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Completed

NCT Number: NCT03458767

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78701, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  1. Change from Baseline Multiple Sclerosis Self-Management Scale (MSSM) at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    A 24-item self-report instrument developed specifically to address self-management in persons with MS.

  2. Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Medications and Treatments 4a at 8-weeks (post-intervention)

    Time frame: Baseline and 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.

  3. Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a at 8-weeks (post-intervention)

    Time frame: Baseline and 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.

  4. Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a at 8-weeks (post-intervention)

    Time frame: Baseline and 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).

  5. Change from Baseline Neuro-Quality of Life (QoL) Short Form v2.0 - Cognitive Function at 8-weeks (post-intervention)

    Time frame: Baseline and 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.

  6. Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)

    Time frame: Baseline and 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.

  7. Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)

    Time frame: Baseline and 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.

  8. Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)

    Time frame: Baseline and 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.

  9. Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    Accelerometer step count

  10. Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    Accelerometer activity count

  11. Change from Baseline Sleep quality - sleep latency at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    Accelerometer sleep latency

  12. Change from Baseline Sleep quality - wake after sleep onset at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    Accelerometer wake after sleep onset

  13. Change from Baseline Sleep quality - total sleep time at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    Accelerometer total sleep time

  14. Change from Baseline Sleep quality - sleep efficiency at 8-weeks (post-intervention)

    Time frame: Baseline and 8-weeks (post intervention)

    Accelerometer sleep efficiency

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Acronym: PALMS-II

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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