Health dialogue intervention versus opportunistic screening in primary care for type 2 diabetes and cardiovascular disease prevention in settings with low socioeconomic status (DETECT): study protocol for a pragmatic cluster-randomized trial.
Humans
Diabetes Mellitus, Type 2
/ diagnosis
Primary Health Care
Cardiovascular Diseases
/ prevention & control
Pragmatic Clinical Trials as Topic
Middle Aged
Mass Screening
/ methods
Cost-Benefit Analysis
Sweden
/ epidemiology
Multicenter Studies as Topic
Female
Time Factors
Risk Reduction Behavior
Male
Social Class
Healthy Lifestyle
Predictive Value of Tests
Risk Assessment
Health Care Costs
Treatment Outcome
Low Socioeconomic Status
Health check
Health promotion
Lifestyle
Prevention
Primary care
Screening
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Oct 2024
12 Oct 2024
Historique:
received:
04
07
2024
accepted:
07
10
2024
medline:
12
10
2024
pubmed:
12
10
2024
entrez:
11
10
2024
Statut:
epublish
Résumé
Meta-analyses of randomized trials suggest that health checks and health promotion interventions targeting behavior change in primary care do not prevent cardiovascular morbidity and mortality in the general population. However, whether such interventions are more effective in high-risk populations, such as people living in low socioeconomic settings, remains unclear, as they have been poorly represented in previous trials. Therefore, we aim to evaluate the effectiveness, cost-effectiveness, and implementation of systematic screening followed by an individually oriented, lifestyle-focused, health dialogue intervention for prevention of type 2 diabetes and cardiovascular disease, as compared to opportunistic screening, in primary care in socioeconomically disadvantaged areas. Using an overall pragmatic approach and a cluster-randomized design with two arms, we aim to enroll 3000 participants aged 50-59 years from 30 primary care centers (PCCs) with an above-average level of Care Need Index in Stockholm Region, Sweden. PCCs will be randomized (1:1) either to a health dialogue intervention, which includes inviting enlisted patients to a systematic screening of risk factors followed by an individually oriented lifestyle-focused health dialogue, or to opportunistic screening, which includes screening patients for a smaller set of risk factors during an appointment at their PCC taking place for other reasons. The main outcome will be change in systolic blood pressure during 6- and 12-month follow-ups. Additional short-term outcomes will be changes in other biological risk factors, health-related quality-of-life, and lifestyle habits, as well as process and implementation outcomes, and unintended side effects. The long-term effect on type 2 diabetes and cardiovascular disease incidence and mortality will be examined using regional and nationwide registers. Changes in systolic blood pressure and other health outcomes will be analyzed using mixed-effect generalized linear modeling and mixed-effect Cox regression to capture variability between and within PCCs. A health economic evaluation will assess resource use and costs in the short- and long-term. This trial of lifestyle-focused health dialogues and opportunistic screening in primary care in socioeconomically disadvantaged areas in the largest region of Sweden has the potential to yield valuable insights that could support evidence-based policymaking. ClinicalTrials.gov (NCT06067178). Prospectively registered September 27, 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Meta-analyses of randomized trials suggest that health checks and health promotion interventions targeting behavior change in primary care do not prevent cardiovascular morbidity and mortality in the general population. However, whether such interventions are more effective in high-risk populations, such as people living in low socioeconomic settings, remains unclear, as they have been poorly represented in previous trials. Therefore, we aim to evaluate the effectiveness, cost-effectiveness, and implementation of systematic screening followed by an individually oriented, lifestyle-focused, health dialogue intervention for prevention of type 2 diabetes and cardiovascular disease, as compared to opportunistic screening, in primary care in socioeconomically disadvantaged areas.
METHODS
METHODS
Using an overall pragmatic approach and a cluster-randomized design with two arms, we aim to enroll 3000 participants aged 50-59 years from 30 primary care centers (PCCs) with an above-average level of Care Need Index in Stockholm Region, Sweden. PCCs will be randomized (1:1) either to a health dialogue intervention, which includes inviting enlisted patients to a systematic screening of risk factors followed by an individually oriented lifestyle-focused health dialogue, or to opportunistic screening, which includes screening patients for a smaller set of risk factors during an appointment at their PCC taking place for other reasons. The main outcome will be change in systolic blood pressure during 6- and 12-month follow-ups. Additional short-term outcomes will be changes in other biological risk factors, health-related quality-of-life, and lifestyle habits, as well as process and implementation outcomes, and unintended side effects. The long-term effect on type 2 diabetes and cardiovascular disease incidence and mortality will be examined using regional and nationwide registers. Changes in systolic blood pressure and other health outcomes will be analyzed using mixed-effect generalized linear modeling and mixed-effect Cox regression to capture variability between and within PCCs. A health economic evaluation will assess resource use and costs in the short- and long-term.
DISCUSSION
CONCLUSIONS
This trial of lifestyle-focused health dialogues and opportunistic screening in primary care in socioeconomically disadvantaged areas in the largest region of Sweden has the potential to yield valuable insights that could support evidence-based policymaking.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov (NCT06067178). Prospectively registered September 27, 2023.
Identifiants
pubmed: 39394167
doi: 10.1186/s13063-024-08533-8
pii: 10.1186/s13063-024-08533-8
doi:
Banques de données
ClinicalTrials.gov
['NCT06067178']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
672Informations de copyright
© 2024. The Author(s).
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