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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572714
• Other study ID #: 03-14-19
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: February 2017

Study information

• Verified date: December 2021
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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+.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Social Support Program
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.
• Physical Activity Program
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.
• Physical Activity Plus Fatigue Management Education Program
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.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in physical activity levels	Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire and accelerometers.	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).
Secondary	Changes from baseline in fatigue levels	Fatigue will be measured with the Fatigue Impact Scale.	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).
Secondary	Changes from baseline in quality of life	The SF-12, Multiple Sclerosis Impact Scale, and Community Participation Indicator (CPI) will be administered.	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).