To answer the following questions; (1) What is the estimated effect size of personalized rehabilitation therapy for improving daily functioning in severely fatigued myositis patients, compared to usual care? (2) What are the societal costs of…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
-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.
Background summary
Myositis is the most prevalent acquired muscle disorder in adults and affects
100.000 people in Europe. Despite an initial favorable effect of
immunosuppressive treatment most people suffer from long-standing disability.
Severe fatigue is highly prevalent (70-90%) during this chronic phase, leading
to decreased daily functioning, participation and quality of life. Disease
related costs are 3 to 5 times higher than in the general population, with a
significant contribution attributable to indirect costs. This warrants
development of interventions to improve function and return-to-work. Cognitive
behavioral therapy (CBT) and Exercise Therapy (ET) are promising rehabilitation
interventions that have shown to be effective in muscular dystrophies.
Personalized rehabilitation therapy, including remotely delivered CBT, ET, or
both is likely to be (cost)effective compared to usual care in the chronic
phase of myositis. A pilot study is first needed to estimate the effect size of
the intervention.
Study objective
To answer the following questions; (1) What is the estimated effect size of
personalized rehabilitation therapy for improving daily functioning in severely
fatigued myositis patients, compared to usual care? (2) What are the societal
costs of personalized rehabilitation therapy compared to usual care amongst
severely fatigued myositis patients?
Study design
A multicenter, assessor-blinded, pilot randomized controlled trial.
Intervention
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 care.
Study burden and risks
All participants will be asked to visit the Amsterdam UMC, location AMC at 3
times over the study period of 6 months. The first visit is the screening visit
with an estimated duration of 1 hour, to: fill out the CIS-Fatigue
questionnaire and to participate in a physical examination (including resting
ECG). The second (T0, baseline) and third visit (T1, directly
post-intervention) are the assessment visits with an estimated duration on 2
hours each, for: assessment of the COPM, filling out the other study
questionnaires, and conduction of the maximal exercise test. The total duration
of all procedures is estimated at 5 hours (excluding travel time).
Additionally, all patients will be asked to wear a heart rate monitor and
accelerometer for 7 consecutive days following the 2 assessment visits (T0 and
T1). For participants allocated to the intervention group there is an
additional time investment (see intervention section). There will be
pre-cautions to minimize potential risks related to the intervention, including
a screening procedure to ensure safety of physical exercise and clear
instructions on when to stop exercising. The participating centers are well
experienced in providing ET and CBT in people with IIM. Therefore, the
occurrence of medical events is anticipated to be minimal. Considering the
positive effects of ET and CBT known from preliminary research it can be
concluded that the benefits outweigh the burden and minimal risk associated
with this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• Age >=18 and <68 years
• Idiopathic inflammatory myopathy according to EULAR/ACR criteria, except
inclusion body myositis
• Disease duration >=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
• Unstable disease/evidence of disease activity as assessed by increase in
dosage of immunosuppressant/modulating therapy/therapies < 3 months
• Co-morbidity interfering with the intervention or influencing outcomes, e.g.
severe anaemia, abnormalities in thyroid function, or contraindications for
being physically active according to the guidelines by the American College of
Sports Medicine
• Unable to complete study questionnaires or interventions
• Participation in another trial interfering with the intervention or
influencing outcomes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84987.018.23 |