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Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Support Program
Physical Activity Program
Physical Activity Plus Fatigue Management Education Program
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Exercise, Self Care, Fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A physician-confirmed diagnosis of MS

Exclusion Criteria:

  • Exercise more than 90 minutes per week
  • Pregnant
  • Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
  • Four or more falls in the past 6 months
  • Be able to walk 25 feet with or without a cane or walker
  • Severe cognitive deficits
  • A condition besides MS that had lead to hospitalization in the past year

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Social Support Program

Physical Activity Program

Physical Activity Plus Fatigue

Arm Description

The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.

The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.

The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program. In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.

Outcomes

Primary Outcome Measures

Changes from baseline in physical activity levels
Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire and accelerometers.

Secondary Outcome Measures

Changes from baseline in fatigue levels
Fatigue will be measured with the Fatigue Impact Scale.
Changes from baseline in quality of life
The SF-12, Multiple Sclerosis Impact Scale, and Community Participation Indicator (CPI) will be administered.

Full Information

First Posted
April 4, 2012
Last Updated
December 16, 2021
Sponsor
Case Western Reserve University
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT01572714
Brief Title
Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis
Official Title
Examining the Effects of Physical Activity Promotion, Fatigue Management Education, and Social Support Using a Telehealth Intervention Approach Among Adults With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to conduct a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals in managing fatigue and increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS). The hypothesis is that a fatigue management plus physical activity intervention will significantly improve fatigue, quality of life, physical function, and community integration.
Detailed Description
The long-term objective of this study is to use a telehealth intervention approach to reduce the devastating effects of the reciprocal relationship between fatigue and inactivity on quality of life and participation in life roles in people with multiple sclerosis (MS). Chronic fatigue and inactivity are common problems in persons with MS, and the reciprocal relationship between fatigue and inactivity may have negative synergistic effects on quality of life and participation in life roles. The proposed study is novel in that it represents a multi-disciplinary effort to merge two promising lines of MS research: fatigue management and PA promotion. The proposed fatigue management plus PA intervention (FM+) will consist of incorporating a modified teleconference version of Packer et al.'s empirically-tested Fatigue Management program with innovative, yet simple approaches to promote lifestyle PA by encouraging goal-setting and self-monitoring with a pedometer. Ambulatory individuals with MS will be recruited and randomized into one of three telehealth interventions: social support intervention, PA-only intervention, and FM+.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Exercise, Self Care, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Support Program
Arm Type
Active Comparator
Arm Description
The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.
Arm Title
Physical Activity Program
Arm Type
Active Comparator
Arm Description
The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
Arm Title
Physical Activity Plus Fatigue
Arm Type
Active Comparator
Arm Description
The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program. In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.
Intervention Type
Behavioral
Intervention Name(s)
Social Support Program
Other Intervention Name(s)
Social support
Intervention Description
The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Program
Other Intervention Name(s)
Physical Activity-only
Intervention Description
The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Plus Fatigue Management Education Program
Other Intervention Name(s)
Physical Activity +
Intervention Description
The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program. In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.
Primary Outcome Measure Information:
Title
Changes from baseline in physical activity levels
Description
Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire and accelerometers.
Time Frame
Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
Secondary Outcome Measure Information:
Title
Changes from baseline in fatigue levels
Description
Fatigue will be measured with the Fatigue Impact Scale.
Time Frame
Each patient will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).
Title
Changes from baseline in quality of life
Description
The SF-12, Multiple Sclerosis Impact Scale, and Community Participation Indicator (CPI) will be administered.
Time Frame
Each patient will be given the questionnaires at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A physician-confirmed diagnosis of MS Exclusion Criteria: Exercise more than 90 minutes per week Pregnant Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible) Four or more falls in the past 6 months Be able to walk 25 feet with or without a cane or walker Severe cognitive deficits A condition besides MS that had lead to hospitalization in the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew A Plow, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33100184
Citation
Plow M, Motl RW, Finlayson M, Bethoux F. Response heterogeneity in a randomized controlled trial of telerehabilitation interventions among adults with multiple sclerosis. J Telemed Telecare. 2022 Oct;28(9):642-652. doi: 10.1177/1357633X20964693. Epub 2020 Oct 25.
Results Reference
derived
PubMed Identifier
31595300
Citation
Plow M, Motl RW, Finlayson M, Bethoux F. Intervention Mediators in a Randomized Controlled Trial to Increase Physical Activity and Fatigue Self-management Behaviors Among Adults With Multiple Sclerosis. Ann Behav Med. 2020 Feb 21;54(3):213-221. doi: 10.1093/abm/kaz033.
Results Reference
derived
PubMed Identifier
31229528
Citation
Plow M, Finlayson M, Liu J, Motl RW, Bethoux F, Sattar A. Randomized Controlled Trial of a Telephone-Delivered Physical Activity and Fatigue Self-management Interventions in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2019 Nov;100(11):2006-2014. doi: 10.1016/j.apmr.2019.04.022. Epub 2019 Jun 21.
Results Reference
derived
PubMed Identifier
23072517
Citation
Plow M, Finlayson M, Motl RW, Bethoux F. Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol. BMC Neurol. 2012 Oct 16;12:122. doi: 10.1186/1471-2377-12-122.
Results Reference
derived

Learn more about this trial

Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis

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