COMFI - a COMbined Fatigue Intervention

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.

Conditions

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

Interventions

BEHAVIORAL

COMFI - 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.

Sponsors & Collaborators

• Skaane University Hospital

  collaborator UNKNOWN

• Odense Patient Data Explorative Network

  collaborator OTHER

• The Danish Rheumatism Association

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Bristol Royal Infirmary

  collaborator UNKNOWN

• The Danish Center for Expertise in Rheumatology

  lead OTHER

Principal Investigators

• Jette Primdahl, Professor · The Danish Center for Expertise in Rheumatology

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-04-30

Completion

2026-04-30

Countries

• Denmark
• Sweden

Study Locations