Contact information
Type
Scientific
Primary contact
Dr M.E.A.L. Kroese
ORCID ID
Contact details
University Hospital Maastricht
BZe VII - Transmurale Zorg
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3874406
mkroes@adcc.azm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR421
Study information
Scientific title
Acronym
Study hypothesis
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
Received from local medical ethics committee
Study design
Randomised single blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
24/11/2003
Overall trial end date
01/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Suspicion fibromyalgia
2. First visit to rheumatology outpatient clinic
3. Age 18-65
4. Be able to understand Dutch language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
188
Participant exclusion criteria
1. Comorbidity locomotor apparatus
2. Involved in an appeal concerning disability payment
Recruitment start date
24/11/2003
Recruitment end date
01/11/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Hospital Maastricht
Maastricht
6202 AZ
Netherlands
Sponsor information
Organisation
Academic Hospital Maastricht (AZM) (The Netherlands)
Sponsor details
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
info@azm.nl
Sponsor type
Not defined
Website
Funders
Funder type
Other
Funder name
Care Funds (Zorgvernieuwingsgelden) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18759317
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21459951
Publication citations
-
Results
Kroese ME, Schulpen GJ, Bessems MC, Severens JL, Nijhuis FJ, Geusens PP, Landewé RB, Substitution of specialized rheumatology nurses for rheumatologists in the diagnostic process of fibromyalgia: a randomized controlled trial., Arthritis Rheum., 2008, 59, 9, 1299-1305, doi: 10.1002/art.24018.
-
Results
Kroese ME, Severens JL, Schulpen GJ, Bessems MC, Nijhuis FJ, Landewé RB, Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial., J. Rheumatol., 2011, 38, 7, 1413-1422, doi: 10.3899/jrheum.100753.