Telehealth-Based Exercise Program to Treat Fatigue in MS

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

Detailed Description
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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.

Official Title
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Telehealth-Based Exercise Program to Treat Fatigue in MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Brief telephone-based counseling
* Other: Education counseling


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Current alcohol dependence or other substance dependence No working phone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief telephone-based counseling<br>Telephone based counseling and instructional video | Behavioral: Brief telephone-based counseling<br>* Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving<br>|
| Placebo Comparator: Education Counseling<br>Mailed Physical Activity information and instructional video only | Other: Education counseling<br>* Mailed informational video of exercise programs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | 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. | baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 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. | baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, Fatigue, exercise, telemedicine, motivational interviewing, counseling, depression, physical activity