Plain English Summary
Background and study aims
There are many risk factors associated with cardiovascular heart disease and stroke. These include having high blood pressure, being overweight, not taking enough exercise, high cholesterol and a unhealthy diet. This study is investigating whether a one hour session with a district nurse on how to reduce these risk factors can improve cardiovascular (heart and circulation) health among people over the age of 55.
Who can participate?
Adults aged 55 and registered at one of the participating primary care (GP) centers.
What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (intervention) fill in a health questionnaire, visit a laboratory for blood tests and then meet a district nurse for a structured health dialogue. During this health dialogue the participant is given information from the district nurse about results from their laboratory tests and questionnaire, shown as a health curve. He or she also, with the support of the district nurse, has the opportunity to plan changes to their lifestyle. Those in group 2 (control group) fill in the same questionnaire and also have blood tests but do not participate in the structured health dialogue with a district nurse. Those in group 3 (comparison group) only fill in the same questionnaire and have the same blood tests a year later, along with the participants in the other two groups.
What are the possible benefits and risks of participating?
Participants who have the health dialogue have the opportunity to get information and also motivation for change and improvement to their lifestyle. All participants get their laboratory test results. Participants visit a doctor if laboratory tests indicates a need for that.
Where is the study run from?
Västmanland County Council (Department of Public Health/Centre for Clinical Research), Sweden.
When is study starting and how long is it expected to run for?
May 2010 to December 2012
Who is funding the study?
1. County Council of Västmanland, Sweden
2. Centre for Clinical Research, Västmanland, Sweden.
Who is the main contact?
Mr Mats Hellstrand
mats.hellstrand@ltv.se
Trial website
Contact information
Type
Public
Primary contact
Mr Mats Hellstrand
ORCID ID
Contact details
Department of Public Health
County Council of Västmanland
Västerås
72189
Sweden
+46 21 17 64 33
mats.hellstrand@ltv.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A health dialogue intervention reduces cardiovascular risk factor levels: a population based randomized controlled trial in primary care setting with one year follow up
Acronym
Study hypothesis
Population at the age of 55 who participated in a primary care nurse led health dialogue have at one year follow up significant improved CVD risk factor levels concerning life style, stress and biological markers compared to control.
Ethics approval
Regional Ethical Review Board of Uppsala, Sweden, 15/12/2010, ref: 2010/427
Study design
A single-centre interventional study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Cardiovascular disease prevention
Intervention
A computerized randomization was made by the Center of Clinical Research, Västerås Hospital, from a list of 1320 inhabitants born 1956-1957 belonging to five primary care centers. Randomization was conducted within each primary care center. The study population of men and women was assigned to three groups, intervention (n=440), control (n=440) and comparison group (n=440).
Intervention group filled in a health questionnaire, visited a laboratory for blood tests and thereafter met a district nurse for a structured health dialogue.
Control group filled in the same questionnaire and visited the same laboratory examination, but received no health dialogue.
The comparison group was invited only at one year follow up, answering the same questionnaire and doing the same laboratory examination.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Weight, height, waist, hip, systolic and diastolic blood pressure, measured by a district nurse.
1.1.Weight was measured with light clothing and without shoes
1.2. Blood pressure was measured in the right arm in sitting position after five minutes rest.
1.3. BMI (kg/m2) was calculated as weight/ (height x height).
1.4. Waist circumference was measured in the standing position at the level midway between the 1.5. lower rib margin and the iliac crest.
1.6. Hip circumference was measured at the widest point between hip and buttock
1.7. Waist–hip ratio (WHR) was calculated as waist circumference divided by hip circumference (cm/cm)
1.8. Height was measured without shoes on a fixed wall measure to the nearest centimetre.
2. Cholesterol, HbA1c and fasting plasma glucose measured by laboratory staff.
3. Self reported variables were physical activity, alcohol consumption last week, diet, smoking habits and stress.
All outcomes are measured one year (11-13 months) after baseline measurement and on all participants in the intervention and control group. Baseline measurement was carried out April-December 2011.
Secondary outcome measures
Sub group analysis on high risk groups based on the same measurements as for primary outcomes.
Definition of high risk factor levels: BMI ≥27 for men and BMI ≥29 for women, WHR ≥0.95 for men and ≥0.83 for women, systolic blood pressure ≥140, diastolic blood pressure ≥90, inactive or light physical activity following four degree scale, diet points ≥6 following eleven degree scale, alcohol ≥25 cl 40% liquor equivalents/week for men and ≥17 for women and cholesterol ≥5.0 mmol/l.
Overall trial start date
31/05/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inhabitants at the age of 54 or 55 years old at baseline year 2011, registered at one of the five participating primary care centres.
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
1320 persons.
Participant exclusion criteria
No exclusion criteria were specified.
Recruitment start date
01/04/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Sweden
Trial participating centre
Västmanland County Council (Department of Public Health/Centre for Clinical Research), Sweden
Västerås
72189
Sweden
Sponsor information
Organisation
County Council of Västmanland
Sponsor details
Landstingshuset
Västerås
72189
Sweden
+46 21 17 30 00
landstinget@ltv.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Landstinget Västmanland (County Council of Västmanland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Center of Clinical Research, County Council of Västmanland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list