Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT02725203
• Lead Sponsor: UMC Utrecht

Brief Summary

A two-armed, cluster randomized controlled trial will be conducted comparing the Activate intervention with care as usual in 31 general practices in the Netherlands, in which approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention focuses on increasing physical activity and is developed using the Behavior Change Wheel (BCW). The activate intervention consists of four nurse-led consultations divided over a 3-months period. Primary outcome is the level of physical activity measured with an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline amount of minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months of follow up.

Nurses will be trained in delivering the intervention by a one-day training and coaching sessions supervised. A process evaluation will be conducted.

Detailed Description

Self-management interventions are considered effective in chronic disease patients, but trials have shown inconsistent results and it is unknown which patients benefit most. Adequate self-management requires behaviour change in patients and in healthcare providers to equip them in supporting patients in changing their behaviour. To unravel effectiveness of self-management, a nurse-led intervention was developed targeting at one self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease: the Activate intervention. This study aims to evaluate the effectiveness of the Activate intervention, to identify which patient-related characteristics modify change in physical activity levels in patients at risk for CVD in primary care, and to conduct a process evaluation.

A two-armed, cluster randomized controlled trial will be conducted comparing the Activate intervention with care as usual in 31 general practices in the Netherlands, in which approximately 300 patients at risk for cardiovascular disease will participate. The Activate intervention focuses on increasing physical activity and is developed using the Behavior Change Wheel (BCW). The activate intervention consists of four nurse-led consultations divided over a 3-months period in which 17 behaviour change techniques (BCTs) are integrated. Primary outcome is the level of physical activity measured with an accelerometer . Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline amount of minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months of follow up.

Subsequently, the BCW was applied to analyse what behavior change is needed in nurses to deliver the Activate intervention adequately. This resulted in a one-day training and coaching sessions supervised by a health psychologist and included 21 BCT.

A process evaluation will be conducted to evaluate the training of nurses, fidelity, dose and reach of the Activate intervention, identify barriers and facilitators for implementation and to assess participants' satisfaction.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Aged 40-75

AND at least one of the following criteria:

• have a high blood pressure (≥ 140 mmHg) or are already treated for high blood pressure
• have a high total cholesterol (≥ 6.5 mmol/l) or already treated for high cholesterol
• have diabetes mellitus type 2 (DM2)
• have a positive family history of CVD AND Do not meet the Dutch Norm for Healthy Exercise according to the Short QUestionnaire to Asses Health (SQUASH).

Exclusion Criteria

• unable to give informed consent (eg. due to cognitive impairment),
• 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 or have severe psychiatric illness or chronic disorder(s) that seriously influence the ability to improve their psychical activity level.
• patients should not have participated in a program to increase their level of physical activity in the past 2 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
level of physical activity measured with the Personal Activity Monitor (PAM AM300)	baseline - 6 months of follow up	The amount of minutes of physical activity in the moderate (3-6 METabolic equivalent (METS)) and vigorous categories (≥6 METS) at 6 months of follow up will be considered as primary outcome measure. Patients will be asked to wear the accelerometer during 7 consecutive days for 12 hours a day at baseline (T0), 3 months of follow up (T1) and at 6 months of follow up (T2).

Secondary Outcome Measures

Name	Time	Method
Patient activation using the Patient Activation Measure (PAM-13)	baseline -3 months and 6 months of follow up	Patient activation using the Patient Activation Measure (PAM-13)
Health status using the EQ-5D	baseline - 6 months of follow up	Health status using the EQ-5D
Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS)	baseline - 3 months and 6 months of follow up	Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS), baseline, T0, T1, T2
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)	baseline -3 months and 6 months of follow up	Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (\<1,8 METS)

Trial Locations

Locations (31)

GP Lienderweg; 🇳🇱 Asten, Brabant, Netherlands

GP Timmerman; 🇳🇱 Drunen, Brabant, Netherlands

GP Emmers; 🇳🇱 s Hertogenbosch, Brabant, Netherlands

GP Klaar and Vincent; 🇳🇱 Ede, Gelderland, Netherlands

GP Parklaan; 🇳🇱 Hoevelaken, Gelderland, Netherlands

GP Buren; 🇳🇱 Buren, Gerlderland, Netherlands

GP Seinhorst; 🇳🇱 Hilversum, Noord Holland, Netherlands

GP Tjin a Ton and Parlevliet; 🇳🇱 Amstelveen, Noord-Holland, Netherlands

GP De Kennemerpoort; 🇳🇱 Bennebroek, Noord-Holland, Netherlands

GP Odijk-Visser; 🇳🇱 Heerhugowaard, Noord-Holland, Netherlands

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