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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Case Western Reserve University
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Matthew Plow, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01572714
First received: April 4, 2012
Last updated: January 22, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Behavioral: Social Support Program
Behavioral: Physical Activity Program
Behavioral: Physical Activity Plus Fatigue Management Education Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Changes from baseline in physical activity levels [ 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). ] [ Designated as safety issue: No ]
    Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire and accelerometers.


Secondary Outcome Measures:
  • Changes from baseline in fatigue levels [ 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). ] [ Designated as safety issue: No ]
    Fatigue will be measured with the Fatigue Impact Scale.

  • Changes from baseline in quality of life [ 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). ] [ Designated as safety issue: No ]
    The SF-12, Multiple Sclerosis Impact Scale, and Community Participation Indicator (CPI) will be administered.


Estimated Enrollment: 215
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Social Support Program
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.
Behavioral: Social Support Program
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.
Other Name: Social support
Active Comparator: Physical Activity Program
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.
Behavioral: Physical Activity Program
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.
Other Name: Physical Activity-only
Active Comparator: Physical Activity Plus Fatigue
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.
Behavioral: Physical Activity Plus Fatigue Management Education 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.
Other Name: Physical Activity +

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+.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572714

Contacts
Contact: Corey McDaniel, BS (216) 368-4879 Corey.McDaniel@UHHospitals.org
Contact: Arielle Tucker, MS (216) 368-0510 Arielle.Tucker@UHHospitals.org

Locations
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Corey McDaniel, BS    216-368-4879    Corey.McDaniel@UHHospitals.org   
Contact: Arielle Tucker, MS    (216) 368-0510    Arielle.Tucker@UHHospitals.org   
Principal Investigator: Matthew A Plow, Ph.D         
Sponsors and Collaborators
Case Western Reserve University
National Multiple Sclerosis Society
Investigators
Principal Investigator: Matthew A Plow, PhD Case Western Reserve University
  More Information

No publications provided by Case Western Reserve University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Plow, Project Scientist, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01572714     History of Changes
Other Study ID Numbers: 03-14-19
Study First Received: April 4, 2012
Last Updated: January 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Exercise
Self Care
Fatigue

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 28, 2015