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

NCT02531282 | Completed

• 1 other identifier: 2015/1030
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Patient education as topic; Health promotion; Patient participation; Self efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• Pain interference in Brief Pain Questionnaire

  1 year

• Pain intensity on a Visual Analogue Scale 100-mm

  1 year

Study Arms (2)

Health promotion in patient education

EXPERIMENTAL

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

Physical activity in groups

ACTIVE COMPARATOR

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

Interventions

Patient education BEHAVIORAL

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.

Health promotion in patient education

Physical activity BEHAVIORAL

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.

Physical activity in groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pain for 3 months or more
• able to participate in one hour physical activity

You may not qualify if:

• not fluent in Norwegian
• chronic pain arising from active malignant disease
• serious mental health illness
• substance abuse issues

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Trondheim Kommune: collaborator

Study Sites (1)

Trondheim Kommune, Friskliv og mestring

Trondheim, Norway

Location

Related Publications (4)

• 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.

  PMID: 27430319 BACKGROUND

• 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.

  PMID: 30530580 RESULT

• 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.

  PMID: 30594190 RESULT

• 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.

  PMID: 29126444 DERIVED

MeSH Terms

Conditions

Chronic Pain; Patient Participation

Interventions

Patient Education as Topic; Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kjersti Grønning, phd

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 24, 2015
• Study Start: September 1, 2015
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

NO (1)