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

NCT02725203 | Completed DMC

• 1 other identifier: NL54286.041.15
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 31

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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular risk management; behaviour change techniques; self-management; physical activity; nurse-led; behaviour change wheel; primary care; clustered RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  baseline - 3 months and 6 months of follow up

• Patient activation using the Patient Activation Measure (PAM-13)

  baseline -3 months and 6 months of follow up

• Health status using the EQ-5D

  baseline - 6 months of follow up

Other Outcomes (7)

• Potential effect modifier: age

  baseline

• Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)

  baseline

• Potential effect modifier: Body Mass Index (BMI)

  baseline

Study Arms (2)

Intervention: Activate intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in the control arm will receive care as usual.

Interventions

Activate BEHAVIORAL

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

Intervention: Activate intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (31)

GP Klaar and Vincent

Ede, Gelderland, 6713 NS, Netherlands

Location

GP Parklaan

Hoevelaken, Gelderland, 3871EE, Netherlands

Location

GP Buren

Buren, Gerlderland, 4116CW, Netherlands

Location

GP Emmers

's-Hertogenbosch, North Brabant, 5235KG, Netherlands

Location

GP Lienderweg

Asten, North Brabant, 5721CM, Netherlands

Location

GP Timmerman

Drunen, North Brabant, 5151 HA, Netherlands

Location

GP Tjin a Ton and Parlevliet

Amstelveen, North Holland, 1186PJ, Netherlands

Location

GP De Kennemerpoort

Bennebroek, North Holland, 2121BB, Netherlands

Location

GP Odijk-Visser

Heerhugowaard, North Holland, 1701 ER, Netherlands

Location

GP Munster

Heerhugowaard, North Holland, 1701ER, Netherlands

Location

GP Eedenburgh

Hilversum, North Holland, 1215EK, Netherlands

Location

GP Seinhorst

Hilversum, North Holland, 1223DT, Netherlands

Location

GP Koedijk

Koedijk, North Holland, 1831EK, Netherlands

Location

GP De Hollenhorst

Nieuw-Vennep, North Holland, 2152CA, Netherlands

Location

GP Spelt

Wassenaar, North Holland, 2241KE, Netherlands

Location

GP Jonker

Colmschate, Overijssel, 7429BG, Netherlands

Location

GP Amarant

Kampen, Overijssel, 8265 DN, Netherlands

Location

GP Rosing and Bruins Slot

Markelo, Overijssel, 7475AG, Netherlands

Location

GP Blanker, Thiele, Brand

Zwolle, Overijssel, 8042AD, Netherlands

Location

GP Sparreboom

Alphen aan den Rijn, South Holland, 2408 LA, Netherlands

Location

GP Wiechen

Boskoop, South Holland, 2771 EN, Netherlands

Location

GP De Wiel

Schoonrewoerd, South Holland, 4145NV, Netherlands

Location

GP Mozaiek

The Hague, South Holland, 2525CE, Netherlands

Location

GP Loudon

The Hague, South Holland, 2593WB, Netherlands

Location

GP Provostlaan

Bilthoven, Utrecht, 3723RC, Netherlands

Location

GP van Steenis

Bunnik, Utrecht, 3981EV, Netherlands

Location

GP De Bilt

De Bilt, Utrecht, 3732BG, Netherlands

Location

GP Tolgaarde

Leusden, Utrecht, 3831JR, Netherlands

Location

GP Odijk

Odijk, Utrecht, 3984MA, Netherlands

Location

GP De Schans

Woudenberg, Utrecht, 3931 KJ, Netherlands

Location

GP Lombok

Utrecht, 3531 HX, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 33757957 DERIVED

• 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.

  PMID: 32375491 DERIVED

• 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.

  PMID: 30753213 DERIVED

• 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.

  PMID: 30541460 DERIVED

• 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.

  PMID: 28228151 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marieke J. Schuurmans, PhD

  UMC Utrecht

  STUDY CHAIR

• Heleen Westland, MSc

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Irene D Bos-Touwen, MSc

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Jaap CA Trappenburg, PhD

  UMC Utrecht

  STUDY CHAIR

• Carin D Schröder, PhD

  UMC Utrecht

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSc

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: March 31, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

NL (31)