The Feasibility Test of a COMbined Fatigue Intervention (COMFI) for People With Inflammatory Athritis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue. Patients describe fatigue as overwhelming, unpredictable, challenging to manage, and affecting all areas of everyday life, including the ability to work. Studies have shown that interventions with physical activity or a cognitive behavioral approach can significantly reduce fatigue severity and/or impact in people with IA compared to usual care. To date, no studies have investigated the combined effect of CBA and PA on fatigue severity and impact in patients with IA. Therefore, the goal of this study is to test the feasibility of a newly developed fatigue intervention that combines a cognitive behavioral approach and physical activity (COMFI) in patients with inflammatory arthritis, who experience fatigue as a challenge in their everyday lives in Denmark and Sweden. The intervention will be tested in 4 groups (2 in Denmark and 2 in Sweden), and the participants will participate in 7 group sessions and 2 focusgroups interview in the evaluation. The primary outcome for the participants is fatigue, measured through patient-reported outcomes at baseline, 3, 6, and 12 months after baseline. This study will show if the intervention is feasible in practice and meaningful for the participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.

• Must have experienced fatigue as a challenge for at least the last 3 months

• A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis

• The patient is in a stable phase regarding disease activity. This means no current plans to adjust pharmacological treatment, and no changes in treatment in the last 3 months (DMARDs or steroids) incl. steroid injections.

• Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.

• Age ≥18 years.

• Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter.

• The participant must be interested in actively participating and making changes to daily life to improve their condition.

Locations
Other Locations
Denmark
The Danish Hospital for Rheumatic Diseases
COMPLETED
Sønderborg
Sweden
Skåne University Hospital
RECRUITING
Lund
Contact Information
Primary
Astrid J Damgaard, PhD-student
adamgaard@danskgigthospital.dk
0045 7365 4094
Backup
Jette Primdahl, Professor
jprimdahl@danskgigthospital.dk
0045 2420 6692
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 40
Treatments
Experimental: Intervention
The COMFI intervention
Sponsors
Collaborators: The Danish Rheumatism Association, University of Southern Denmark, Region of Southern Denmark, Skaane University Hospital, Odense Patient Data Explorative Network, Bristol Royal Infirmary
Leads: The Danish Center for Expertise in Rheumatology

This content was sourced from clinicaltrials.gov

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