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

This study is currently recruiting participants.
Verified April 2012 by The Cleveland Clinic
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Matthew Plow, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01572714
First received: April 4, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted

April 4, 2012
April 4, 2012
July 2011
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis
Examining the Effects of Physical Activity Promotion, Fatigue Management Education, and Social Support Using a Telehealth Intervention Approach Among Adults With Multiple Sclerosis

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.

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+.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Multiple Sclerosis
  • 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
  • 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
  • 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 +
  • 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.
    Intervention: Behavioral: Social Support Program
  • 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.
    Intervention: Behavioral: Physical Activity Program
  • 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.
    Intervention: Behavioral: Physical Activity Plus Fatigue Management Education Program
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
215
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Corey McDaniel, BA (216) 445-9674 mcdanic3@ccf.org
United States
 
NCT01572714
11-844
No
Matthew Plow, The Cleveland Clinic
The Cleveland Clinic
National Multiple Sclerosis Society
Principal Investigator: Matthew A Plow, PhD The Cleveland Clinic
The Cleveland Clinic
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP