Effect of and Experiences With a Health Promotion Intervention for People With Chronic Pain at a Healthy Life Centre - an Open, Pragmatic, Randomized Controlled Trial With a Nested Qualitative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Patient Activation Measure (PAM)- 13 items
Study Overview
Brief Summary
The study's primary objective is to test the hypothesis that a group-based health promotion intervention with patient education and practical exercises delivered at a Healthy Life Centre increases patient activation in people living with chronic pain. Due to many people living with chronic pain, interventions focusing on self-management and coping are on the agenda in primary care. This study will investigate whether a Healthy Life Centre in a municipality is a suitable setting for interventions targeting people living with chronic pain. Short and long term effect of an intervention developed in a health promotion and salutogenic framework will be investigated in a randomized clinical trial.
Detailed Description
Previous research indicates that if self-management interventions are developed within a health promotion framework focusing on the participants' strengths, there is a beneficial effect on patient activation and thus on self-management behaviour. However, there is a lack of knowledge about which interventions will improve patient activation for persons with chronic pain. To be sustainable, such interventions should be delivered using the least possible amount of resources needed to get an effect. One way to do so is to deliver the intervention in primary care instead of in hospitals. The Healthy Life Centre is ideally situated to deliver these interventions. This is especially true due to their task of focusing on health promotion but also because they are set up to deliver low level interventions, meaning that it should be easy for everyone to access their services.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pain for 3 months or more
- •able to participate in one hour physical activity
Exclusion Criteria
- •not fluent in Norwegian
- •chronic pain arising from active malignant disease
- •serious mental health illness
- •substance abuse issues
Outcomes
Primary Outcomes
Patient Activation Measure (PAM)- 13 items
Time Frame: 1 year
Self-reported questionnaire at baseline, and 3- 6- 12 months after intervention. PAM-13 is an interval-level, uni-dimensional measure questionnaire with a four point scale with an additional not applicable option, giving a raw score from 13- 52, which is calibrated to a total score between 0 (less activated) to 100 (most activated).
Secondary Outcomes
- Pain interference in Brief Pain Questionnaire(1 year)
- Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ)(1 year)
- Quality of Life on EuroQoL (EQ-5D-5L) Instrument(1 year)
- Sense of Coherence (SOC) according to SOC-13 questionnaire(1 year)
- Psychological distress on the Hospital Anxiety and Depression Scale (HADS)(1 year)
- Pain severity in Brief Pain Questionnaire(1 year)
- Well-being on Visual Analogue Self-Rating Scale 100-mm(1 year)
- Pain intensity on a Visual Analogue Scale 100-mm(1 year)
- Physical ability in 30-seconds chair-to-stand test.(1 year)