Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis
| Tracking Information | |||||
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| First Received Date ICMJE | April 4, 2012 | ||||
| Last Updated Date | April 4, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis | ||||
| Official Title ICMJE | Examining the Effects of Physical Activity Promotion, Fatigue Management Education, and Social Support Using a Telehealth Intervention Approach Among Adults With Multiple Sclerosis | ||||
| 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. |
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| 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+. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 215 | ||||
| Estimated Completion Date | July 2014 | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01572714 | ||||
| Other Study ID Numbers ICMJE | 11-844 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Matthew Plow, The Cleveland Clinic | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | National Multiple Sclerosis Society | ||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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