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

The University of Texas System (UT)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Eight weekly 90-minute group educational sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03458767

2017-08-0062

Details and patient eligibility

About

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.

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).

Enrollment: 16 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Intervention group

Experimental group

Description:

Eight weekly 90-minute group educational sessions attended via a computer, tablet, or smart phone using a web-based video conference platform.

Treatment:

Behavioral: Eight weekly 90-minute group educational sessions

Control group

No Intervention group

Description:

Enhanced usual care control group will receive an illustrated instructional booklet on Physical Activity for persons with MS developed by the National Center on Health, Physical Activity and Disability (NCHPAD).