COMFI - a COMbined Fatigue Intervention

Launched by THE DANISH CENTER FOR EXPERTISE IN RHEUMATOLOGY · Oct 29, 2024

Keywords

ClinConnect Summary

The COMFI trial is studying a new program designed to help people with inflammatory arthritis, like rheumatoid arthritis and psoriatic arthritis, who experience severe fatigue. This fatigue can be overwhelming and impact daily life, including work and social activities. The trial aims to combine two approaches: physical activity and cognitive behavioral therapy (which helps change negative thought patterns) to see if this combined method can effectively reduce fatigue. Participants will take part in group sessions over a few months, and their fatigue levels will be monitored at the start and then at 3, 6, and 12 months.

To be eligible for the trial, participants need to be at least 18 years old, have a confirmed diagnosis of one of the targeted conditions, and have been experiencing fatigue for at least three months. Additionally, they should be able to communicate well in Danish or Swedish and be stable in their medical treatment. Those who are pregnant, have serious health issues, or are participating in other fatigue-related research may not qualify. This trial will provide participants with support and tools to manage their fatigue better, and the researchers hope to learn if this combined approach is practical and beneficial.

Gender

ALL

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 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.