Multiple Sclerosis Clinical Trial

A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology

Summary

Development and pilot testing of a cognitive self-management intervention for persons with multiple sclerosis (PwMS) emphasizing physical activity (PA) delivered via web-based video conference.

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Full Description

The primary objective of this study is to develop and pilot test an innovative cognitive self-management intervention for PwMS delivered via web-based video conferencing. Data derived from interviews will be used to guide the adaptation of Stuifbergen's 8-week Memory, Attention, and Problem-Solving Skills in MS (MAPSS-MS) intervention to be delivered via web-based video conferencing. The adapted MAPSS-MS intervention will be feasibility tested in small groups of PwMS. Outcome variables include: (1) neurocognitive function assessed using the NIH Toolbox®, a comprehensive set of psychometrically sound neuro-behavioral measures that quickly assesses cognitive functions using an iPad, (2) objective PA and sleep using Actigraph™ accelerometers, (3) self-reported sleep, depression, and fatigue using the Patient-Reported Outcome Measurement Information System (PROMIS), and (4) MS specific self-management using the Multiple Sclerosis Self-Management Scale (MSSM). Community-residing PwMS, age 21 to 70, will be recruited from Central Texas to participate in Phase 1 interviews (n=5) and Phase 2 pilot testing (n=20) of the adapted version of the 8-week MAPSS-MS cognitive self-management intervention emphasizing PA delivered via web-based video conferencing. In Phase 2 pilot testing (n=20), an intervention group (n=10) will be compared to an "enhanced usual care" control group (n=10).

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Eligibility Criteria

Inclusion Criteria:

Diagnosis of clinically definite MS documented by their healthcare provider
Age 21 to 70
Capable of understanding and complying with the study protocol
Able to read and write in English
Stable disease at the time of entry into the study (relapse free for at least 90 days)
Willing to participate in an 8-week study promoting physical activity, MS self-management and compensatory cognitive strategies, and data collection
Have subjective concerns about their cognitive functioning (score ≥ 10 on the 20-item Perceived Deficits Questionnaire)
Any gender
Any ethnic/racial group

Exclusion Criteria:

Currently pregnant or plan to be
Diagnosed with cardiovascular or respiratory disease, other medical causes of dementia or other neurological disorders that may impact cognition or emotions
Evidence of major psychiatric disorder
Major functional limitations that preclude them from participating in the study

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

16

Study ID:

NCT03458767

Recruitment Status:

Completed

Sponsor:

University of Texas at Austin

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There is 1 Location for this study

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The University of Texas at Austin
Austin Texas, 78701, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

16

Study ID:

NCT03458767

Recruitment Status:

Completed

Sponsor:


University of Texas at Austin

How clear is this clinincal trial information?

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