Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis

Case Western Reserve University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Physical Activity Program; Behavioral: Social Support Program; Behavioral: Physical Activity Plus Fatigue Management Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01572714

03-14-19

Details and patient eligibility

About

The objective of this study is to conduct a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals in managing fatigue and increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS). The hypothesis is that a fatigue management plus physical activity intervention will significantly improve fatigue, quality of life, physical function, and community integration.

Full description

The long-term objective of this study is to use a telehealth intervention approach to reduce the devastating effects of the reciprocal relationship between fatigue and inactivity on quality of life and participation in life roles in people with multiple sclerosis (MS). Chronic fatigue and inactivity are common problems in persons with MS, and the reciprocal relationship between fatigue and inactivity may have negative synergistic effects on quality of life and participation in life roles. The proposed study is novel in that it represents a multi-disciplinary effort to merge two promising lines of MS research: fatigue management and PA promotion. The proposed fatigue management plus PA intervention (FM+) will consist of incorporating a modified teleconference version of Packer et al.'s empirically-tested Fatigue Management program with innovative, yet simple approaches to promote lifestyle PA by encouraging goal-setting and self-monitoring with a pedometer. Ambulatory individuals with MS will be recruited and randomized into one of three telehealth interventions: social support intervention, PA-only intervention, and FM+.

Enrollment: 208 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A physician-confirmed diagnosis of MS

Exclusion criteria

• Exercise more than 90 minutes per week
• Pregnant
• Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
• Four or more falls in the past 6 months
• Be able to walk 25 feet with or without a cane or walker
• Severe cognitive deficits
• A condition besides MS that had lead to hospitalization in the past year

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 3 patient groups

Social Support Program

Active Comparator group

Description:

The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.

Treatment:

Behavioral: Social Support Program

Physical Activity Program

Active Comparator group

Description:

The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.

Treatment:

Behavioral: Physical Activity Program

Physical Activity Plus Fatigue

Active Comparator group

Description:

The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program. In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.

Treatment:

Behavioral: Physical Activity Plus Fatigue Management Education Program