Telehealth-Based Exercise Program to Treat Fatigue in MS

N/ACompletedNCT01198977

VA Office of Research and Development64 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Brief telephone-based counselingBEHAVIORAL

Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving

Education counselingOTHER

Mailed informational video of exercise programs

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline, 3 months, 6 months

Secondary Outcomes

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.

Time frame: baseline, 3 months, 6 months

Data from ClinicalTrials.gov

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