Condition category
Circulatory System
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
17/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr C. Dingemanse

ORCID ID

Contact details

GGD Zeeland
P.O. Box 345
Goes
4460 AS
Netherlands
+31 (0)11 3249484
christine.dingemanse@ggdzeeland.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PGO2006

Study information

Scientific title

Acronym

Study 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.

Ethics approval

Not provided at time of registration

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Health related quality of life (short-form questionnaire-36 [SF-36] and EQ-5D)

Overall trial start date

13/01/2006

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2000

Participant exclusion criteria

Elderly people living in residential homes or hospital

Recruitment start date

13/01/2006

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

GGD Zeeland
Goes
4460 AS
Netherlands

Sponsor information

Organisation

GGD Zeeland (The Netherlands)

Sponsor details

P.O. Box 345
Goes
4460 AS
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

Community of Soest

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Community of Amersfoort

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Community of Schouwen-Duiveland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Community of Reimerswaal

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Community of Kapelle

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Community of Goes

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Zorgkantoor

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Province of Zeeland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GGD Zeeland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stichting

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes