Clinical trial NCT03458767: A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology
Official title: A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Cognitive function
Physical activity
Self-management
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change from Baseline NIH Toolbox Picture Vocabulary Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox Flanker Inhibitory Control and Attention Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox Dimensional Change Card Sort Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox List Sorting Working Memory Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox Oral Symbol Digit Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox Pattern Comparison Processing Speed Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline NIH Toolbox Picture Sequence Memory Test at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
Secondary outcomes:
measure: Change from Baseline Multiple Sclerosis Self-Management Scale (MSSM) at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Medications and Treatments 4a at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Neuro-Quality of Life (QoL) Short Form v2.0 - Cognitive Function at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Sleep quality - sleep latency at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Sleep quality - wake after sleep onset at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Sleep quality - total sleep time at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
measure: Change from Baseline Sleep quality - sleep efficiency at 8-weeks (post-intervention)
timeFrame: Baseline and 8-weeks (post intervention)
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Janet D Morrison, PhD
role: PRINCIPAL_INVESTIGATOR
References: