A combined intervention to reduce fatigue in inflammatory arthritis
The Feasibility Test of a COMbined Fatigue Intervention (COMFI) for People With Inflammatory Athritis
This study is testing a new program that combines therapy and exercise to see if it can help people with inflammatory arthritis feel less tired and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Danish Center for Expertise in Rheumatology Academic / other |
| Locations | 2 sites (Sønderborg, Denmark and 1 other locations) |
| Trial ID | NCT06666452 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a new intervention called COMFI, which combines cognitive behavioral therapy and physical activity to address fatigue in patients with inflammatory arthritis. Fatigue is a common and debilitating symptom for individuals with conditions such as rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis. The intervention will be tested on patients who have experienced significant fatigue for at least three months, with the goal of improving their quality of life and daily functioning. Participants will be recruited from specific hospitals in Denmark and Sweden, and the study will assess the impact of the combined approach on fatigue severity and its effects on daily life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a rheumatologist-confirmed diagnosis of rheumatoid arthritis, psoriatic arthritis, or spondyloarthritis who have experienced significant fatigue.
Not a fit: Patients who are pregnant, critically ill, or unable to communicate effectively in Danish or Swedish may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fatigue and improve the quality of life for patients with inflammatory arthritis.
How similar studies have performed: Previous studies have shown that interventions involving physical activity or cognitive behavioral approaches can reduce fatigue in similar patient populations, indicating potential for success with this combined approach.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Sønderborg, Denmark and 1 other locations
- The Danish Hospital for Rheumatic Diseases — Sønderborg, Denmark, Denmark (Completed)
- Skåne University Hospital — Lund, Sweden, Sweden (Recruiting)
Study contacts
- Study coordinator: Astrid J Damgaard, PhD-student
- Email: adamgaard@danskgigthospital.dk
- Phone: 0045 7365 4094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.