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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list