Condition category
Musculoskeletal Diseases
Date applied
21/07/2017
Date assigned
06/08/2017
Last edited
28/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People with fibromyalgia (FM) are managed in both primary and secondary care, but its diagnosis and management remain a challenge for patients and healthcare professionals. Currently, there is no evidence of the outcome of treatment and rehabilitation of FM in Norway, or whether patient characteristics and content of the rehabilitation program influences patients' health outcome. Consequently, there is currently no attempt to target the rehabilitation practice to patient characteristics. The aim of this study is to examine three different aspects of rehabilitation for FM in Norway.

Who can participate?
Adults aged 18 to 70 who have FM

What does the study involve?
Participants are asked to complete a questionnaire about their current and planned rehabilitation, their general health and other information. This is completed before they receive rehabilitation, as well as six and 12 months after the end of rehabilitation.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
This study is being run by Norwegian National Advisory Unit on Rehabilitation in Rheumatology (Norway) and takes place in three regional coordination units for rehabilitation in Western, South-Eastern and Central Norway

When is the study starting and how long is it expected to run for?
April 2017 to June 2018

Who is funding the study?
Norwegian National Advisory Unit on Rehabilitation in Rheumatology (Norway)

Who is the main contact?
Professor Kåre Birger Hagen
k.b.hagen@medisin.uio.no

Trial website

Contact information

Type

Public

Primary contact

Prof Kåre Birger Hagen

ORCID ID

http://orcid.org/0000-0003-4155-7959

Contact details

Norwegian National Advisory Unit on Rehabilitation in Rheumatology
PO Box 23 Vinderen
Oslo
N-0319 Oslo
Norway
+47 22454855
k.b.hagen@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

Development and validation of a fibromyalgia rehabilitation screening tool

Acronym

FiRST

Study hypothesis

The aim of this study is to examine three distinct but inter-related aspects of rehabilitation for fibromyalgia (FM) including:
1. The course of FM in the context of the nature and quality of current at Norwegian rehabilitation institutions
2. Identification of specific factors that is associated with prognosis of FM in this context
3. Development and validation of a statistical model that can predict individual risk of a future outcome for patients with FM

Ethics approval

Norwegian Regional Committee for Medical Research Ethics (REK South-East), 22/02/2017, ref: 2016/2032

Study design

Multi-centre prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fibromyalgia

Intervention

When consent has been provided, a unique identifier for each participant is generated and registered in an online data collection tool. The participants receive an email or SMS with a unique link to the questionnaire, and asked to complete sections on general demographic information, current and planned treatment and rehabilitation, information about symptoms and possible prognostic factors for FM.

The questionnaires are completed one to three weeks before rehabilitation, and six and 12 months after inclusion.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Patient global impression of change (PGCI) is measured using the seven point self-reported Likert scale at six and 12 months

Secondary outcome measures

Work productivity and activity impairment is measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at six and 12 months

Overall trial start date

15/04/2016

Overall trial end date

31/12/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with Fibromyalgia referred to rehabilitation by their general practitioner
2. Men and women between 18 and 70 years of age admitted to the participating centre

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Inability to understand and speak Norwegian.

Recruitment start date

01/04/2017

Recruitment end date

30/06/2018

Locations

Countries of recruitment

Norway

Trial participating centre

Regional Coordination Unit for rehabilitation in South-Eastern Norway Regional Health Authority
Nesodden
N-1450 Nesoddtangen
Norway

Trial participating centre

Regional Coordination Unit for rehabilitation in Western Norway Regional Health Authority
Bergen
N-5021 Bergen
Norway

Trial participating centre

Regional Coordination Unit for rehabilitation in Central Norway Regional Health Authority
Levanger
N-7601 Levanger
Norway

Sponsor information

Organisation

Norwegian National Advisory Unit on Rehabilitation in Rheumatology

Sponsor details

PO Box 23 Vinderen
Oslo
N-0319
Norway
+47 22451500
postmottak@diakonsyk.no

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Norwegian National Advisory Unit on Rehabilitation in Rheumatology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. Additional documentation is available upon request. Planned publication of the study protocol.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes