- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05379504
Zmniejszanie niepełnosprawności związanej z COVID-19 u starszych osób dorosłych zamieszkujących obszary wiejskie przy użyciu inteligentnych technologii
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Missouri
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Columbia, Missouri, Stany Zjednoczone, 65211
- University of Missouri
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Opis
Kryteria przyjęcia:
- Powyżej 65 roku życia, mieszka w hrabstwie wiejskim, ma trudności z co najmniej 1 czynnością samoobsługową lub 2 czynnościami życia codziennego, ma dostęp do internetu, jest w stanie stać z pomocą lub bez pomocy
Kryteria wyłączenia:
- Oczekiwana długość życia poniżej jednego roku, Ciężkie upośledzenie funkcji poznawczych (minimum ocena stanu psychicznego <17), Życie w placówce świadczącej usługi opiekuńcze, Katz ADL 6, Otrzymywanie fizjoterapii w domu, terapii zajęciowej lub pielęgniarskiej, Byli hospitalizowani więcej niż trzy razy w ciągu ostatnich 12 miesięcy Planują zmienić miejsce zamieszkania w ciągu najbliższego roku
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Samozarządzanie
Tryb zmiany zachowania 5A [39] jest ramą dla interwencji samozarządzania.
Pięć „A” zostanie rozwiązanych poprzez integrację interwencji samozarządzania i systemu czujników.
Odbędą się co najmniej cztery sesje interwencyjne z każdym pracownikiem służby zdrowia (OT, RN i SW) dla 12 wizyt na uczestnika.
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Interwencja samozarządzania zostanie przeprowadzona w ciągu roku.
Odbędą się co najmniej cztery sesje interwencyjne z każdym pracownikiem służby zdrowia (OT, RN i SW) dla 12 wizyt na uczestnika.
Zespół (OT, RN i SW) spotka się dwa razy w ciągu pierwszych 2 miesięcy, aby wybrać wiodącego interwencjonistę w oparciu o cele SMART uczestnika i obszary zainteresowania.
Główny interwencjonista przeprowadzi trzy dodatkowe sesje z uczestnikiem i będzie osobą odpowiedzialną za alerty i komunikaty systemu czujników.
Skalowanie realizacji celów [83] zostanie przeprowadzone podczas kwartalnej rozmowy w celu oceny postępów uczestników w realizacji celów SMART.
Środek ten jest administrowany wspólnie z uczestnikiem, zapewnia dalszą odpowiedzialność, daje uczestnikowi możliwość refleksji nad postępami i jest konkretną miarą „sukcesu” interwencji samozarządzania.
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Aktywny komparator: Edukacja zdrowotna
Uczestnik przydzielony losowo do ramienia standardowej edukacji zdrowotnej otrzyma interwencję w miesiącu 1, a następnie w miesiącach 3, 6, 9 i 12.
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Uczestnicy przydzieleni losowo do ramienia standardowej edukacji zdrowotnej otrzymają interwencję w miesiącu 1, a następnie w miesiącach 3, 6, 9 i 12 (co zbiega się z kwartalnymi wywiadami).
Uczestnik użyje tabletu i platformy telezdrowia, aby przeprowadzić wywiad i sesję edukacyjną z pracownikami naukowymi.
Treść tych sesji będzie koncentrować się na pomaganiu uczestnikowi (oraz członkowi rodziny/opiekunowi w stosownych przypadkach) w zrozumieniu danych dotyczących ich zdrowia, pomaganiu im we wszelkich kwestiach technologicznych oraz zapewnianiu uczestnikowi edukacji na temat jego stanu(ów) i wszelkich wymaganych zasobów.
Personel badawczy zapewni również dodatkową edukację zdrowotną w przypadku zmiany warunków lub nowych diagnoz po wizycie zewnętrznego usługodawcy.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Katz ADL Index
Ramy czasowe: 1 year
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The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, assesses functional status as a measurement of the client's ability to perform activities of daily living independently.
The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding.
Clients are scored yes/no for independence in each of the six functions.
A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
This scale ranges from 0 to 6.
This measure is the calculated change in score from baseline to post-intervention.
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1 year
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Change in PROMIS-43
Ramy czasowe: 1 year
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PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS-43 is a collection of 6-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. Each short form is scored as a T-score, with a score of 50 being average. This scale is 0 to 100. Higher scores indicate more (anxiety, depression, etc) and lower scores indicate less. This measure is the change in the T-score from baseline to post-intervention. A positive change in T-score is different for each sub-domain. Each will be indicated below in the row title. |
1 year
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Hospital Anxiety and Depression Scale
Ramy czasowe: 1 year
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The Hospital Anxiety and Depression Scale is a two dimension scale developed to identify depression and anxiety.
There are 14 items.
The respondent rates each item on a 4 point scale ranging from 0 (absence) to 3 (extreme presence).
Some questions are inversely scored.
This outcome was assessed at baseline and post-intervention.
This measure is the change in score on the scale.
The overall range of scores is 0 to 42.
Anxiety and depression domains are reported separately below.
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1 year
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Change in Canadian Occupational Performance Measure
Ramy czasowe: 1 year
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The COPM is administered by an occupational therapy practitioner.
The participant ranks their five most important occupations that they currently have difficulty with.
Then they rate their current performance and satisfaction with that performance on a scale of 1-10.
The score on those five occupations are averaged to get a score of self-rated occupational performance and self-rated satisfaction with performance.
The scores on both scales can range from 0 to 10.
This measure is the change from baseline to post-intervention on both scores, reported separately below.
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1 year
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Change in Patient Activation Measure
Ramy czasowe: 1 year
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The Patient Activation Measure® is a 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare.
The participants rates how much they agree or disagree (1-4 scale) with 13 statements.
Using a licensed tool, a score ranging 0-100 is calculated.
This measure is the change in that score from baseline to post-intervention.
A positive change score means improvement.
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1 year
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Rachel M Proffitt, OTD, University of Missouri-Columbia
Publikacje i pomocne linki
Publikacje ogólne
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Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2043542
- 1R01AG072935-01A1 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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