The main objective of this study is to evaluate the effectiveness of the Activate intervention in adult patients at risk for cardiovascular disease (CVD) in primary care. Secondary aims are to identify which patient-related characteristics modify…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cardiovasculair risico
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is level of physical activity measured with the Personal
Activity Monitor.
Secondary outcome
Secondary outcomes are sedentary behaviour, self-efficacy for physical
activity, patient activation and health status (EQ-5D). Potential
patient-related effect modifiers are age, body mass index, level of education,
social support, anxiety and depressive symptoms, patient-provider relationship
and baseline amount of minutes of physical activity. Furthermore a process
evaluation will be conducted to evaluate the fidelity, dose and reach of the
Activate intervention, identify barriers and facilitators for implementation,
and to assess the satisfaction of participants. Data will be collected at
baseline, at 3 months of follow up and at 6 months of follow up.
Background summary
Self-management interventions are considered effective in chronic disease
patients, but trials have shown inconsistent results and it is unknown which
patients benefit most. To unravel this variance in effect size focus is needed
on specific homogeneous components of self-management and its success across
heterogeneous subgroups of chronic disease patients who can benefit from
behaviour change. A systematically designed behaviour change intervention using
the Behaviour Change Wheel is developed to increase the level of physical
activity in patients at risk for cardiovascular disease in primary care - the
Activate intervention. The Activate intervention consists of four consultations
integrating effective behaviour change techniques and high-standard training of
health care providers.
Study objective
The main objective of this study is to evaluate the effectiveness of the
Activate intervention in adult patients at risk for cardiovascular disease
(CVD) in primary care. Secondary aims are to identify which patient-related
characteristics modify change in physical activity levels in patients at risk
for CVD in primary care and to perform a process evaluation.
Study design
a clustered randomized controlled trial will be conducted to compare support in
physical activity in the Activate intervention with care as usual. Clustering
is at the level of the general practice.
Intervention
Participants in the intervention group will visit their practice nurse 4 times
in a 3-month period for structured and comprehensive support in achieving an
improved level of physical activity. Patients in the control group will receive
care as usual.
Study burden and risks
Since the Activate intervention concerns additional support in primary care,
which is familair to the patient, in their neighbourhood, and supplementary to
their routine care, we assume participation will be of minimal burden to the
patient. The risk of participation is negliglible since participation entails
extra (low burden) consultations, use of accelerometer and low burden
questionnaires, and measurements.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
Eligible patients have at least one of the following risk factors of cardiovascular risk management according to the Dutch guideline for Cardiovascular risk management: ;Aged 40-75;AND
* 1 of the following criteria ;1. have a high blood pressure (* 140 mmHg) or are already treated for high blood pressure
2. have a high total cholesterol (* 6.5 mmol/l) or already treated for high cholesterol
3. have diabetes mellitus type 2 (DM2)
4. have a positive family history of CVD;AND;Not adhere to the Dutch Norm for Healthy Exercise according to a self-reported questionnaire
Exclusion criteria
- Have participated in a program to increase their level of physical activity in the past 2 years.
- Are unable to give informed consent (eg. due to cognitive impairment)
- Are unable to speak, write and read Dutch
- Have contra-indications to increase their physical activity level (eg. unstable angina
pectoris, unstable heart failure, acute illness)
- Have a terminal illness
- Have severe psychiatric illness or chronic disorder(s) that seriously influence the ability to improve their psychical activity level
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54286.041.15 |