No registrations found.
ID
Source
Brief title
Health condition
Cardiometabolic disease, prevention, screening, non-participation, primary care, effectiveness, economic evaluation.
Cardiometabole ziekten, preventie, screening, non-participatie, eerstelijns gezondheidszorg, effectiviteit, economische evaluatie.
Sponsors and support
- University Medical Center Utrecht, Julius Center,
- VU University Medical Center, EMGO Institute for health and care research, Amsterdam
- Dutch Diabetes Research Foundation, in collaboration with: Dutch Heart Foundation, and Dutch Kidney Foundation (LekkerLangLeven)
- Healthcare Insurance Innovation Fund (Innovatiefonds Zorgverzekeraars)
Intervention
Outcome measures
Primary outcome
1. The number of newly detected patients with a CMD in one year follow-up.
2. Change in individual risk factor (smoking, physical inactivity, obesity, unhealthy diet, blood pressure and cholesterol levels) for CMD between baseline and one year follow-up.
3. The expected number of newly detected patients with CMD and mortality after 5, 10, 20 years and lifetime.
4. Costs-effectiveness of PPA CMR
5. Non-participation and compliance in different stages of PPA CMR.
Secondary outcome
1. Difference in primary outcome 5 after implementation of different response-enhancing strategies.
2. Change in willingness to change lifestyle between baseline and one year follow-up.
3. Change in health status between baseline and one year follow up
Background summary
The increasing prevalence of cardiometabolic disease (CMD) asks for an effective program for early detection and management of individuals at risk. In the INTEGRATE study we evaluate the effectiveness and cost-effectiveness of the integrated prevention program ‘Personalized Prevention Approach for CardioMetabolic Risk’ (PPA CMR). In addition, determinants for participation and compliance are established. The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group. We will invite all listed patients without CMD aged 45-70 years of approximately 40 general practices to participate in PPA CMR. PPA CRM starts with an online risk estimation. Patients with a score above risk threshold are invited to the GP for additional measurements, detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling. Follow –up will be one year, necessary data are collected by questionnaires and extraction from and the GPs’ electronic medical records. To determine factors for non-participation we will send non-participants questionnaires and we will asses al characteristics of participating practices. Several response-enhancing strategies will be tested in different subgroups.
COUNTRY OF RECRUITMENT: The Netherlands
Study objective
“Personalized Prevention Approach for CardioMetabolic Risk” (PPA CMR), a prevention program for cardiometabolic disease (CMD) combined with an individualized lifestyle intervention, is effectiveness and cost-effectiveness when implemented in primary care.
Study design
Intervention group:
- T=0 months: baseline measure for all patients
- T=6 months: follow-up measure for patients with increased risk
- T=12 months: follow-up measure for all patients
Control group:
- T=0 months: baseline measure for all patients
- T=12 months: follow-up measure for all patients
- T=18 months: follow-up measure for patients with increased risk
- T=24 months: follow-up measure for all patients
Intervention
The intervention is the CMD prevention program “Personalized Prevention Approach for CardioMetabolic Risk” (PPA CMR). We use an online risk estimation as screening tool for patients with an increased risk for CMD. Patients with a score above risk threshold are offered additional measurements by their GP. The GP gives individual tailored lifestyle advice and treatment when indicated. Treatment will be a lifestyle program and/or drug treatment.
Ilse Badenbroek
Centrum voor Gezondheidswetenschappen en Eerstelijnsgeneeskunde, UMC Utrecht
Universiteitsweg 100, 3584 CG Utrecht
Utrecht 3508 GA
The Netherlands
088-7568164
integrate@umcutrecht.nl
Ilse Badenbroek
Centrum voor Gezondheidswetenschappen en Eerstelijnsgeneeskunde, UMC Utrecht
Universiteitsweg 100, 3584 CG Utrecht
Utrecht 3508 GA
The Netherlands
088-7568164
integrate@umcutrecht.nl
Inclusion criteria
Inclusion criteria for practices:
- The use of an Electronic Medical Record (EMR) system, from which electronic data extraction is possible, covering approximately 90% of all Dutch general practices.
Inclusion criteria for patients:
- Age between 45 and 70 years, according to the guideline of the Dutch College of GPs
Exclusion criteria
Exclusion criteria for practices:
- Previously performed systematic CMD screening of the entire or a non-random sample of the practice population.
Exclusion criteria for patients:
- Previous diagnosis of CMD according to EMR
- Receiving antihypertensive and/or lipid-lowering treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4126 |
| NTR-old | NTR4277 |
| Other | METC UMC Utrecht : Protocolnumber: WAG/om/13/055866 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |