Expectations, effect and experiences of an easily accessible self-management intervention for people with chronic pain: study protocol for a randomised controlled trial with embedded qualitative study

摘要

AbstractBackground: People struggling with chronic pain may benefit from different types of non-pharmacologicalinterventions such as self-management courses. Self-management courses aim to increase participants’ skills andknowledge in managing chronic conditions. Community health-care services in Norway have increasingly establishedHealthy Life Centres (HLCs) to offer easily accessible interventions to people in need of support to better handle a lifewith chronic illness. The aim of this trial is to investigate the expectations, effect and experience of an easily accessible,group-based self-management course delivered at a HLC for people with chronic pain.Methods/Design: This is an open pragmatic two-armed randomised controlled trial with an embedded qualitativestudy. The intervention is a self-management course comprising education, discussions, exchange of experiencesbetween the participants, and physical movement exercises. The control group is offered a drop-in outdoorphysical activity. The intervention period is 6 weeks. The primary outcome is patient activation measured by thepatient activation measure (PAM). The secondary outcomes include measures of self-efficacy, pain and quality oflife. Data will be collected at baseline, and after 3, 6 and 12 months. Using a mixed linear model, the numberneeded in each arm to achieve a power of 80 % becomes 55. To allow for dropout, the aim is to include 120participants. Analysis will be done using mixed linear models. In the embedded qualitative study, we will performsemi-structured face-to-face interviews with a sample from both trial arms before randomisation and after 3 and12 months. The topics elaborated will be motivation for participation and experiences with the activity related topossible changes in managing and coping with chronic pain.Discussion: There is need for more knowledge on interventions delivering self-care support in an easily accessibleway that aim to reach those in need of this kind of health service. This trial will produce important knowledge onthe effect and the experiences of participants in such an easily accessible self-management course delivered inNorwegian public primary care.