Effectiveness and Cost-effectiveness of the Energetic Program

Study Overview
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Brief Summary
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Fatigue is present in at least 60% of the patients with a muscle disease and can be the most disabling symptom. In combination with other impairments, this often results in low levels of physical activity and decreased social participation, leading to large societal costs. Energetic is a self-management group program aimed at improving participation and physical endurance in these patients. Our hypothesis is that Energetic results in improved participation and improved physical endurance, less experienced fatigue and better quality of life compared to usual care, without increasing health care costs.

Official Title
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Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.

Conditions
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Neuromuscular Diseases

Intervention / Treatment
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* Behavioral: Energetic
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: formal diagnosis of muscular disease, either FascioScapuloHumeral Dystrophy (FSHD), Inclusion Body Myositis (IBM), Mitochondrial Myopathy (MM) or any other; being severely fatigued being cardiopulmonary stable and capable of aerobic training (as determined using a submaximal cycling exercise test with ECG (electrocardiography) and advice from a consultant cardiologist and pulmonologist); being motivated, committed to the program, and 'ready to change' which is discussed with the patient during the screening by a rehabilitation physician and an occupational therapist; to this end, motivational interviewing will be used (including a advantages/disadvantages matrix; a visual analogue scale (VAS) to rate the importance of participation in de program; and a VAS to rate the confidence a patient has that participation in the program is feasible) being able to formulate at least 3 individual participation goals during the interview with the occupational therapist. Exclusion Criteria: active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history, pregnancy, severe co-morbid condition, having participated in the Energetic program before a travel distance perceived as too burdensome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energetic<br>Self management group program aimed at reconditioning and social participation | Behavioral: Energetic<br>* Physiotherapy and occupational therapy aimed at reconditioning and social participation.<br>|
| Other: Control group<br>Usual care | Other: Control group<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure (COPM) | Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 and 12 months (see secondary outcome measures) (patient) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance (patient) | 3 months | 
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance (patient) | 6 months | 
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance (patient) | 15 months | 
| Canadian Occupational Performance Measure (COPM-performance) | Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient) | 6 months | 
| Canadian Occupational Performance Measure (COPM-performance) | Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient) | 15 months | 
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 3 months | 
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 6 months | 
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 15 months | 
| Six Minutes Walking Test (6MWT) | physical endurance, sub-max test. (patient) | 3 months | 
| Six Minutes Walking Test (6MWT) | physical endurance, sub-max test. (patient) | 6 months | 
| Six Minutes Walking Test (6MWT) | physical endurance, sub-max test. (patient) | 15 months | 
| Health care cost | Evaluation health care cost (patient) | 3 months | 
| Health care cost | Evaluation health care cost (patient) | 6 months | 
| Health care cost | Evaluation health care cost (patient) | 15 months | 
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | Impact of fatigue (patient) | 3 months | 
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | Impact of fatigue (patient) | 6 months | 
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | Impact of fatigue (patient) | 15 months | 
| Health-related Quality of Life: Short Form 36 (SF-36) | Quality of life, used for evaluation of cost effectiveness (patient) | 3 months | 
| Health-related Quality of Life: Short Form 36 (SF-36) | Quality of life, used for evaluation of cost effectiveness (patient) | 6 months | 
| Health-related Quality of Life: Short Form 36 (SF-36) | Quality of life, used for evaluation of cost effectiveness (patient) | 15 months | 
| General Self-Efficacy Scale | Evaluation of the perceived self-efficacy (patient) | 3 months | 
| General Self-Efficacy Scale | Evaluation of the perceived self-efficacy (patient) | 6 months | 
| General Self-Efficacy Scale | Evaluation of the perceived self-efficacy (patient) | 15 months | 
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (patient) | 3 months | 
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (patient) | 6 months | 
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (patient) | 15 months | 
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden (caregiver) | 3 months | 
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden (caregiver) | 6 months | 
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden (caregiver) | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Participation, Fatigue, Self-Management, Rehabilitation, Physical therapy, Occupational therapy, Group intervention, Exercise