RecruitingNot ApplicableNCT06666452

COMFI - a COMbined Fatigue Intervention

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

Sponsor

The Danish Center for Expertise in Rheumatology

Enrollment

40 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Psoriatic Arthritis (PsA)Rheumatoid Arthritis (RA)Spondyloarthritis (SpA)Inflammatory Arthritis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combined fatigue program (COMFI) for people with rheumatoid arthritis, psoriatic arthritis, or spondyloarthritis who experience persistent, significant fatigue. The program combines physical exercise with other approaches like pacing and behavioral strategies, delivered in a group setting. **You may be eligible if...** - You are 18 or older - You have a rheumatologist-confirmed diagnosis of rheumatoid arthritis, psoriatic arthritis, or spondyloarthritis - You have experienced significant fatigue for at least 3 months (rated 60 or above on a 0-100 scale) - Your disease is currently stable — no planned medication changes and no changes in the past 3 months - You are affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund - You can speak and write Danish or Swedish well enough to participate in group discussions **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a serious illness such as cancer, severe heart failure, or kidney failure - You have poorly controlled diabetes or thyroid disease - You have unstable psychiatric illness or severe cognitive problems (like dementia) - Your fatigue is primarily caused by post-COVID syndrome or chronic fatigue syndrome - You are already participating in another study that could affect fatigue Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCOMFI - a COMbined Fatigue Intervention

The COMFI intervention is a 24-week group-based outpatient fatigue intervention consisting of 1) Six group sessions based on CBA covering topics such as fatigue and related factors, PA, trying out PA, energy management, and enhancing peer support 2) a seventh group session intended as a booster session in week 24, 3) one optional individual session in week 6-9 of the intervention, and 4) a support line in week 13-23 of COMFI.