Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients
- Conditions
- Cardiovascular Diseases
- Interventions
- Behavioral: Activate
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
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).
- 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
- Arm && Interventions
Group Intervention Description Intervention: Activate intervention Activate Participants in the intervention arm will visit their primary care nurse four times in a three-month period for structured and comprehensive support in achieving an improved level of physical activity.
- 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 Odijk-Visser
🇳🇱Heerhugowaard, Noord-Holland, Netherlands
GP Lienderweg
🇳🇱Asten, Brabant, Netherlands
GP Tjin a Ton and Parlevliet
🇳🇱Amstelveen, Noord-Holland, Netherlands
GP Timmerman
🇳🇱Drunen, Brabant, Netherlands
GP Parklaan
🇳🇱Hoevelaken, Gelderland, Netherlands
GP Emmers
🇳🇱s Hertogenbosch, Brabant, Netherlands
GP Klaar and Vincent
🇳🇱Ede, Gelderland, Netherlands
GP Buren
🇳🇱Buren, Gerlderland, Netherlands
GP Seinhorst
🇳🇱Hilversum, Noord Holland, Netherlands
GP De Kennemerpoort
🇳🇱Bennebroek, Noord-Holland, Netherlands
GP Munster
🇳🇱Heerhugowaard, Noord-Holland, Netherlands
GP van Steenis
🇳🇱Bunnik, Utrecht, Netherlands
GP Odijk
🇳🇱Odijk, Utrecht, Netherlands
GP Eedenburgh
🇳🇱Hilversum, Noord-Holland, Netherlands
GP Spelt
🇳🇱Wassenaar, Noord-Holland, Netherlands
GP Koedijk
🇳🇱Koedijk, Noord-Holland, Netherlands
GP De Hollenhorst
🇳🇱Nieuw Vennep, Noord-Holland, Netherlands
GP Jonker
🇳🇱Colmschate, Overijssel, Netherlands
GP Provostlaan
🇳🇱Bilthoven, Utrecht, Netherlands
GP Rosing and Bruins Slot
🇳🇱Markelo, Overijssel, Netherlands
GP Blanker, Thiele, Brand
🇳🇱Zwolle, Overijssel, Netherlands
GP Amarant
🇳🇱Kampen, Overijssel, Netherlands
GP De Bilt
🇳🇱De BIlt, Utrecht, Netherlands
GP Tolgaarde
🇳🇱Leusden, Utrecht, Netherlands
GP De Schans
🇳🇱Woudenberg, Utrecht, Netherlands
GP Sparreboom
🇳🇱Alphen aan den Rijn, Zuid-Holland, Netherlands
GP Lombok
🇳🇱Utrecht, Netherlands
GP Wiechen
🇳🇱Boskoop, Zuid-Holland, Netherlands
GP De Wiel
🇳🇱Schoonrewoerd, Zuid-Holland, Netherlands
GP Mozaiek
🇳🇱The Hague, Zuid-Holland, Netherlands
GP Loudon
🇳🇱The Hague, Zuid-Holland, Netherlands