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

Autor: Niek J. de Wit, Heleen Westland, Irene D. Bos-Touwen, Marieke J. Schuurmans, Jaap C.A. Trappenburg, Carin D. Schröder
Jazyk: angličtina
Předmět:
Male
Time Factors
Health Behavior
Psychological intervention
Medicine (miscellaneous)
Cardiovascular risk management
Disease
Nurse-led
Coaching
Study Protocol
0302 clinical medicine
Clinical Protocols
Behavior Therapy
Risk Factors
Behaviour change techniques
Health care
Medicine
Pharmacology (medical)
030212 general & internal medicine
Cluster randomised controlled trial
Self-management
Middle Aged
Primary care
Treatment Outcome
Cardiovascular Diseases
Research Design
Female
Behaviour change wheel
Adult
medicine.medical_specialty
Fitness Trackers
Risk Assessment
03 medical and health sciences
Social support
Patient Education as Topic
Intervention (counseling)
Journal Article
Humans
Healthy Lifestyle
Exercise
Aged
Primary Care Nursing
Primary Health Care
Physical activity
business.industry
Cluster RCT
Protective Factors
Actigraphy
Self Care
Physical therapy
sense organs
business
Risk Reduction Behavior
030217 neurology & neurosurgery
Zdroj: Trials [E], 18(1). BioMed Central
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-017-1823-9
Popis: Background Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. Methods/design A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants’ satisfaction. Discussion To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice. Trial registration ClinicalTrials.gov identifier: NCT02725203. Registered on 25 March 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1823-9) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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