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Clinical Trials/NCT02531282
NCT02531282
Completed
N/A

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

Norwegian University of Science and Technology1 site in 1 country121 target enrollmentSeptember 2015
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Norwegian University of Science and Technology
Enrollment
121
Locations
1
Primary Endpoint
Patient Activation Measure (PAM)- 13 items
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 4, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Study Sites (1)

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