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

Browse trials for

• Multiple Sclerosis 3,452
• Sclerosis 3,139

Keywords

• Cognitive function
• Physical activity
• Self-management

Study arms

• 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

• 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).

Interventions

• BehavioralEight 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.

Primary outcomes

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

   Test of vocabulary knowledge

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

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

   Test of oral reading (decoding) skills

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

3. 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.

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

4. 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.

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

5. 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.

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

6. 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.

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

7. 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.

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

8. 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.

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

Secondary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

4. 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).

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

5. 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.

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

6. 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.

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

7. 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.

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

8. 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.

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

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

   Accelerometer step count

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

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

    Accelerometer activity count

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

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

    Accelerometer sleep latency

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

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

    Accelerometer wake after sleep onset

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

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

    Accelerometer total sleep time

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

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

    Accelerometer sleep efficiency

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

Study documents

• Study protocol · Sep 19, 2017
• Statistical analysis plan · Sep 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no plan to share individual participant data from this pilot study