A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University of Texas at Austin
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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).
Investigators
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
Outcomes
Primary Outcomes
Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of oral reading (decoding) skills
Change from Baseline NIH Toolbox Picture Vocabulary Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of vocabulary knowledge
Change from Baseline NIH Toolbox Flanker Inhibitory Control and Attention Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of executive function - the capacity to plan, organize and monitor the execution of behaviors that are strategically directed in a goal-oriented manner) and attention (allocation of one's limited capacities to deal with an abundance of environmental stimulation) test.
Change from Baseline NIH Toolbox Dimensional Change Card Sort Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of attention - the allocation of one's limited capacities to deal with an abundance of environmental stimulation) test.
Change from Baseline NIH Toolbox Oral Symbol Digit Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of processing speed - the amount of time it takes to mentally process a set amount of information, or the amount of information that can be processed within a certain unit of time. It is a measure that reflects mental efficiency.
Change from Baseline NIH Toolbox Pattern Comparison Processing Speed Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of processing speed - the amount of time it takes to mentally process a set amount of information, or the amount of information that can be processed within a certain unit of time. It is a measure that reflects mental efficiency.
Change from Baseline NIH Toolbox List Sorting Working Memory Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of working memory - the capacity of an individual to hold information in a short-term buffer and manipulate the information.
Change from Baseline NIH Toolbox Picture Sequence Memory Test at 8-weeks (post-intervention)
Time Frame: Baseline and 8-weeks (post intervention)
Test of episodic memory - the acquisition, storage and retrieval of new information. It involves conscious recollection of information learned within a context.
Secondary Outcomes
- Change from Baseline Multiple Sclerosis Self-Management Scale (MSSM) at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - sleep latency at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - total sleep time at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - sleep efficiency at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Medications and Treatments 4a at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Neuro-Quality of Life (QoL) Short Form v2.0 - Cognitive Function at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - wake after sleep onset at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))