Telehealth-Based Exercise Program to Treat Fatigue in MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Brief telephone-based counseling; Other: Education counseling

• Registration Number: NCT01198977
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

Detailed Description

This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Primary Completion: 2015-09
• Results First Submitted: 2016-08-09
• Results First Submitted QC: 2016-08-09
• Results First Posted: 2016-08-12
• Study Completion: 2016-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Multiple Sclerosis
• Veteran receiving services in VA VISN 20
• Fatigue
• Ability to ambulate
• cell phone or Household phone line
• Individual with multiple sclerosis verified by MS provider
• ambulatory

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Exclusion Criteria

• Current alcohol dependence or other substance dependence
• No working phone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief telephone-based counseling	Brief telephone-based counseling	Telephone based counseling and instructional video
Education Counseling	Education counseling	Mailed Physical Activity information and instructional video only

Primary Outcome Measures

Name	Time	Method
Fatigue	baseline, 3 months, 6 months	Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.

Secondary Outcome Measures

Name	Time	Method
Depression	baseline, 3 months, 6 months	Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).; Total Score for 9 items = 27.

Trial Locations

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States