A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
A trained research assistant, blinded to the participant's group assignment, will collect the NIH Toolbox measures using an iPad at baseline and 8-weeks (post-intervention).
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
Eight weekly 90-minute group educational sessions attended via a computer, tablet, or smart phone using a web-based video conference platform.
干预措施: Eight weekly 90-minute group educational sessions (Behavioral)
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).
结局指标
主要结局
Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)
时间窗: Baseline and 8-weeks (post intervention)
Test of oral reading (decoding) skills
Change from Baseline NIH Toolbox Picture Vocabulary Test at 8-weeks (post-intervention)
时间窗: Baseline and 8-weeks (post intervention)
Test of vocabulary knowledge
Change from Baseline NIH Toolbox Flanker Inhibitory Control and Attention Test at 8-weeks (post-intervention)
时间窗: 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.
Change from Baseline NIH Toolbox Dimensional Change Card Sort Test at 8-weeks (post-intervention)
时间窗: 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.
Change from Baseline NIH Toolbox Oral Symbol Digit Test at 8-weeks (post-intervention)
时间窗: 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.
Change from Baseline NIH Toolbox Pattern Comparison Processing Speed Test at 8-weeks (post-intervention)
时间窗: 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.
Change from Baseline NIH Toolbox List Sorting Working Memory Test at 8-weeks (post-intervention)
时间窗: 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.
Change from Baseline NIH Toolbox Picture Sequence Memory Test at 8-weeks (post-intervention)
时间窗: 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.
次要结局
- 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 Symptoms 4a at 8-weeks (post-intervention)(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)(Baseline and 8-weeks (post intervention))
- Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - sleep latency at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - total sleep time at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - sleep efficiency 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))
- 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))
- Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))
- Change from Baseline Sleep quality - wake after sleep onset at 8-weeks (post-intervention)(Baseline and 8-weeks (post intervention))