ISRCTN ISRCTN21267689
DOI https://doi.org/10.1186/ISRCTN21267689
Secondary identifying numbers PGO2006
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

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesParticipation 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) studiedFalls, osteoporosis, cardiovascular disease, depression
InterventionHealth 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 typeOther
Primary outcome measurePercentage 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.
Secondary outcome measuresHealth related quality of life (short-form questionnaire-36 [SF-36] and EQ-5D)
Overall study start date13/01/2006
Completion date31/07/2007

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants2000
Key inclusion criteriaRandom 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 criteriaElderly people living in residential homes or hospital
Date of first enrolment13/01/2006
Date of final enrolment31/07/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

GGD Zeeland
Goes
4460 AS
Netherlands

Sponsor information

GGD Zeeland (The Netherlands)
Industry

P.O. Box 345
Goes
4460 AS
Netherlands

ROR logo "ROR" https://ror.org/042s2nd27

Funders

Funder type

Government

Community of Soest

No information available

Community of Amersfoort

No information available

Community of Schouwen-Duiveland

No information available

Community of Reimerswaal

No information available

Community of Kapelle

No information available

Community of Goes

No information available

Zorgkantoor

No information available

Province of Zeeland

No information available

GGD Zeeland

No information available

Stichting

No information available

Central Fund Reserves of the Former Voluntary National Health Service Administration Insurances (Centraal Fonds van Voormalig Vrijwillige Ziekenfondsverzekeringen [RvvZ])

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan