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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Eight weekly 90-minute group educational sessions

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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Eight weekly 90-minute group educational sessions, originally developed for the MAPSS-MS intervention, adapted for remote web-based delivery.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Multiple Sclerosis Self-Management Scale (MSSM) at 8-weeks (post-intervention)	A 24-item self-report instrument developed specifically to address self-management in persons with MS.	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)	A 4-item self-report measure of confidence in managing medication schedules of different complexity. Items also assess managing medication and other treatments in challenging situations such as when traveling, when running out of medication, and when adverse effects are encountered.	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)	A 4-item self-report measure of confidence to manage/control symptoms, to manage symptoms in different settings (home, public place, an unfamiliar place) and to keep symptoms from interfering with work, sleep, relationships or recreational activities.	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)	A 4-item self-report measure of confidence in performing various activities of daily living (ADLs) without assistance. Items also assess exercise, sexual activities and managing activities in challenging situations (traveling, bad weather).	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)	An 8-item self-report measure of mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions.	Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)	An 8-item self-report measure of negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included, which eliminates consideration of these items' confounding effects when assessing patients with comorbid physical conditions. Assesses depression over the past seven days.	Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)	An 8-item self-report measure of fatigue symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Assesses fatigue over the past seven days.	Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)	An 8-item self-report measure of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep). Assesses sleep disturbance over the past seven days.	Baseline and 8-weeks (post intervention)
Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)	Accelerometer step count	Baseline and 8-weeks (post intervention)
Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)	Accelerometer activity count	Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - sleep latency at 8-weeks (post-intervention)	Accelerometer sleep latency	Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - wake after sleep onset at 8-weeks (post-intervention)	Accelerometer wake after sleep onset	Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - total sleep time at 8-weeks (post-intervention)	Accelerometer total sleep time	Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - sleep efficiency at 8-weeks (post-intervention)	Accelerometer sleep efficiency	Baseline and 8-weeks (post intervention)

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Janet D Morrison, PhD, The University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Physical activity; Cognitive function; Self-management
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2017-08-0062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data from this pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No