|- candidate number||1751|
|- NTR Number||NTR421|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||10-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||Fibromyalgia on the move...! Randomised study on the feasibility and effect of fast-tracked diagnosis.|
|- Scientific Title||Randomised study on the feasibility and effect of fast-tracked diagnosis in fibromyalgia-patients.|
|- hypothesis||The aim of this study is to pass of the 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 rheumatology outpatient departments is at the moment a three-month waiting list for fibromyalgia patients, but at the nurse specialist a three-week. 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.|
|- Healt Condition(s) or Problem(s) studied||Fibromyalgia|
|- Inclusion criteria||1. Suspicion fibromyalgia; |
2. First visit rheumatology outpatient clinic;
3. Age 18-65;
4. Be able to understand Dutch language.
|- Exclusion criteria||1. Comorbidity locomotor apparatus;|
2. Involved in an appeal concering disability payment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-nov-2003|
|- planned closingdate||1-nov-2005|
|- Target number of participants||188|
|- Interventions||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 basis of the available data;|
2. Regular visit at the rheumatology outpatient clinic.
|- Primary outcome||1. Social participation;|
2. Medical consumption;
3. Qualtiy of life.
|- Secondary outcome||1. Pain;|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.E.A.L. Kroese|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G. Schulpen|
|- Sponsor/Initiator ||Academic Hospital Maastricht (azM)|
(Source(s) of Monetary or Material Support)
|- Publications||Arthritis Rheum. 2008 Sep 15;59(9):1299-305.|
|- Brief summary||The present medical care (diagnostics and treatment) of fibromyalgia patients has several bottlenecks. The rheumatology outpatient department of the university hospital Maastricht is having extensive waiting lists for a long time. Of the 1200 new patients a year, 350 are referred with (suspicion of) fibromyalgia. It seems to have several advantages to offer these patients a visit at a nurse specialist in the short (within 2-3 weeks instead of 3 months), in which the diagnosis is made under supervision of the rheumatologist. First, the patient can be diagnosed adequately without asking the present load of the outpatient clinic, which has a positive effect on the existing waiting list. Besides, a visit at a nurse specialist in the short means an earlier end of uncertainty about the sort complaints, which may have a positive effect on the course of the complaints, medical consumption and social participation. Furthermore, the nurse specialist has probably more time and by this more attention for the support of this patient group.|
The aim of this study is to pass of the care for patients with fibromyalgia more efficiently through the cooperation of the rheumatologist and the nurse specialist. The study is divisible into two parts, a process and an effect evaluation. The process evaluation concerns the feasibility (efficacy, safety, satisfaction, costs, and the length of the waiting list). The effect evaluation is aimed at the determination of a possible therapeutic effect of this new way of care in the outpatient clinic.
The overall research question are:
1.Is the fast-tracked diagnosis route a feasible (efficacious and efficient) alternative for the regular outpatient clinical care?
2.What is the therapeutic effect of the fast-tracked diagnosis route on fibromyalgia patients?
|- Main changes (audit trail)|
|- RECORD||10-okt-2005 - 15-sep-2008|