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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 July 2021 |
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Main ID: |
ISRCTN96836577 |
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Date of registration:
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12/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Improved management of patients with fibromyalgia: Implementation and evaluation of an integrated care model
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Scientific title:
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Evaluation of a multicomponent rehabilitation program for patients with fibromyalgia in primary health care compared to treatment as usual combined with a short patient education program: Effects on patient global impression of change, disease related symptoms, physical activity and work ability |
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Date of first enrolment:
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01/11/2016 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN96836577 |
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Study type:
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Interventional |
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Study design:
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Multi-centre randomised controlled trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Norway
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Heidi A.
Zangi |
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Address:
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National Advisory Unit on Rehabilitation in Rheumatology
PO Box 23 Vinderen
0319
Oslo
Norway |
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Telephone:
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+47 (0)93054517 |
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Email:
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heidi.zangi@diakonsyk.no |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Rheumatologist confirmed diagnosis of fibromyalgia according to the American College of Rheumatology 2011 criteria
2. Aged between 20 and 50
Exclusion criteria:
1. Comorbid inflammatory rheumatic disease
2. Serious psychiatric disorder
3. Other disease impeding physical activity
4. Not at all been working during the last two years because of disease
5. Not able to understand and speak Norwegian
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia/widespread musculoskeletal pain
Musculoskeletal Diseases
Fibromyalgia/widespread musculoskeletal pain
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Intervention(s)
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Participants will be randomised one of two groups:
Intervention group: Participants take part in a multicomponent rehabilitation programme in their home municipality. The programme comprises a 10-session mindfulness-based Vitality Training Programme (VTP) followed by 8 weeks tailored physical exercise supervised by a physiotherapist at a Healthy Life Center.
Control group: Participants will receive treatment as usual in primary care, i.e. GP consultations and any physical activity as usual. They will be offered the VTP after completion of the last data collection, i.e. one year after inclusion.
Participants in both groups are followed up at 4 months (end of VTP) and 12 months post-randomisation.
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Primary Outcome(s)
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Patient global impression of change (PGIC) measured by a 7-point self-reported Likert scale ranging from 1 (“I feel very much worse”) through 4 (“no change”) to 7 (“I feel very much better”) one year after inclusion. Scores of 6 and 7 are considered clinically relevant improvement. The primary outcome will be measured after completion of the VTP (4 months) and at 12 months follow-up.
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Secondary Outcome(s)
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All outcomes will be measured at baseline (before randomisation), at 4 months and 12 months:
1. Pain measured by Numeric Rating Scale (NRS, 0-10)
2. Fatigue measured by Numeric Rating Scale (NRS, 0-10)
3. Sleep quality measured by Numeric Rating Scale (NRS, 0-10)
4. Psychological distress measured by General Health Questionnaire-12 (GHQ-12)
5. Physical activity measured by 4 questions from the Norwegian HUNT-study
6. Work ability measured by the Work Productivity and Activity Impairment Questionnaire (WPAI)
Added 04/05/2021:
7. Tendency to be mindful measured using the Five Facet Mindfulness Questionnaire (FFMQ) at baseline (before randomisation), at 4 months and 12 months
8. Motivation and barriers to physical activity measured using the Exercise Beliefs and Exercise Habits questionnaire at baseline (before randomisation), at 4 months and 12 months
9. Health-related quality of life measured using the EuroQol (EQ-5D-5L) at baseline (before randomisation), at 4 months and 12 months
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Source(s) of Monetary Support
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South-Eastern Norway Regional Health Authority
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Ethics review
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Status:
Approval date:
Contact:
Regional Committees for Medical and Health Research Ethics, 04/02/2016, ref: 2015/2447
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/05/2020 |
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URL:
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