne (± 6 miesięcy) badanie kliniczne standaryzuje zbieranie danych w czterech przychodniach ambulatoryjnych bez zmiany opieki. Kwalifikujący się pacjenci podpisują zgodę, z możliwością ponownego badania, jeśli pacjent spełnia kryteria wykluczenia podczas jednego corocznego badania, ale nie podczas następnego. Osoby nieuczestniczące kontynuują regularną opiekę. |
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Eksperymentalny: Kliniki Interwencyjne
Roczne badania kontrolne dla grupy interwencyjnej mają taką samą strukturę dwóch wizyt jak w zwykłej opiece rutynowej, przy czym główna różnica polega na treści wizyt.
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Grupa interwencyjna postępuje według ustrukturyzowanego schematu corocznych badań kontrolnych, koncentrując się na ocenie profilu kardiometabolicznego z uwzględnieniem płci i pochodzenia etnicznego. Ocena ta obejmuje śledzenie zmian parametrów kardiometabolicznych, łącznie z ogólnym ryzykiem kardiometabolicznym przy użyciu skali SCORE2 oraz stwierdzenie, czy spełnione są kryteria zespołu metabolicznego. Nawyki związane ze stylem życia ocenia się na podstawie stanu zdrowia, choroby i korzyści wynikających z zaprzestania niezdrowych zachowań. Sesje edukacyjne uświadamiają uczestnikom i rodzinom związek między zaburzeniami psychotycznymi, wyborami dotyczącymi stylu życia i zdrowiem kardiometabolicznym. Stopniowe zmiany stylu życia są dostosowywane do indywidualnych potrzeb, eliminują stres i wyzwania poznawcze oraz są zgodne z krajowymi wytycznymi zdrowotnymi, obejmującymi spersonalizowane porady i narzędzia motywacyjne. Regularne wizyty kontrolne oceniają postęp, a narzędzia motywacyjne „analizator składu ciała i QRISK3” zwiększają zaangażowanie. Kontakt z zasobami wewnętrznymi i zewnętrznymi opiera się na ocenie i pracy motywacyjnej. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Ramy czasowe: At 12 months from baseline.
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Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe. |
At 12 months from baseline.
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Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Ramy czasowe: At 24 months from baseline.
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Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe. |
At 24 months from baseline.
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Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Ramy czasowe: At 36 months from baseline.
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Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe. |
At 36 months from baseline.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in body mass index
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2). |
At 12 months from baseline.
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Change in body mass index
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2). |
At 24 months from baseline.
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Change in body mass index
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2). |
At 36 months from baseline.
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Change in waist-hip ratio
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR). |
At 12 months from baseline.
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Change in waist-hip ratio
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR). |
At 24 months from baseline.
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Change in waist-hip ratio
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR). |
At 36 months from baseline.
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Change in systolic blood pressure
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg). |
At 12 months from baseline.
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Change in systolic blood pressure
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg). |
At 24 months from baseline.
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Change in systolic blood pressure
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg). |
At 36 months from baseline.
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Change in diastolic blood pressure
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg. |
At 12 months from baseline.
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Change in diastolic blood pressure
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg. |
At 24 months from baseline.
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Change in diastolic blood pressure
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg. |
At 36 months from baseline.
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Change in plasma glucose
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L). |
At 12 months from baseline.
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Change in plasma glucose
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L). |
At 24 months from baseline.
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Change in plasma glucose
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L). |
At 36 months from baseline.
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Change in total cholesterol/HDL-C ratio
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio). |
At 12 months from baseline.
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Change in total cholesterol/HDL-C ratio
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio). |
At 24 months from baseline.
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Change in total cholesterol/HDL-C ratio
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio). |
At 36 months from baseline.
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Change in triacylglycerol/high density lipoprotein-cholesterol ratio
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio). |
At 12 months from baseline.
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Change in triacylglycerol/high density lipoprotein-cholesterol ratio
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio). |
At 24 months from baseline.
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Change in triacylglycerol/high density lipoprotein-cholesterol ratio
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio). |
At 36 months from baseline.
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Change in cardiovascular disease (CVD) events
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events. |
At 12 months from baseline.
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Change in cardiovascular disease (CVD) events
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events. |
At 24 months from baseline.
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Change in cardiovascular disease (CVD) events
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events. |
At 36 months from baseline.
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Change in incident rate of type 2 diabetes mellitus events
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events. |
At 12 months from baseline.
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Change in incident rate of type 2 diabetes mellitus events
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events. |
At 24 months from baseline.
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Change in incident rate of type 2 diabetes mellitus events
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events. |
At 36 months from baseline.
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Change in quality of life
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life)*. *Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). |
At 12 months from baseline.
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Change in quality of life
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life)*. *Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). |
At 24 months from baseline.
