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

NCT03458767 | Completed

• 1 other identifier: 2017-08-0062
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Cognitive function; Physical activity; Self-management

Outcome Measures

Primary Outcomes (8)

• Change from Baseline NIH Toolbox Picture Vocabulary Test at 8-weeks (post-intervention)

  Test of vocabulary knowledge

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)

  Test of oral reading (decoding) skills

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox Flanker Inhibitory Control and Attention Test at 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.

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox Dimensional Change Card Sort Test at 8-weeks (post-intervention)

  Test of attention - the allocation of one's limited capacities to deal with an abundance of environmental stimulation) test.

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox List Sorting Working Memory Test at 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.

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox Oral Symbol Digit Test at 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.

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox Pattern Comparison Processing Speed Test at 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.

  Baseline and 8-weeks (post intervention)

• Change from Baseline NIH Toolbox Picture Sequence Memory Test at 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.

  Baseline and 8-weeks (post intervention)

Secondary Outcomes (14)

• 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 Medications and Treatments 4a 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-Quality of Life (QoL) Short Form v2.0 - Cognitive Function at 8-weeks (post-intervention)

  Baseline and 8-weeks (post intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Eight weekly 90-minute group educational sessions

Control group

NO INTERVENTION

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).

Interventions

Eight weekly 90-minute group educational sessions BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Janet D Morrison, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A trained research assistant, blinded to the participant's group assignment, will collect the NIH Toolbox measures using an iPad at baseline and 8-weeks (post-intervention).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot feasibility study employs a mixed methods design conducted in a community setting. Phase 1 uses a single-group qualitative design involving a convenience sample of 5 adults with MS; Phase 2 uses a randomized controlled trial (RCT) design conducted with a sample of 20 adults with MS (10 intervention/10 control). Phase 2 data will be collected at baseline (before the intervention) and at 8-weeks (post-intervention). Data includes self-report measures, an objective measure of physical activity, and neurocognitive tests. An "enhanced usual care" control group is selected as most appropriate for this pilot feasibility study of a non-pharmacologic, behavioral intervention.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: March 8, 2018
• Study Start: October 9, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)