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van CCT (UK)

van CCT (UK)

Preventive health survey in elderly people.

- candidate number1968
- NTR NumberNTR664
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR7-feb-2006
- Secondary IDsPGO2006 
- Public TitlePreventive health survey in elderly people.
- Scientific TitleCommunity health survey for early detection of risk factors for cardiovascular diseases, depression, osteoporosis and falls in elderly people: randomized controlled trial.
- hypothesisParticipation in a health survey for elderly people (60-75 years) on risk factors for cardiovascular diseases, depression, osteoporosis and falls, followed by a subsequent personalized health advice from a community nurse on lifestyle modification and / or reference to local preventive activities, will lead to a decreased risk profile within the surveyed group and to a decrease in an abbreviated risk profile in comparison to a control group.
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Depression, Fall injuries, Osteoporosis
- Inclusion criteriaRandom selection of all community-dwelling elderly persons, aged 60-75 living in the regions Zuid-Beveland, Schouwen-Duiveland, Soest and Soesterkwartier (Amersfoort).
- Exclusion criteriaElderly in residential homes / hospital.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-jan-2006
- planned closingdate31-jul-2007
- Target number of participants2000
- InterventionsHealth survey for risk factors followed by personalized advice on lifestyle and/or advice to follow course to improve lifestyle. Health survey consists of anamnestic interview consisting of both validated questionnaires and physical examination. Control group will only receive questionnaires by mail.
- Primary outcomePercentage of persons with improvement of one step or more in risk profile. Risk profile = combination of risk factors for cardiovascular diseases (4 levels), depression (4 levels), osteoporosis (2 levels) and falls (4 levels), with level 1 = low risk, 4 = high risk.

For the comparison with the control group an abbreviated risk profile will be contructed from the risk factors that can be assessed by questionnaire.

Outcome will be assessed at start and 12 months later.
- Secondary outcomeHealth related quality of life (SF-36, EQ-5D).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator GGD (Municipal Health Service) Zeeland, University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
Stichting Centraal Fonds Reserves van Voormalig Vrijwillige Ziekenfondsverzekeringen (RvvZ), GGD Zeeland, Province of Zeeland, Zorgkantoor, Community of Goes, Community of Kapelle, Community of Reimerswaal, Community of Schouwen-Duiveland, Community of Amersfoort, Community of Soest
- PublicationsLiterature study on risk factors eligible for screening in elderly people living in the open community (internal report).
- Brief summary* Blinded selection of eligible persons from municipal database;
* Blinded randomization into health survey or questionnaire only, stratified by travel distance to health center (Zeeland locations only);
* Invitation by mail, with response card including reasons for non-response;
* In case of no reaction: telephonic contact requesting reason;
* Health survey consisting physical examination and validated questionnaires.
Control group will only receive questionnaires by mail.
* 85-90% expected to have at least one increased risk factor;
* Minimal improvement defined as one step in one of four factors of risk profile, which is expected for 5-14 % of the surveyed population;
* Follow-up at 12 months, consisting of the same health survey (physical examination / questionnaires);
* Health survey and advice can not be blinded. Only selection and analysis are blinded.
- Main changes (audit trail)
- RECORD7-feb-2006 - 9-dec-2009

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