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

CompletedNot a drug-phase studyMS (type not specified)NCT03458767

What it found

No results found

We found no results in the registry or in papers.

This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Eight weekly 90-minute group educational sessions

What it measured

Main measures

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

    Baseline and 8-weeks (post intervention)

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

    Baseline and 8-weeks (post intervention)

    Thinking and memory
  • Change from Baseline NIH Toolbox Flanker Inhibitory Control and Attention Test at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

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

    Baseline and 8-weeks (post intervention)

    Thinking and memory
  • Change from Baseline NIH Toolbox List Sorting Working Memory Test at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Thinking and memory
  • Change from Baseline NIH Toolbox Oral Symbol Digit Test at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Thinking and memory
  • Change from Baseline NIH Toolbox Pattern Comparison Processing Speed Test at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Thinking and memory
  • Change from Baseline NIH Toolbox Picture Sequence Memory Test at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Thinking and memory

Other measures (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)

    Safety
  • 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)

    Mood and sleep
  • 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)

    Physical functionBladder, bowel and sexual function
  • 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)

    Thinking and memoryQuality of life (reported by participants)
  • Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Thinking and memoryMood and sleepQuality of life (reported by participants)
  • Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    FatigueQuality of life (reported by participants)
  • Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Walking and mobilityMood and sleepQuality of life (reported by participants)
  • Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Physical function
  • Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)

    Baseline and 8-weeks (post intervention)

    Physical function

Who could take part

MS (type not specified) · 21 to 70

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Oct 2017

    2. Main results due

      Jun 2018

    3. Finished

      Jun 2018

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