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*Unravelling the effectiveness of a behaviour change intervention to enhance physical activity in nurse-led cardiovascular risk management: study protocol of a clustered-randomized controlled trial in primary care*

*Unravelling the effectiveness of a behaviour change intervention to enhance physical activity in nurse-led cardiovascular risk management: study protocol of a clustered-randomized controlled trial in primary care* - Activate study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45037
Enrollment
277
Registered
2015-10-21
Start date
2016-03-29
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovasculair risico at risk for heart and vessel disease cardiovascular risk

Interventions

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. Patie

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Primary outcome is level of physical activity measured with the Personal Activity Monitor.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)