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RECRUITING

NCT06666452

COMFI - a COMbined Fatigue Intervention

Sponsor: The Danish Center for Expertise in Rheumatology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-01

Completion Date

2026-04

Last Updated

2025-08-15

Healthy Volunteers

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.

Inclusion Criteria: 1. Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above. 2. Must have experienced fatigue as a challenge for at least the last 3 months 3. A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis 4. 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. 5. Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund. 6. Age ≥18 years. 7. Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter. 8. The participant must be interested in actively participating and making changes to daily life to improve their condition. Exclusion Criteria: 1. Pregnant or breastfeeding 2. Critical/serious illness: * Diseases with an expected survival of \< 2 years (e.g., cancer) * Heart failure with NYHA class 3 or 4 * Kidney failure with eGFR \< 30 * Severe anemia - hemoglobin ≤ 5.0 mmol/L 3. Clarification of known diseases, which must be well-treated or in remission: * Diabetes: HbA1c \>53 mmol/mol is excluded if dysregulated * Thyroid disease: TSH: 0.4-4.0 mE/L. Excluded if dysregulated 4. A medical condition that would make the proposed interventions unsuitable/impossible for group participation or hinder the ability to give informed consent: * Unstable psychiatric illness * Dementia or other severe cognitive problems * Hearing loss/use of hearing aids (it must be clarified how the person feels about being in a group setting) * Other physical or mental conditions with the above effect 5. Conditions that may be the primary cause of fatigue: * Long-term effects after COVID-19 * Chronic fatigue syndrome 6. Participation in another research project that could affect fatigue (WORK-ON, INSELMA, SPINCODE) 7. Participation in the fatigue program for hospitalized patients or support in another way specifically related to fatigue 8. The participant must not have a planned rehabilitation stay (e.g., Danish Rheumatism Hospital, Sano, Montebello) or another program elsewhere that works with fatigue 9. If the participant cannot commit to attending on the scheduled dates in one of the two programs.

Locations (2)

The Danish Hospital for Rheumatic Diseases

Sønderborg, Denmark, Denmark

Skåne University Hospital

Lund, Sweden, Sweden

Clinical Research Directory

COMFI - a COMbined Fatigue Intervention

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (2)