inflammatory myopathy myositis
Conditions
Interventions
Participants will be randomized (ratio 1:1) to the intervention group,
receiving 6-months personalized rehabilitation therapy including either CBT or
ET, or both, or a control group, receiving usual
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=18 and =12 months from diagnosis • Severe fatigue as assessed by a score of >=35 on the subscale fatigue of the Checklist Individual Strength (CIS-Fatigue)
Exclusion criteria
Exclusion criteria: • Unstable disease/evidence of disease activity as assessed by increase in dosage of immunosuppressant/modulating therapy/therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the change in daily functioning from baseline to directly post-intervention, as assessed by the performance score of the Canadian Occupational Performance Measure (COPM). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Daily functioning - satisfaction Assessed with the satisfaction score of the Canadian Occupational Performance Measure (COPM). -Fatigue Assessed with the Checklist Individual Strength (CIS), subscale fatigue. -Physical fitness For physical fitness we will determine the maximal oxygen uptake as assessed through cardiopulmonary exercise testing. -Daily activity Measured through synchronous heart rate monitoring and accelerometry during 7 consecutive days, to establish the total time spent in low, moderate and vigorous intensity activities. Subjects will also be asked to keep an activity diary. -Disability Assessed with the Health Assessment Questionnaire. -Quality of life Assessed with the EQ-5D-5L questionnaire. -Anxiety and depression Assessed with the Hospital Anxiety and Depression Scale (HADS) -Societal costs We assess costs from a societal perspective meaning that we include all costs regardless of who pays for them. Societal costs include: healthcare costs (e.g., hospital admissions, medication use, general practitioner visits); patient and family costs (e.g. informal care); and lost productivity costs (absenteeism from paid and unpaid work, presenteeism related to paid work). Costs of the personalized rehabilitation therapy will be estimated using a bottom-up micro-costing approach in which each component of the therapy will be estimated and valued in Euros. | — |
Countries
Netherlands
Outcome results
None listed