Effect of a Health Promotion Intervention for People With Chronic Pain at a Healthy Life Centre

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Patient education; Behavioral: Physical activity

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Trondheim Kommune, Friskliv og mestring

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health promotion in patient education; The self-management patient education has been developed at the Healthy Life Centre in Trondheim municipality based on cognitive behavioural theory and psychomotor physiotherapy. The intervention is developed in a health promotion framework focusing on salutogenesis aiming to improve the participants ability to activate their own resources for health behaviour changes .	Behavioral: Patient education; Self-management patient education in groups once a week for 6 weeks. Each session include pain-related theory, group discussions and physical exercises focusing on posture and relaxation. Instructors with education in health promotion and behavioural change in addition to psychomotor physiotherapy.
Active Comparator: Physical activity in groups; Physical activity once a week for a period of 6 weeks in form of walking and simple strength exercises outdoor in groups led by an instructor. .	Behavioral: Physical activity; Physical activity once a week for a period of 6 weeks in form of walking and simple strength exercises outdoor in groups led by an instructor. Each session has a duration of one hour. The instructor has education in physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure (PAM)- 13 items	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sense of Coherence (SOC) according to SOC-13 questionnaire	Self-reported questionnaire, The SOC-13, at baseline, and 3-6-12 months after intervention. The questionnaire consists of 13 items with seven options for answers, each with a scoring range from 1 to 7, giving a total score from 13 to 91.	1 year
Psychological distress on the Hospital Anxiety and Depression Scale (HADS)	Self-reported questionnaire, the Hospital Anxiety and Depression Scale (HADS) at baseline, and 3-6-12 months after intervention. The questionnaire consists of 14 items producing a separate score for anxiety and depression. The instrument has a total range from 0 (best) to 42 (worst).	1 year
Pain severity in Brief Pain Questionnaire	Self-reported pain severity measured by 4 questions in the Brief Pain Inventory (BPI) instrument. All items in BPI are scored using a numeric rating scale from 0 to 10. Measured at baseline, and 3-6-12 months after intervention.	1 year
Pain interference in Brief Pain Questionnaire	Self-reported pain interference measured by 7 questions in the Brief Pain Inventory (BPI) instrument. All items in BPI are scored using a numeric rating scale from 0 to 10. Measured at baseline, and 3-6-12 months after intervention.	1 year
Pain intensity on a Visual Analogue Scale 100-mm	Self-reported experience of pain during the previous week using a one-item 100 mm Visual Analogue Scale at baseline, and 3-6-12 months after intervention. The anchoring points are "no pain" (0) and "intolerable pain" (100).	1 year
Quality of Life on EuroQoL (EQ-5D-5L) Instrument	Self-reported using the EQ-5 Dimensional instrument. Measured at baseline, and 3-6-12 months after intervention.	1 year
Well-being on Visual Analogue Self-Rating Scale 100-mm	Self-reported well-being measured by the Arizona Integrative Outcome Scale (AIOS) at baseline, and 3-6-12 months after intervention. This is a one-item 100 mm long Visual Analogue Self-Rating Scale followed by an instruction to reflect on the sense of well-being during the last month. The anchoring points are "worst you have ever been (0) and "best you ever been" (100).	1 year
Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ)	Self-reported pain self-efficacy using the instrument Pain Self-efficacy Questionnaire (PSEQ) at baseline, and 3-6-12 months after intervention. The questionnaire consist of 10 items scored on a range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs.	1 year
Physical ability in 30-seconds chair-to-stand test.	The 30 seconds chair to stand test (30CST) performed at baseline, and 3-6-12 months after intervention.	1 year

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Trondheim Kommune
• Investigators: Study Director: Kjersti Grønning, phd, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 4, 2017
• Study Completion (Actual): December 4, 2017

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimate): August 24, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Health promotion; Self efficacy; Patient participation; Patient education as topic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2015/1030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No