Verbetering van de hart- en stofwisselingsgezondheid bij mensen met ernstige psychische aandoeningen door middel van een langdurig klinisch onderzoek (LAGOM)
Longitudinale benadering om positieve cardiometabolische gezondheidsresultaten te genereren bij ernstige psychische aandoeningen
Cardiometabolische ziekten komen veel voor bij mensen met psychotische stoornissen, wat aanzienlijk bijdraagt aan hun kortere levensduur, verminderde levenskwaliteit en economische impact op individuen en de samenleving. Om de cardiometabolische gezondheid te verbeteren zijn effectieve en geïndividualiseerde interventies cruciaal. Psychosepoliklinieken zijn ideaal voor deze interventies vanwege de regelmatige patiëntbezoeken en de beschikbaarheid van diverse gezondheidswerkers. De onderzoekers hebben een uitgebreid interventieprogramma ontwikkeld en willen dit testen om de cardiometabolische gezondheid te verbeteren, de kwaliteit van leven te verbeteren en een gezonde levensstijl te bevorderen, specifiek voor mensen met psychotische stoornissen in psychiatrische poliklinieken in Göteborg.
Deze klinische proef heeft tot doel 644 personen met psychotische stoornissen te includeren uit zes poliklinieken van de afdeling Psychotische Stoornissen van het Sahlgrenska Universitair Ziekenhuis in Göteborg. Twee poliklinieken zullen de LAGOM-interventie verzorgen, terwijl de andere poliklinieken als controle zullen dienen en ‘care as usual’ zullen bieden. De interventiegroep krijgt multidisciplinaire ondersteuning, geïntegreerd in de routinematige klinische procedures. De interventie omvat regelmatige follow-ups en het gebruik van motiverende hulpmiddelen, waaronder een analyse van de lichaamssamenstelling en een algoritme voor het voorspellen van cardiovasculaire risico's (QRISK3).
Als de interventie de cardiometabolische gezondheid effectief verbetert, de kwaliteit van leven voor deze kwetsbare groep verbetert en kosteneffectief blijkt, kan deze dienen als modelprogramma voor implementatie in de regio Västra Götaland.
Studie Overzicht
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hemen Najar, M.D., Ph.D.
- Telefoonnummer: 0046 73 566 15 64
- E-mail: hemen.najar@vgregion.se
Studie Locaties
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Gothenburg, Zweden, 411 13
- Werving
- Psykosmottagning Centrum
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Contact:
- Eva Andreasson
- Telefoonnummer: 0046 70 242 67 97
- E-mail: evaandreasson17@gmail.com
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Hoofdonderzoeker:
- Eva Andreasson
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Gothenburg, Zweden, 417 52
- Werving
- Psykosmottagning Hisingen
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Contact:
- Christina Hagberg
- Telefoonnummer: 0046 73 660 14 18
- E-mail: christina.i.hagberg@vgregion.se
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Hoofdonderzoeker:
- Christina Hagberg
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Gothenburg, Zweden, 421 48
- Werving
- Psykosmottagning Väster
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Contact:
- Caroline Holmbom
- Telefoonnummer: 0046 76 949 43 08
- E-mail: caroline.e.larsson@vgregion.se
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Hoofdonderzoeker:
- Caroline Holmbom
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Gothenburg, Zweden, 415 05
- Werving
- Psykosmottagning Nordost
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Contact:
- Elin Saari-Bladmyr
- Telefoonnummer: 0046 70 355 13 57
- E-mail: elin.bladmyr@vgregion.se
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Hoofdonderzoeker:
- Elin Saari-Bladmyr
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Gothenburg, Zweden, 416 72
- Werving
- Psykosmottagning Öster
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Contact:
- Lina Klysing
- Telefoonnummer: 0046 72 145 83 73
- E-mail: lina.persson@vgregion.se
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Hoofdonderzoeker:
- Lina Klysing
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Mölndal, Zweden, 431 35
- Werving
- Psykosmottagning Mölndal
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Contact:
- Erik Wålinder
- Telefoonnummer: 0046 76 940 29 76
- E-mail: erik.walinder@vgregion.se
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Hoofdonderzoeker:
- Erik Wålinder
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Volwassenen, ≥18 jaar, die voldoen aan de diagnostische criteria van de ICD-10 voor een van de schizofreniespectrumstoornissen (F20-F25 of F28-F29).
