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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Patient education
Physical activity
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Patient education as topic, Health promotion, Patient participation, Self efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trondheim Kommune, Friskliv og mestring

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health promotion in patient education

Physical activity in groups

Arm Description

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 .

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. .

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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.
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.
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).
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.
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).
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.
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.

Full Information

First Posted
August 21, 2015
Last Updated
January 21, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
Trondheim Kommune
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1. Study Identification

Unique Protocol Identification Number
NCT02531282
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Trondheim Kommune

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Patient education as topic, Health promotion, Patient participation, Self efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health promotion in patient education
Arm Type
Experimental
Arm Description
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 .
Arm Title
Physical activity in groups
Arm Type
Active Comparator
Arm Description
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. .
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Activation Measure (PAM)- 13 items
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Sense of Coherence (SOC) according to SOC-13 questionnaire
Description
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.
Time Frame
1 year
Title
Psychological distress on the Hospital Anxiety and Depression Scale (HADS)
Description
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).
Time Frame
1 year
Title
Pain severity in Brief Pain Questionnaire
Description
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.
Time Frame
1 year
Title
Pain interference in Brief Pain Questionnaire
Description
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.
Time Frame
1 year
Title
Pain intensity on a Visual Analogue Scale 100-mm
Description
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).
Time Frame
1 year
Title
Quality of Life on EuroQoL (EQ-5D-5L) Instrument
Description
Self-reported using the EQ-5 Dimensional instrument. Measured at baseline, and 3-6-12 months after intervention.
Time Frame
1 year
Title
Well-being on Visual Analogue Self-Rating Scale 100-mm
Description
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).
Time Frame
1 year
Title
Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ)
Description
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.
Time Frame
1 year
Title
Physical ability in 30-seconds chair-to-stand test.
Description
The 30 seconds chair to stand test (30CST) performed at baseline, and 3-6-12 months after intervention.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjersti Grønning, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Trondheim Kommune, Friskliv og mestring
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27430319
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.
Results Reference
background
PubMed Identifier
30530580
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.
Results Reference
result
PubMed Identifier
30594190
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.
Results Reference
result
PubMed Identifier
29126444
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.
Results Reference
derived

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

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