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Telehealth-Based Exercise Program to Treat Fatigue in MS (MS-FIT)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief telephone-based counseling
Education counseling
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, Fatigue, exercise, telemedicine, motivational interviewing, counseling, depression, physical activity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Brief telephone-based counseling

Education Counseling

Arm Description

Telephone based counseling and instructional video

Mailed Physical Activity information and instructional video only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2010
Last Updated
September 24, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01198977
Brief Title
Telehealth-Based Exercise Program to Treat Fatigue in MS
Acronym
MS-FIT
Official Title
Telehealth-Based Exercise Program to Treat Fatigue in MS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, Fatigue, exercise, telemedicine, motivational interviewing, counseling, depression, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief telephone-based counseling
Arm Type
Active Comparator
Arm Description
Telephone based counseling and instructional video
Arm Title
Education Counseling
Arm Type
Placebo Comparator
Arm Description
Mailed Physical Activity information and instructional video only
Intervention Type
Behavioral
Intervention Name(s)
Brief telephone-based counseling
Intervention Description
Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving
Intervention Type
Other
Intervention Name(s)
Education counseling
Intervention Description
Mailed informational video of exercise programs
Primary Outcome Measure Information:
Title
Fatigue
Description
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 Outcome Measure Information:
Title
Depression
Description
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
Other Pre-specified Outcome Measures:
Title
Physical Activity (Behavioral Target)
Description
First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron P Turner, PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26913621
Citation
Turner AP, Hartoonian N, Sloan AP, Benich M, Kivlahan DR, Hughes C, Hughes AJ, Haselkorn JK. Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. J Consult Clin Psychol. 2016 Apr;84(4):297-309. doi: 10.1037/ccp0000086. Epub 2016 Feb 25.
Results Reference
result
PubMed Identifier
31097413
Citation
Turner AP, Hartoonian N, Hughes AJ, Arewasikporn A, Alschuler KN, Sloan AP, Ehde DM, Haselkorn JK. Physical activity and depression in MS: The mediating role of behavioral activation. Disabil Health J. 2019 Oct;12(4):635-640. doi: 10.1016/j.dhjo.2019.04.004. Epub 2019 Apr 30.
Results Reference
derived
Links:
URL
http://www.va.gov/MS
Description
VA Multiple Sclerosis Centers of Excellence web page

Learn more about this trial

Telehealth-Based Exercise Program to Treat Fatigue in MS

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