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.
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.
Pregnant or breastfeeding
Diseases with an expected survival of < 2 years (e.g., cancer)
Heart failure with NYHA class 3 or 4
Kidney failure with eGFR < 30
Single group
COMFI - a COMbined Fatigue Intervention
BehavioralThe 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.
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.
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).
Physical activity - objectively measured
Physical activity will be objectively measured through an accelerometer from SENS motion. The participants will wear an accelerometer for 7 days before starting the intervention and before participating in session 7.
Physical activity - Diary
The accelerometer will be combined with a diary tracking sleep, movement/work, and sedentary time to further qualify the results from the accelerometer.
Physical activity - Physical fitness test
Participants will perform the Aastrand bike sub-maximal physical fitness test (aerobic capacity).
Physical activity - Patient-reported
Physical activity will be measured through the questionnaire International Physical Activity Questionnaire (IPAQ), which enables the calculations of MET.
Disease activity for patients with RA
The DAS28-CRP is a measure of disease activity in RA; assessing 28 specified joints, serum inflammatory markers, and a visual analog scale (0-10) of the patient's global function. A score greater than 5.1 indicates active disease and less than 3.2 indicates well-controlled disease.
Disease activity for patients with SpA and PsA
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The scale ranges from 0-100. The higher the number, the more disease activity.
Supplementary question regarding sleep duration
In the past 4 weeks, how many hours and minutes did you sleep on an average weekday night?
Click on the lead sponsor to view all of their trials.
The Danish Center for Expertise in Rheumatology
Lead sponsor
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
