Condition category
Circulatory System
Date applied
25/11/2015
Date assigned
10/12/2015
Last edited
25/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

ltv.se

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes