Fibromyalgia on the move. Randomised study on the feasibility and effect of fast-tracked diagnosis.
| ISRCTN | ISRCTN77212411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77212411 |
| Secondary identifying numbers | NTR421 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 24/01/2012
- 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 M.E.A.L. Kroese
Scientific
Scientific
University Hospital Maastricht
BZe VII - Transmurale Zorg
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3874406 |
|---|---|
| mkroes@adcc.azm.nl |
Study information
| Study design | Randomised single blind active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | The aim of this study is to care for patients with fibromyalgia more efficiently through the cooperation of the rheumatologist and the nurse specialist. Because of this, the rheumatology outpatient department can be relieved partly, which can have a positive consequence on the waiting list for patients with other rheumatologic disorders. Besides, we expect that this new way of diagnostics will have a small therapeutic effect. First, the patient can be seen two and a half months earlier. At the moment, there is a three-month waiting list for fibromyalgia patients at the rheumatology outpatient departments, but at the nurse specialist there is only a three-week waiting list. This can have a favourable effect on uncertainty and fixation of the complaints. Furthermore, the nurse specialist has probably more time and by this more attention for the support of this patient group. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | 1. A fast-tracked diagnosis, in which the nurse specialist gathers data by a prestructured anamnesis, and sets in screening diagnostics. At the end of the visit, the rheumatologist is involved. He is able to accept or reject the diagnosis in a shorter time on the basis of the available data. 2. Regular visit at the rheumatology outpatient clinic |
| Intervention type | Other |
| Primary outcome measure | 1. Social participation 2. Medical consumption 3. Quality of life |
| Secondary outcome measures | 1. Pain 2. Anxiety 3. Catastrophying 4. Fatigue 5. Disability 6. Self-efficacy |
| Overall study start date | 24/11/2003 |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 188 |
| Key inclusion criteria | 1. Suspicion fibromyalgia 2. First visit to rheumatology outpatient clinic 3. Age 18-65 4. Be able to understand Dutch language |
| Key exclusion criteria | 1. Comorbidity locomotor apparatus 2. Involved in an appeal concerning disability payment |
| Date of first enrolment | 24/11/2003 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Hospital Maastricht
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
Academic Hospital Maastricht (AZM) (The Netherlands)
Not defined
Not defined
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3876543 |
|---|---|
| info@azm.nl | |
"ROR" |
https://ror.org/02d9ce178 |
Funders
Funder type
Other
Care Funds (Zorgvernieuwingsgelden) (Netherlands)
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 | 15/09/2008 | Yes | No | |
| Results article | results | 01/07/2011 | Yes | No |
