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

July 13, 2018 updated by: University of Texas at Austin
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 8-weeks (post intervention)
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
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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).
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)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
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.
Baseline and 8-weeks (post intervention)
Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)
Time Frame: Baseline and 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)
Time Frame: Baseline and 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)
Time Frame: Baseline and 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)
Time Frame: Baseline and 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)
Time Frame: Baseline and 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)
Time Frame: Baseline and 8-weeks (post intervention)
Accelerometer sleep efficiency
Baseline and 8-weeks (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janet D Morrison, PhD, The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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