Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02531282
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Trondheim Kommune
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Patient education Behavioral: Physical activity Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : December 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Sense of Coherence (SOC) according to SOC-13 questionnaire [ Time Frame: 1 year ]
    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.

  2. Psychological distress on the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 year ]
    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).

  3. Pain severity in Brief Pain Questionnaire [ Time Frame: 1 year ]
    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.

  4. Pain interference in Brief Pain Questionnaire [ Time Frame: 1 year ]
    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.

  5. Pain intensity on a Visual Analogue Scale 100-mm [ Time Frame: 1 year ]
    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).

  6. Quality of Life on EuroQoL (EQ-5D-5L) Instrument [ Time Frame: 1 year ]
    Self-reported using the EQ-5 Dimensional instrument. Measured at baseline, and 3-6-12 months after intervention.

  7. Well-being on Visual Analogue Self-Rating Scale 100-mm [ Time Frame: 1 year ]
    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).

  8. Pain related self-efficacy according to Pain Self-efficacy Questionnaire (PSEQ) [ Time Frame: 1 year ]
    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.

  9. Physical ability in 30-seconds chair-to-stand test. [ Time Frame: 1 year ]
    The 30 seconds chair to stand test (30CST) performed at baseline, and 3-6-12 months after intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531282


Locations
Layout table for location information
Norway
Trondheim Kommune, Friskliv og mestring
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Trondheim Kommune
Investigators
Layout table for investigator information
Study Director: Kjersti Grønning, phd Norwegian University of Science and Technology

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02531282     History of Changes
Other Study ID Numbers: 2015/1030
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Patient education as topic
Health promotion
Patient participation
Self efficacy

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms