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

NCT ID: NCT03458767

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2018-06-01

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Eight weekly 90-minute group educational sessions

Intervention Type: BEHAVIORAL

Eight weekly 90-minute group educational sessions, originally developed for the MAPSS-MS intervention, adapted for remote web-based delivery.

Control group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Eight weekly 90-minute group educational sessions

Eight weekly 90-minute group educational sessions, originally developed for the MAPSS-MS intervention, adapted for remote web-based delivery.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet D Morrison, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-08-0062

Identifier Type: -

Identifier Source: org_study_id