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

Sponsor

UMC Utrecht (Other)

Overall Status

Completed

CT.gov ID

NCT02725203

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

195

Enrollment

Locations

Arms

Duration (Months)

6.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Behavioral: Activate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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)
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
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GP Lienderweg	Asten	Brabant	Netherlands	5721CM
2	GP Timmerman	Drunen	Brabant	Netherlands	5151 HA
3	GP Emmers	s Hertogenbosch	Brabant	Netherlands	5235KG
4	GP Klaar and Vincent	Ede	Gelderland	Netherlands	6713 NS
5	GP Parklaan	Hoevelaken	Gelderland	Netherlands	3871EE
6	GP Buren	Buren	Gerlderland	Netherlands	4116CW
7	GP Seinhorst	Hilversum	Noord Holland	Netherlands	1223DT
8	GP Tjin a Ton and Parlevliet	Amstelveen	Noord-Holland	Netherlands	1186PJ
9	GP De Kennemerpoort	Bennebroek	Noord-Holland	Netherlands	2121BB
10	GP Odijk-Visser	Heerhugowaard	Noord-Holland	Netherlands	1701 ER
11	GP Munster	Heerhugowaard	Noord-Holland	Netherlands	1701ER
12	GP Eedenburgh	Hilversum	Noord-Holland	Netherlands	1215EK
13	GP Koedijk	Koedijk	Noord-Holland	Netherlands	1831EK
14	GP De Hollenhorst	Nieuw Vennep	Noord-Holland	Netherlands	2152CA
15	GP Spelt	Wassenaar	Noord-Holland	Netherlands	2241KE
16	GP Jonker	Colmschate	Overijssel	Netherlands	7429BG
17	GP Amarant	Kampen	Overijssel	Netherlands	8265 DN
18	GP Rosing and Bruins Slot	Markelo	Overijssel	Netherlands	7475AG
19	GP Blanker, Thiele, Brand	Zwolle	Overijssel	Netherlands	8042AD
20	GP Provostlaan	Bilthoven	Utrecht	Netherlands	3723RC
21	GP van Steenis	Bunnik	Utrecht	Netherlands	3981EV
22	GP De Bilt	De BIlt	Utrecht	Netherlands	3732BG
23	GP Tolgaarde	Leusden	Utrecht	Netherlands	3831JR
24	GP Odijk	Odijk	Utrecht	Netherlands	3984MA
25	GP De Schans	Woudenberg	Utrecht	Netherlands	3931 KJ
26	GP Sparreboom	Alphen aan den Rijn	Zuid-Holland	Netherlands	2408 LA
27	GP Wiechen	Boskoop	Zuid-Holland	Netherlands	2771 EN
28	GP De Wiel	Schoonrewoerd	Zuid-Holland	Netherlands	4145NV
29	GP Mozaiek	The Hague	Zuid-Holland	Netherlands	2525CE
30	GP Loudon	The Hague	Zuid-Holland	Netherlands	2593WB
31	GP Lombok	Utrecht		Netherlands	3531 HX