Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Memory for Intentions Test Total Score Percentile
研究概览
简要总结
Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial.
The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of MS
- •Able to read, write, and speak in English
- •Between the ages of 18 and 60
- •All genders
- •No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse
- •No relapses within the past two months
- •Access to the Internet and a web camera
- •Not enrolled in a cognitive rehabilitation program within the past six months
- •Self-reported issues "remembering places they have to be" and "things they have to do"
排除标准
- •No diagnosis of MS
- •Unable to complete the study protocol due to language barriers
- •Younger than 18 or older than 61
- •No gender exclusions
- •History of other serious neurologic or psychiatric illness, including drug or alcohol misuse
- •Had a relapse within the past two months
- •No access to the Internet and/or a web camera
- •Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months
- •No self-reported issues with "remembering places they have to be" or "things they have to do"
结局指标
主要结局
Memory for Intentions Test Total Score Percentile
时间窗: Six weeks
Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from \<1 9 (coded as 0 for analyses) to \>99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.
Memory for Intentions Test Time Cue Subscale Percentile
时间窗: Six weeks
Performance on objective prospective memory (time-based)
次要结局
- Perceived Deficits Questionnaire-Prospective Memory Subscale(Six weeks)