Development and evaluation of a fibromyalgia self-management programme
| ISRCTN | ISRCTN40835371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40835371 |
| Secondary identifying numbers | N0077117143 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 12/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Hammond
Scientific
Scientific
Southern Derbyshire Acute Hosptials NHS Trust
Department of Rheumatology
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
| Phone | +44 (0)1332 347141 Ext 2418 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Null hypothesis: there is no significant difference in health status between people with fibromyalgia attending a relaxation programme and self management programme incorporating psycho-educational approaches. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Fibromyalgia |
| Intervention | 91 patients with fibromyalgia will be recruited over a 1 year period and randomly allocated to attend either a self-management programme or a relaxation programme. The self-management programme uses educational and behavioural strategies to increase use of self management methods. Both consist of 10 meetings. Outcomes will be evaluated using a self-report questionnaire mailed out before and at 4 and 10 months after intervention. |
| Intervention type | Other |
| Primary outcome measure | Measures of adherence with self-management strategies, functional, psychological and health status as well as demographic and health care utilisation information. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2002 |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 91 |
| Key inclusion criteria | People with fibromyalgia (diagnosed by Consultant Physician) attending the Rheumatology Department, aged over 18 years, able to read English. |
| Key exclusion criteria | People with severe disease/functional/psychological problems will be excluded. |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southern Derbyshire Acute Hosptials NHS Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Southern Derbyshire Acute Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2006 | Yes | No |
