Effectiveness and Cost-effectiveness of the Energetic Program

Neuromuscular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208687
• Other study ID #: 2014/077
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: November 6, 2017
• Start date: August 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Behavioral:
• Energetic
Physiotherapy and occupational therapy aimed at reconditioning and social participation.

Other:
• Control group
Usual care

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University	Center of expertise Sneller herstel, Revalidatiefonds Nederland, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

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