COMFI - a COMbined Fatigue Intervention

NCT06666452 | Recruiting

• 2 other identifiers: COMFI-FeasibilityS-20232000 - 110
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

Fatigue; Intervention; cognitive behavioural approach; Physical activity

Outcome Measures

Primary Outcomes (2)

• Fatigue - the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ)

  Fatigue is measured through the Danish and Swedish versions of the questionnaire the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ). The BRAF-MDQ covers four subscales assessing physical fatigue, emotional fatigue, cognitive fatigue, and the impact of living with fatigue, which are scored individually and summed to reach a total fatigue score ranging from 0-70, with higher scores indicating more severe fatigue.

  At Baseline, and 3, 6, and 12-month follow-up

• Fatigue - the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF-NRS v2)

  Fatigue is measured through the Danish and Swedish versions of the questionnaire the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF-NRS v2) for fatigue level (severity), effect on life (impact), and coping. BRAF-NRS v2s three separate numerical rating scales are scored from 0-10, and for severity and impact 10 represents worse level or impact of fatigue, where for coping 10 is better at coping).

  At Baseline, and 3, 6, and 12-month follow-up

Secondary Outcomes (12)

• Physical activity - objectively measured

  Baseline and at 6-month follow-up

• Physical activity - Diary

  Baseline and at 6-month follow-up

• Physical activity - Physical fitness test

  Baseline

• Physical activity - Patient-reported

  At Baseline, and 3, 6, and 12-month follow-up

• Health-related quality of life

  At Baseline, and 3, 6, and 12-month follow-up

Other Outcomes (3)

• Disease activity for patients with RA

  Baseline

• Disease activity for patients with SpA and PsA

  Baseline

• Supplementary question regarding sleep duration

  At Baseline, and 3, 6 and 12 months follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

The COMFI intervention

Behavioral: COMFI - a COMbined Fatigue Intervention

Interventions

COMFI - a COMbined Fatigue Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.
• Must have experienced fatigue as a challenge for at least the last 3 months
• A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis
• 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.
• Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.
• Age ≥18 years.
• Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter.
• The participant must be interested in actively participating and making changes to daily life to improve their condition.

You may not qualify if:

• Pregnant or breastfeeding
• 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
• 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
• 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
• Conditions that may be the primary cause of fatigue:

Sponsors & Collaborators

• The Danish Center for Expertise in Rheumatology: lead
• Skaane University Hospital: collaborator
• Odense Patient Data Explorative Network: collaborator
• The Danish Rheumatism Association: collaborator
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator
• Bristol Royal Infirmary: collaborator

Study Sites (2)

The Danish Hospital for Rheumatic Diseases

Sønderborg, Denmark, 6400, Denmark

COMPLETED

Skåne University Hospital

Lund, Sweden, Sweden

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Arthritis; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jette Primdahl, Professor

  The Danish Center for Expertise in Rheumatology

  STUDY DIRECTOR

Central Study Contacts

Astrid J Damgaard, PhD-student

CONTACT

0045 7365 4094; adamgaard@danskgigthospital.dk

Jette Primdahl, Professor

CONTACT

0045 2420 6692; jprimdahl@danskgigthospital.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: It is not possible to blind the intervention to the participants and the healthcare professionals in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in rheumatology rehabilitation

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 30, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); SE (1)