Telehealth-Based Exercise Program to Treat Fatigue in MS

NCT ID: NCT01198977

Last Updated: 2019-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-12-31

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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Brief telephone-based counseling

Telephone based counseling and instructional video

Group Type ACTIVE_COMPARATOR

Brief telephone-based counseling

Intervention Type BEHAVIORAL

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

Education Counseling

Mailed Physical Activity information and instructional video only

Group Type PLACEBO_COMPARATOR

Education counseling

Intervention Type OTHER

Mailed informational video of exercise programs

Interventions

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Brief telephone-based counseling

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

Intervention Type BEHAVIORAL

Education counseling

Mailed informational video of exercise programs

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron P Turner, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26913621 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31097413 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.va.gov/MS

VA Multiple Sclerosis Centers of Excellence web page

Other Identifiers

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B4972-W

Identifier Type: -

Identifier Source: org_study_id

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