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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725203
• Other study ID #: NL54286.041.15
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Netherlands	GP Sparreboom	Alphen aan den Rijn	Zuid-Holland
Netherlands	GP Tjin a Ton and Parlevliet	Amstelveen	Noord-Holland
Netherlands	GP Lienderweg	Asten	Brabant
Netherlands	GP De Kennemerpoort	Bennebroek	Noord-Holland
Netherlands	GP Provostlaan	Bilthoven	Utrecht
Netherlands	GP Wiechen	Boskoop	Zuid-Holland
Netherlands	GP van Steenis	Bunnik	Utrecht
Netherlands	GP Buren	Buren	Gerlderland
Netherlands	GP Jonker	Colmschate	Overijssel
Netherlands	GP De Bilt	De BIlt	Utrecht
Netherlands	GP Timmerman	Drunen	Brabant
Netherlands	GP Klaar and Vincent	Ede	Gelderland
Netherlands	GP Munster	Heerhugowaard	Noord-Holland
Netherlands	GP Odijk-Visser	Heerhugowaard	Noord-Holland
Netherlands	GP Eedenburgh	Hilversum	Noord-Holland
Netherlands	GP Seinhorst	Hilversum	Noord Holland
Netherlands	GP Parklaan	Hoevelaken	Gelderland
Netherlands	GP Amarant	Kampen	Overijssel
Netherlands	GP Koedijk	Koedijk	Noord-Holland
Netherlands	GP Tolgaarde	Leusden	Utrecht
Netherlands	GP Rosing and Bruins Slot	Markelo	Overijssel
Netherlands	GP De Hollenhorst	Nieuw Vennep	Noord-Holland
Netherlands	GP Odijk	Odijk	Utrecht
Netherlands	GP Emmers	s Hertogenbosch	Brabant
Netherlands	GP De Wiel	Schoonrewoerd	Zuid-Holland
Netherlands	GP Loudon	The Hague	Zuid-Holland
Netherlands	GP Mozaiek	The Hague	Zuid-Holland
Netherlands	GP Lombok	Utrecht
Netherlands	GP Spelt	Wassenaar	Noord-Holland
Netherlands	GP De Schans	Woudenberg	Utrecht
Netherlands	GP Blanker, Thiele, Brand	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Potential effect modifier: age	does age modify change in physical activity level	baseline
Other	Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)	does depression modify change in physical activity level	baseline
Other	Potential effect modifier: Body Mass Index (BMI)	does BMI modify change in physical activity level	baseline
Other	Potential effect modifier: level of education	does education level modify change in physical activity	baseline
Other	Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)	does social support modify change in level of physical activity	baseline,
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Health status using the EQ-5D	Health status using the EQ-5D	baseline - 6 months of follow up