FibromyalgiaNCT01035125
Effect of One Week Self-management Program in Patients With Fibromyalgia
A study testing Self-management program in people with Fibromyalgia, run by Revmatismesykehuset AS at 1 site in Norway.
Trial summary
The purpose of this study is to explore the effect of one week inpatient self-management program (SMP) in patients with fibromyalgia. The SMP is delivered as group education/activities by allied health professionals. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Fibromyalgia outlined by the American College of Rheumatology for one year or more
- Between 20 and 70 years old
- Native Norwegian speaking
- Own wishes about participating the self-management program
Who cannot join
- Participated in the hospitals' SMP before
- Cognitive dysfunction
- Problems with sight and hearing that not can be compensated
- Mental disorders except light or treated depressions
Trial locations and contacts
1 site in 1 country.
Norway1 site
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, 2609
About this study
Official title: A Study of Effect of One Week Self-management Program in Patients With Fibromyalgia
The purpose of this study is to explore the effect of one week inpatient self-management program (SMP) in patients with fibromyalgia. The SMP is delivered as group education/activities by allied health professionals.
Read the detailed description
This study will determine if one week inpatient SMP can reduce FM symptoms and increase patients self-efficacy, health status, quality of life and being active health consumers.
The one-week SMP is designed to help people manage their rheumatic disease and challenges in daily life. The program has the same core concepts as outpatient programmes and comprises information, discussions on how to cope with the disease and daily life, cognitive management skills, exercise, engagement in self-care and interactions with healthcare professionals. During the program, the inpatient education unit takes up to 16 patients and 5 relatives per week within one diagnostic group. Each educational session lasts for 1.5-2.5 hours and the physical activity sessions for 0.5-1 hour. In the evening group sessions, the patients are divided into small groups of approximately five participants. They talk together for one hour under leadership of one health professional who is educated in coaching. The focus is on coping with the disease and daily life.
For the intervention group there will be a one year follow up study.
- Conditions
- Fibromyalgia
- Being tested
- Self-management program
- Keywords
- Self-management, Self-efficacy, Coping, Health consumer, Patient education, Health related quality of life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management programBehavioural
Also called Patient education
Participants will receive a one week inpatient self-management program
| Study group | Role | What they receive |
|---|---|---|
| Waiting list | No intervention | Not described |
| Self-management program | Experimental | One week self-management program Receives: Behavioral: Self-management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
EC-17 (Effective Musculoskeletal Consumer Scale)
Measured: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
GHQ20 (General Health Questionnaire)
Measured: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Secondary outcomes (3)
FIQ (Fibromyalgia Impact Questionnaire)
Measured: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
SF-36 (Short Form Health Survey)
Measured: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Self-efficacy Scale
Measured: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revmatismesykehuset AS
- Sponsor type
- University, hospital or other
- Investigators
- Knut Mikkelsen, MD, Study chair, Revmatismesykehuset AS, Lillehammer, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035125
- Sponsor's protocol ID
- REK 39-07138b 1.2007.1416
- Status last verified
- Jul 2011
- First submitted
- 17 Dec 2009
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamnes B, Mowinckel P, Kjeken I, Hagen KB. Effects of a one week multidisciplinary inpatient self-management programme for patients with fibromyalgia: a randomised controlled trial. BMC Musculoskelet Disord. 2012 Sep 26;13:189. doi: 10.1186/1471-2474-13-189.
PubMed 23013162
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Effect of One Week Self-management Program in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01035125
- Acronym / sponsor ID
- REK 39-07138b 1.2007.1416
- Conditions
- Fibromyalgia
- Keywords
- Self-management, Self-efficacy, Coping, Health consumer, Patient education, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Revmatismesykehuset ASUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effect of one week inpatient self-management program (SMP) in patients with fibromyalgia. The SMP is delivered as group education/activities by allied health professionals.
Detailed description
This study will determine if one week inpatient SMP can reduce FM symptoms and increase patients self-efficacy, health status, quality of life and being active health consumers.
The one-week SMP is designed to help people manage their rheumatic disease and challenges in daily life. The program has the same core concepts as outpatient programmes and comprises information, discussions on how to cope with the disease and daily life, cognitive management skills, exercise, engagement in self-care and interactions with healthcare professionals. During the program, the inpatient education unit takes up to 16 patients and 5 relatives per week within one diagnostic group. Each educational session lasts for 1.5-2.5 hours and the physical activity sessions for 0.5-1 hour. In the evening group sessions, the patients are divided into small groups of approximately five participants. They talk together for one hour under leadership of one health professional who is educated in coaching. The focus is on coping with the disease and daily life.
For the intervention group there will be a one year follow up study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list | No intervention | – |
| Self-management program | Experimental | Behavioral: Self-management programOne week self-management program |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Fibromyalgia outlined by the American College of Rheumatology for one year or more
- Between 20 and 70 years old
- Native Norwegian speaking
- Own wishes about participating the self-management program
Key exclusion criteria (4 listed)
- Participated in the hospitals' SMP before
- Cognitive dysfunction
- Problems with sight and hearing that not can be compensated
- Mental disorders except light or treated depressions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management programAlso: Patient educationParticipants will receive a one week inpatient self-management program | Behavioural | Self-management program |
Primary outcome
EC-17 (Effective Musculoskeletal Consumer Scale)
Time frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
GHQ20 (General Health Questionnaire)
Time frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
3 secondary outcomes
FIQ (Fibromyalgia Impact Questionnaire)
Time frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
SF-36 (Short Form Health Survey)
Time frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Self-efficacy Scale
Time frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Derived from this study: PubMed 23013162Hamnes B, Mowinckel P, Kjeken I, Hagen KB. Effects of a one week multidisciplinary inpatient self-management programme for patients with fibromyalgia: a randomised controlled trial. BMC Musculoskelet Disord. 2012 Sep 26;13:189. doi: 10.1186/1471-2474-13-189.
Related trials for Fibromyalgia
Not yet recruiting
Art and Mindfulness in Fibromyalgia Rehabilitation at the University Museum
Fibromyalgia
RecruitingObservational study
Respiratory Function in Fibromiyalgia Syndrome
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Mikkelsen, MD study chair
Revmatismesykehuset AS, Lillehammer, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management program in people with Fibromyalgia, run by Revmatismesykehuset AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EC-17 (Effective Musculoskeletal Consumer Scale) (time frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01035125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.