- Heeft de mogelijkheid om geïnformeerde toestemming te ondertekenen.
Uitsluitingscriteria:
- Een elektrisch medisch implantaat hebben, zoals een pacemaker of andere mechanische implantaten.
- Zwangere vrouwen.
- Ongeschikt geacht voor opname naar goeddunken van de onderzoeker.
- Eerdere deelname aan de klinische proef.
- Onder behandeling met verplichte zorg.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Controleklinieken (gebruikelijke zorg)
Het "gebruikelijke zorg"-model in Göteborg omvat jaarlijkse gezondheidscontroles voor personen met psychotische stoornissen. Patiënten bezoeken twee 60-minuten durende afspraken voor onderzoeken zoals bloedonderzoek, bloeddrukmeting en gewichtscontrole, waarbij de resultaten worden beoordeeld aan de hand van standaardrichtlijnen of risico-algoritmen zoals SCORE2. Artsen kunnen verwijzingen naar de eerstelijnszorg voorstellen of leefstijlaanpassingen aanbevelen, waaronder dieet, lichaamsbeweging of aanpassingen in middelengebruik. Geïdentificeerde problemen kunnen aanleiding geven tot eenvoudig advies of doorverwijzingen naar gezondheidsbevorderaars voor ondersteuning bij stoppen met roken, voedingsadvies of groepsactiviteiten. De klinische studie van 36 ± 6 maanden standaardiseert de gegevensverzameling op vier poliklinieken zonder de zorg te veranderen. In aanmerking komende patiënten tekenen een toestemmingsformulier, waarbij herbeoordeling is toegestaan als een patiënt bij één jaarlijkse controle aan de uitsluitingscriteria voldoet maar niet bij de volgende. Niet-deelnemers gaan door met de reguliere zorg. |
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Experimenteel: Interventie Klinieken
De jaarlijkse gezondheidscontroles voor de interventiegroep volgen dezelfde structuur van twee bezoeken als in de gebruikelijke routinezorg, waarbij het primaire verschil de inhoud van de bezoeken is.
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De interventiegroep volgt een gestructureerd stroomschema voor jaarlijkse gezondheidscontroles, waarbij de nadruk ligt op het beoordelen van het cardiometabolische profiel, rekening houdend met geslacht en etniciteit. Deze beoordeling omvat het volgen van veranderingen in cardiometabolische parameters, naast het algehele cardiometabolische risico met behulp van SCORE2 en of aan de criteria voor metabool syndroom wordt voldaan. Leefgewoonten worden geëvalueerd op basis van de gezondheidstoestand, ziekte en de voordelen van het stoppen met ongezond gedrag. Educatiesessies informeren deelnemers en gezinnen over het verband tussen psychotische stoornissen, levensstijlkeuzes en cardiometabolische gezondheid. Geleidelijke veranderingen in levensstijl zijn afgestemd op individuele behoeften, pakken stress en cognitieve uitdagingen aan en volgen nationale gezondheidsrichtlijnen met persoonlijk advies en motiverende hulpmiddelen. Regelmatige follow-ups beoordelen de voortgang, terwijl motiverende hulpmiddelen "lichaamssamenstellingsanalysator en QRISK3" de betrokkenheid vergroten. Het contact met interne en externe bronnen is gebaseerd op de beoordeling en het motiverende werk. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in body mass index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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Incremental cost-effectiveness ratio based on CVD
Tijdsspanne: 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: 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.
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Incremental cost-effectiveness ratio based on CVD
Tijdsspanne: 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: 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.
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Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
Tijdsspanne: 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 type 2 diabetes mellitus cases averted. |
At 12 months from baseline.
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Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
Tijdsspanne: 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: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. |
At 24 months from baseline.
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Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Requirements for achieving a change in targeted lifestyle
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
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- CIV-24-09-049056
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