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The effectiveness and cost-effectiveness of an integrated cardio-metabolic risk assessment and treatment program in primary care: the INTEGRATE study


- candidate number15768
- NTR NumberNTR4277
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-nov-2013
- Secondary IDsProtocolnumber: WAG/om/13/055866 METC UMC Utrecht
- Public TitleThe effectiveness and cost-effectiveness of an integrated cardio-metabolic risk assessment and treatment program in primary care: the INTEGRATE study
- Scientific TitleThe effectiveness and cost-effectiveness of an integrated cardio-metabolic risk assessment and treatment program in primary care: the INTEGRATE study
- ACRONYMINTEGRATE study
- hypothesis“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.
- Healt Condition(s) or Problem(s) studiedCardiometabolic health, Prevention, Screening, Primary care, Efficacy
- Inclusion criteriaInclusion 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 criteriaExclusion 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-mrt-2017
- Target number of participants28500
- InterventionsThe 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.
- Primary outcome1. 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 outcome1. 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
- TimepointsIntervention 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
- Trial web sitehttp://www.integrateproject.nl/
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Ilse Badenbroek
- CONTACT for SCIENTIFIC QUERIESProf. Dr. N.J. Wit, de
- Sponsor/Initiator NIVEL, University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care, VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Dutch Diabetes Research Foundation, Innovatiefonds zorgverzekeraars
- PublicationsN/A
- Brief summaryThe 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
- Main changes (audit trail)28-3-2014: Change of start date (was 1-mrt-2014). Removal "For half of the practices, the presence of an integrated lifestyle program for patients with increased risk for CMD." in inclusion criteria.
- RECORD26-nov-2013 - 28-mrt-2014


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