Preventive health survey in elderly people

ISRCTN	ISRCTN21267689
DOI	https://doi.org/10.1186/ISRCTN21267689
Protocol serial number	PGO2006
Sponsor	GGD Zeeland (The Netherlands)
Funders	Community of Soest, Community of Amersfoort, Community of Schouwen-Duiveland, Community of Reimerswaal, Community of Kapelle, Community of Goes, Zorgkantoor, Province of Zeeland, GGD Zeeland, Stichting, Central Fund Reserves of the Former Voluntary National Health Service Administration Insurances (Centraal Fonds van Voormalig Vrijwillige Ziekenfondsverzekeringen [RvvZ])

Submission date: 07/06/2006
Registration date: 07/06/2006
Last edited: 17/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr C. Dingemanse
Scientific

GGD Zeeland
P.O. Box 345
Goes
4460 AS
Netherlands

Phone	+31 (0)11 3249484
Email	christine.dingemanse@ggdzeeland.nl

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Falls, osteoporosis, cardiovascular disease, depression
Intervention	Health survey for risk factors followed by personalized advice on lifestyle and/or advice of 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.
Intervention type	Other
Primary outcome measure(s)	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), where level 1 = low risk; 4 = high risk. For the comparison with the control group, an abbreviated risk profile will be constructed from the risk factors that can be assessed by questionnaire. Outcome will be assessed at start and 12 months later.
Key secondary outcome measure(s)	Health related quality of life (short-form questionnaire-36 [SF-36] and EQ-5D)
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	2000
Key inclusion criteria	Random selection of all community-dwelling elderly persons, aged 60-75 living in the Netherlands in the regions: Zuid-Beveland, Schouwen-Duiveland, Soest and Soesterkwartier (Amersfoort).
Key exclusion criteria	Elderly people living in residential homes or hospital
Date of first enrolment	13/01/2006
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

GGD Zeeland

Goes
4460 AS
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan