NCT06666452 COMFI - a COMbined Fatigue Intervention
| NCT ID | NCT06666452 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Danish Center for Expertise in Rheumatology |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-10-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06666452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06666452 currently recruiting?
Yes, NCT06666452 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Danish Center for Expertise in Rheumatology to inquire about joining.
Where is the NCT06666452 trial being conducted?
This trial is being conducted at Sønderborg, Denmark, Lund, Sweden.
Who is sponsoring the NCT06666452 clinical trial?
NCT06666452 is sponsored by The Danish Center for Expertise in Rheumatology. The trial plans to enroll 40 participants.
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