Effectiveness and Cost-effectiveness of the Energetic Program

Overview

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.

Full Title of Study: “Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2016

Interventions

  • Behavioral: Energetic
    • Physiotherapy and occupational therapy aimed at reconditioning and social participation.
  • Other: Control group
    • Usual care

Arms, Groups and Cohorts

  • Experimental: Energetic
    • Self management group program aimed at reconditioning and social participation
  • Other: Control group
    • Usual care

Clinical Trial Outcome Measures

Primary Measures

  • Canadian Occupational Performance Measure (COPM)
    • Time Frame: 3 months
    • 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)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University Medical Center
  • Collaborator
    • ZonMw: The Netherlands Organisation for Health Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edith Cup, dr., Principal Investigator, Radboudumc, department Rehabilitation

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