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NCT Number: NCT01572714

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

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+.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Support Program

Behavioral

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.

Other names: Social support

Physical Activity Program

Behavioral

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.

Other names: Physical Activity-only

Physical Activity Plus Fatigue Management Education Program

Behavioral

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.

Other names: Physical Activity +

Primary outcomes

  1. Changes from baseline in physical activity levels

    Time frame: Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).

    Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire and accelerometers.

Secondary outcomes

  1. Changes from baseline in fatigue levels

    Time frame: Each patient will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).

    Fatigue will be measured with the Fatigue Impact Scale.

  2. Changes from baseline in quality of life

    Time frame: Each patient will be given the questionnaires at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).

    The SF-12, Multiple Sclerosis Impact Scale, and Community Participation Indicator (CPI) will be administered.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

Examining the Effects of Physical Activity Promotion, Fatigue Management Education, and Social Support Using a Telehealth Intervention Approach Among Adults With Multiple Sclerosis

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2012
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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