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Change in quality of life
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life)*. *Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). |
At 36 months from baseline.
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Change in high-sensitivity C-reactive protein
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L). |
At 12 months from baseline.
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Change in high-sensitivity C-reactive protein
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L). |
At 24 months from baseline.
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Change in high-sensitivity C-reactive protein
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L). |
At 36 months from baseline.
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Change in HbA1c
Ramy czasowe: At 12 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol). |
At 12 months from baseline.
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Change in HbA1c
Ramy czasowe: At 24 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol). |
At 24 months from baseline.
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Change in HbA1c
Ramy czasowe: At 36 months from baseline.
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To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol). |
At 36 months from baseline.
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Descriptive cost analysis
Ramy czasowe: At 12 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. |
At 12 months from baseline.
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Descriptive cost analysis
Ramy czasowe: At 24 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. |
At 24 months from baseline.
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Descriptive cost analysis
Ramy czasowe: At 36 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. |
At 36 months from baseline.
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Change in quality-Adjusted Life Years
Ramy czasowe: At 12 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups. |
At 12 months from baseline.
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Change in quality-Adjusted Life Years
Ramy czasowe: At 24 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups. |
At 24 months from baseline.
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Change in quality-Adjusted Life Years
Ramy czasowe: At 36 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups. |
At 36 months from baseline.
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Incremental cost-effectiveness ratio based on CVD
Ramy czasowe: At 12 months from baseline.
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To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained. |
At 12 months from baseline.
|
|
Incremental cost-effectiveness ratio based on CVD
Ramy czasowe: At 24 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained. |
At 24 months from baseline.
|
|
Incremental cost-effectiveness ratio based on CVD
Ramy czasowe: At 36 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained. |
At 36 months from baseline.
|
|
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
Ramy czasowe: At 12 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. |
At 12 months from baseline.
|
|
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
Ramy czasowe: At 24 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. |
At 24 months from baseline.
|
|
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
Ramy czasowe: At 36 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. |
At 36 months from baseline.
|
|
Incremental cost-effectiveness ratio based on QALYs
Ramy czasowe: At 12 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. |
At 12 months from baseline.
|
|
Incremental cost-effectiveness ratio based on QALYs
Ramy czasowe: At 24 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. |
At 24 months from baseline.
|
|
Incremental cost-effectiveness ratio based on QALYs
Ramy czasowe: At 36 months from baseline.
|
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. |
At 36 months from baseline.
|
|
Change in alcohol consumption
Ramy czasowe: At 12 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12). *The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders. |
At 12 months from baseline.
|
|
Change in alcohol consumption
Ramy czasowe: At 24 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12). *The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders. |
At 24 months from baseline.
|
|
Change in alcohol consumption
Ramy czasowe: At 36 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12). *The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders. |
At 36 months from baseline.
|
|
Change in tobacco smoking
Ramy czasowe: At 12 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use). |
At 12 months from baseline.
|
|
Change in tobacco smoking
Ramy czasowe: At 24 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use). |
At 24 months from baseline.
|
|
Change in tobacco smoking
Ramy czasowe: At 36 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use). |
At 36 months from baseline.
|
|
Change in dietary habits
Ramy czasowe: At 12 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice. |
At 12 months from baseline.
|
|
Change in dietary habits
Ramy czasowe: At 24 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice. |
At 24 months from baseline.
|
|
Change in dietary habits
Ramy czasowe: At 36 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice. |
At 36 months from baseline.
|
|
Change in physical activity
Ramy czasowe: At 12 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time). |
At 12 months from baseline.
|
|
Change in physical activity
Ramy czasowe: At 24 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time). |
At 24 months from baseline.
|
|
Change in physical activity
Ramy czasowe: At 36 months from baseline.
|
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time). |
At 36 months from baseline.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Requirements for achieving a change in targeted lifestyle
Ramy czasowe: At 12 months from baseline.
|
To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
|
At 12 months from baseline.
|
|
Requirements for achieving a change in targeted lifestyle
Ramy czasowe: At 24 months from baseline.
|
To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
|
At 24 months from baseline.
|
|
Requirements for achieving a change in targeted lifestyle
Ramy czasowe: At 36 months from baseline.
|
To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
|
At 36 months from baseline.
|
|
Effect of educational sessions
Ramy czasowe: At 12 months from baseline.
|
To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
|
At 12 months from baseline.
|
|
Effect of educational sessions
Ramy czasowe: At 24 months from baseline.
|
To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
|
At 24 months from baseline.
|
|
Effect of educational sessions
Ramy czasowe: At 36 months from baseline.
|
To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
|
At 36 months from baseline.
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CIV-24-09-049056
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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