|- candidate number||1968|
|- NTR Number||NTR664|
|- Date ISRCTN created||7-jun-2006|
|- date ISRCTN requested||16-mei-2006|
|- Date Registered NTR||7-feb-2006|
|- Secondary IDs||PGO2006 |
|- Public Title||Preventive health survey in elderly people.|
|- Scientific Title||Community health survey for early detection of risk factors for cardiovascular diseases, depression, osteoporosis and falls in elderly people: randomized controlled trial.|
|- hypothesis||Participation 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) studied||Cardiovascular disease, Depression, Fall injuries, Osteoporosis|
|- Inclusion criteria||Random selection of all community-dwelling elderly persons, aged 60-75 living in the regions Zuid-Beveland, Schouwen-Duiveland, Soest and Soesterkwartier (Amersfoort).|
|- Exclusion criteria||Elderly in residential homes / hospital.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-jan-2006|
|- planned closingdate||31-jul-2007|
|- Target number of participants||2000|
|- Interventions||Health 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 outcome||Percentage 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 outcome||Health related quality of life (SF-36, EQ-5D).|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| C. Dingemanse|
|- CONTACT for SCIENTIFIC QUERIES||Dr. H.F. Stel, van|
|- Sponsor/Initiator ||GGD (Municipal Health Service) Zeeland, University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care|
(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|
|- Publications||Literature 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)|
|- RECORD||7-feb-2006 - 9-dec-2009|