Development and evaluation of a fibromyalgia self-management programme
| ISRCTN | ISRCTN40835371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40835371 |
| Protocol serial number | N0077117143 |
| Sponsor | Department of Health (UK) |
| Funder | Southern Derbyshire Acute Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Measures of adherence with self-management strategies, functional, psychological and health status as well as demographic and health care utilisation information. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Southern Derbyshire Acute Hosptials NHS Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
