Clinical trial NCT02531282: Effect of a Health Promotion Intervention for People With Chronic Pain at a Healthy Life Centre
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Patient education as topic
Health promotion
Patient participation
Self efficacy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Trondheim Kommune
First posted: 2015-08-24
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Activation Measure (PAM)- 13 items
timeFrame: 1 year
Secondary outcomes:
measure: Sense of Coherence (SOC) according to SOC-13 questionnaire
timeFrame: 1 year
measure: Psychological distress on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 year
measure: Pain severity in Brief Pain Questionnaire
timeFrame: 1 year
measure: Pain interference in Brief Pain Questionnaire
timeFrame: 1 year
measure: Pain intensity on a Visual Analogue Scale 100-mm
timeFrame: 1 year
measure: Quality of Life on EuroQoL (EQ-5D-5L) Instrument
timeFrame: 1 year
measure: Well-being on Visual Analogue Self-Rating Scale 100-mm
timeFrame: 1 year
measure: Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ)
timeFrame: 1 year
measure: Physical ability in 30-seconds chair-to-stand test.
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Trondheim Kommune, Friskliv og mestring
Study officials:
affiliation: Norwegian University of Science and Technology
name: Kjersti Grønning, phd
role: STUDY_DIRECTOR
References:
citation: Nost TH, Steinsbekk A, Bratas O, Gronning K. 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. Trials. 2016 Jul 18;17(1):325. doi: 10.1186/s13063-016-1462-6.
citation: Nost TH, Steinsbekk A, Bratas O, Gronning K. Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial. BMJ Open. 2018 Dec 9;8(12):e023017. doi: 10.1136/bmjopen-2018-023017.
citation: Nost TH, Steinsbekk A, Bratas O, Gronning K. Twelve-month effect of chronic pain self-management intervention delivered in an easily accessible primary healthcare service - a randomised controlled trial. BMC Health Serv Res. 2018 Dec 29;18(1):1012. doi: 10.1186/s12913-018-3843-x.
citation: Nost TH, Steinsbekk A, Riseth L, Bratas O, Gronning K. Expectations towards participation in easily accessible pain management interventions: a qualitative study. BMC Health Serv Res. 2017 Nov 10;17(1):712. doi: 10.1186/s12913-017-2668-3.