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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Activate

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 Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3531 HX
    • GP Lombok
  • Brabant
    • Asten, Brabant, Netherlands, 5721CM
      • GP Lienderweg
    • Drunen, Brabant, Netherlands, 5151 HA
      • GP Timmerman
    • s Hertogenbosch, Brabant, Netherlands, 5235KG
      • GP Emmers
  • Gelderland
    • Ede, Gelderland, Netherlands, 6713 NS
      • GP Klaar and Vincent
    • Hoevelaken, Gelderland, Netherlands, 3871EE
      • GP Parklaan
  • Gerlderland
    • Buren, Gerlderland, Netherlands, 4116CW
      • GP Buren
  • Noord Holland
    • Hilversum, Noord Holland, Netherlands, 1223DT
      • GP Seinhorst
  • Noord-Holland
    • Amstelveen, Noord-Holland, Netherlands, 1186PJ
      • GP Tjin a Ton and Parlevliet
    • Bennebroek, Noord-Holland, Netherlands, 2121BB
      • GP De Kennemerpoort
    • Heerhugowaard, Noord-Holland, Netherlands, 1701 ER
      • GP Odijk-Visser
    • Heerhugowaard, Noord-Holland, Netherlands, 1701ER
      • GP Munster
    • Hilversum, Noord-Holland, Netherlands, 1215EK
      • GP Eedenburgh
    • Koedijk, Noord-Holland, Netherlands, 1831EK
      • GP Koedijk
    • Nieuw Vennep, Noord-Holland, Netherlands, 2152CA
      • GP De Hollenhorst
    • Wassenaar, Noord-Holland, Netherlands, 2241KE
      • GP Spelt
  • Overijssel
    • Colmschate, Overijssel, Netherlands, 7429BG
      • GP Jonker
    • Kampen, Overijssel, Netherlands, 8265 DN
      • GP Amarant
    • Markelo, Overijssel, Netherlands, 7475AG
      • GP Rosing and Bruins Slot
    • Zwolle, Overijssel, Netherlands, 8042AD
      • GP Blanker, Thiele, Brand
  • Utrecht
    • Bilthoven, Utrecht, Netherlands, 3723RC
      • GP Provostlaan
    • Bunnik, Utrecht, Netherlands, 3981EV
      • GP van Steenis
    • De BIlt, Utrecht, Netherlands, 3732BG
      • GP De Bilt
    • Leusden, Utrecht, Netherlands, 3831JR
      • GP Tolgaarde
    • Odijk, Utrecht, Netherlands, 3984MA
      • GP Odijk
    • Woudenberg, Utrecht, Netherlands, 3931 KJ
      • GP De Schans
  • Zuid-Holland
    • Alphen aan den Rijn, Zuid-Holland, Netherlands, 2408 LA
      • GP Sparreboom
    • Boskoop, Zuid-Holland, Netherlands, 2771 EN
      • GP Wiechen
    • Schoonrewoerd, Zuid-Holland, Netherlands, 4145NV
      • GP De Wiel
    • The Hague, Zuid-Holland, Netherlands, 2525CE
      • GP Mozaiek
    • The Hague, Zuid-Holland, Netherlands, 2593WB
      • GP Loudon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Activate intervention; 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.	Behavioral: Activate; The Activate intervention consists of four nurse-led consultations in a thee-month period. In the consultations patients receive structured and comprehensive support in achieving an improved level of physical activity. The Behavior Change Wheel was used to develop the Activate intervention, and led to a selection of 17 behavior change techniques, which are integrated in the Activate intervention
No Intervention: Control; Patients in the control arm will receive care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of physical activity measured with the Personal Activity Monitor (PAM AM300)	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).	baseline - 6 months of follow up

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential effect modifier: age	does age modify change in physical activity level	baseline
Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)	does depression modify change in physical activity level	baseline
Potential effect modifier: Body Mass Index (BMI)	does BMI modify change in physical activity level	baseline
Potential effect modifier: level of education	does education level modify change in physical activity	baseline
Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)	does social support modify change in level of physical activity	baseline,
Potential effect modifier: patient-provider relationship using the Communication Assessment Tool (CAT)	does the patient-provider relationship modify change in level of physical activity	baseline, 3 months and 6 months of follow up
Potential effect modifier: baseline amount of minutes of moderate to vigorous level of physical activity using the PAM AM300	does baseline amount of minutes of moderate to vigorous level of physical activity modify change in level of physical activity	baseline

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Study Chair: Marieke J. Schuurmans, PhD, UMC Utrecht; Principal Investigator: Heleen Westland, MSc, UMC Utrecht; Principal Investigator: Irene D Bos-Touwen, MSc, UMC Utrecht; Study Chair: Jaap CA Trappenburg, PhD, UMC Utrecht; Study Chair: Carin D Schröder, PhD, UMC Utrecht

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; self-management; primary care; behaviour change techniques; nurse-led; behaviour change wheel; Cardiovascular risk management; clustered RCT
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NL54286.041.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet