Clinical trial NCT02725203: Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients
Official title: Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients With a Cardiovascular Risk: a Clustered-randomized Controlled Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular risk management
behaviour change techniques
self-management
physical activity
nurse-led
behaviour change wheel
primary care
clustered RCT
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2016-03-31
Enrollment: 195
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: level of physical activity measured with the Personal Activity Monitor (PAM AM300)
timeFrame: baseline - 6 months of follow up
Secondary outcomes:
measure: Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
timeFrame: baseline -3 months and 6 months of follow up
measure: Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS)
timeFrame: baseline - 3 months and 6 months of follow up
measure: Patient activation using the Patient Activation Measure (PAM-13)
timeFrame: baseline -3 months and 6 months of follow up
measure: Health status using the EQ-5D
timeFrame: baseline - 6 months of follow up
Other outcomes:
measure: Potential effect modifier: age
timeFrame: baseline
measure: Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Potential effect modifier: Body Mass Index (BMI)
timeFrame: baseline
measure: Potential effect modifier: level of education
timeFrame: baseline
measure: Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: baseline,
measure: Potential effect modifier: patient-provider relationship using the Communication Assessment Tool (CAT)
timeFrame: baseline, 3 months and 6 months of follow up
measure: Potential effect modifier: baseline amount of minutes of moderate to vigorous level of physical activity using the PAM AM300
timeFrame: baseline
Locations:
city: Asten
country: Netherlands
facility: GP Lienderweg
state: Brabant
city: Drunen
country: Netherlands
facility: GP Timmerman
state: Brabant
city: s Hertogenbosch
country: Netherlands
facility: GP Emmers
state: Brabant
city: Ede
country: Netherlands
facility: GP Klaar and Vincent
state: Gelderland
city: Hoevelaken
country: Netherlands
facility: GP Parklaan
state: Gelderland
city: Buren
country: Netherlands
facility: GP Buren
state: Gerlderland
city: Hilversum
country: Netherlands
facility: GP Seinhorst
state: Noord Holland
city: Amstelveen
country: Netherlands
facility: GP Tjin a Ton and Parlevliet
state: Noord-Holland
city: Bennebroek
country: Netherlands
facility: GP De Kennemerpoort
state: Noord-Holland
city: Heerhugowaard
country: Netherlands
facility: GP Odijk-Visser
state: Noord-Holland
city: Heerhugowaard
country: Netherlands
facility: GP Munster
state: Noord-Holland
city: Hilversum
country: Netherlands
facility: GP Eedenburgh
state: Noord-Holland
city: Koedijk
country: Netherlands
facility: GP Koedijk
state: Noord-Holland
city: Nieuw Vennep
country: Netherlands
facility: GP De Hollenhorst
state: Noord-Holland
city: Wassenaar
country: Netherlands
facility: GP Spelt
state: Noord-Holland
city: Colmschate
country: Netherlands
facility: GP Jonker
state: Overijssel
city: Kampen
country: Netherlands
facility: GP Amarant
state: Overijssel
city: Markelo
country: Netherlands
facility: GP Rosing and Bruins Slot
state: Overijssel
city: Zwolle
country: Netherlands
facility: GP Blanker, Thiele, Brand
state: Overijssel
city: Bilthoven
country: Netherlands
facility: GP Provostlaan
state: Utrecht
city: Bunnik
country: Netherlands
facility: GP van Steenis
state: Utrecht
city: De BIlt
country: Netherlands
facility: GP De Bilt
state: Utrecht
city: Leusden
country: Netherlands
facility: GP Tolgaarde
state: Utrecht
city: Odijk
country: Netherlands
facility: GP Odijk
state: Utrecht
city: Woudenberg
country: Netherlands
facility: GP De Schans
state: Utrecht
city: Alphen aan den Rijn
country: Netherlands
facility: GP Sparreboom
state: Zuid-Holland
city: Boskoop
country: Netherlands
facility: GP Wiechen
state: Zuid-Holland
city: Schoonrewoerd
country: Netherlands
facility: GP De Wiel
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: GP Mozaiek
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: GP Loudon
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: GP Lombok
Study officials:
affiliation: UMC Utrecht
name: Marieke J. Schuurmans, PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Heleen Westland, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Irene D Bos-Touwen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Jaap CA Trappenburg, PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Carin D Schröder, PhD
role: STUDY_CHAIR
References:
citation: Westland H, Trappenburg JCA, Schuurmans MJ, Zonneveld MH, Schroder CD. Fidelity of primary care nurses' delivery of a behavioural change intervention enhancing physical activity in patients at risk of cardiovascular disease: an observational study. BMJ Open. 2021 Mar 23;11(3):e046551. doi: 10.1136/bmjopen-2020-046551.
citation: Westland H, Schuurmans MJ, Bos-Touwen ID, de Bruin-van Leersum MA, Monninkhof EM, Schroder CD, de Vette DA, Trappenburg JC. Effectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial. Eur J Cardiovasc Nurs. 2020 Dec;19(8):721-731. doi: 10.1177/1474515120919547. Epub 2020 May 6.
citation: Westland H, Sluiter J, Te Dorsthorst S, Schroder CD, Trappenburg JCA, Vervoort SCJM, Schuurmans MJ. Patients' experiences with a behaviour change intervention to enhance physical activity in primary care: A mixed methods study. PLoS One. 2019 Feb 12;14(2):e0212169. doi: 10.1371/journal.pone.0212169. eCollection 2019.
citation: Westland H, Koop Y, Schroder CD, Schuurmans MJ, Slabbers P, Trappenburg JCA, Vervoort SCJM. Nurses' perceptions towards the delivery and feasibility of a behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: a qualitative study. BMC Fam Pract. 2018 Dec 12;19(1):194. doi: 10.1186/s12875-018-0888-1.
citation: Westland H, Bos-Touwen ID, Trappenburg JC, Schroder CD, de Wit NJ, Schuurmans MJ. Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial. Trials. 2017 Feb 22;18(1):79. doi: 10.1186/s13063-017-1823-9.