Promoting Independence With Compensatory Cognitive Rehabilitation: A Pilot Clinical Trial for Early-Stage Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Changes in Memory Based Everyday Function
研究概览
简要总结
Alzheimer's disease (AD) is one of the leading causes of disability in older adults. Because pharmacological approaches do not seem to prevent or slow the disease, clinicians need non-pharmacological interventions that might help people with AD remain independent for as long as possible. This study aims to evaluate the effects of a new behavioral treatment, the Structured External Memory Aid Treatment (SEMAT), for adults with mild cognitive impairment (MCI) designed to promote independent living skills by explicitly teaching the use of strategies and tools to compensate for cognitive weaknesses.
Aim 1: Evaluate the efficacy of the SEMAT for improving functional performance in a pilot randomized trial.
Aim 2: Evaluate demographic, clinical, and neuropsychological predictors of treatment adherence.
Aim 3: Develop and refine the SEMAT manual and other materials for training future interventionists.
详细描述
Clinical Trial Study Design: Pilot Individually Randomized Group-Treatment Trial
Study Site: University of Delaware. All research activities will occur via telehealth.
Study Participants: Approximately 65 older adults will be recruited to participate to ensure 50 completers with MCI. Participants will be recruited and complete study procedures in waves.
Randomization: Following the screening criteria session and informed consent, if the participant met the criteria for amnestic MCI he/she will be randomly assigned to the immediate treatment or delayed treatment control condition.
Study Procedures Aim 1: Clinical Trial. Once randomly assigned to a condition, participants will complete baseline testing and additional testing at two other time periods: weeks 8 and 16. Participants in the immediate treatment condition will then complete 7-weeks of the group SEMAT. At week 8, participants in both groups will complete assessments. Then, those in the delayed treatment group will complete 7-weeks of treatment. At week 16, participants in both conditions will complete assessments. During assessment sessions, participants will complete performance-based and self-reported measures of independent daily tasks and tests of thinking and memory independently with an assessor for approximately 1 hour. During treatment sessions (approximately 60 minutes), participants will interact with group-mates and learn how use three different categories of external memory aids. Treatment sessions will be video recorded and transcribed.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60-90 years of age
- •English Speaking
- •Functional Vision and Hearing to Complete Phone Screen
- •not taking or stable ( >2 months) on nootropic meds
- •amnestic mild cognitive impairment from probable Alzheimer's disease
排除标准
- •History of major psychiatric disorder (e.g. schizophrenia)
- •Untreated major depression
- •History of medical diseases that are related to cognitive impairment
- •current participation in another clinical trial related to memory
- •major auditory, visual, or motor impairment that would affect their ability to participate in the study
- •substance use disorder in the past 5 years
研究组 & 干预措施
Immediate Treatment Group
Participants will complete 7, 60-minute SEMAT sessions over 7 weeks with their group.
干预措施: Structured External Memory Aid Treatment (SEMAT) (Behavioral)
Delayed Treatment Control
Participants will not receive the intervention immediately. After 8 weeks, participants in this arm will complete the SEMAT. This is not a crossover design, because the treatment effects from those in the immediate treatment group can not be taken away.
结局指标
主要结局
Changes in Memory Based Everyday Function
时间窗: Baseline to immediately post-treatment
The Everyday Cognition (ECog) is a questionnaire to assess improvements in memory based everyday functioning. The ECog comprises of 39 items on which the participant's current level of everyday functioning is compared to a pervious level. Items are rated on a four-point scale: 1= better or no change; 4= consistently much worse. Higher scores indicate greater functional limitations. The self-report and informant versions will be administered.
Changes in Memory Based Compensation
时间窗: Baseline to immediately post-treatment
Everyday Compensation (EComp) is a questionnaire to assess improvements in memory based compensation. The EComp comprises of 41 items on which the participant's current level of strategy use is compared to a pervious level. Items are rated on a four-point scale: 1= never; 4= always. Higher scores indicate greater strategy use. The self-report and informant versions will be administered.
次要结局
- Changes in Everyday Strategy Use(Baseline to immediately post-treatment)
- Maintained Changes in Memory Based Everyday Function(Immediately post-treatment to 8-weeks later)
- Changes in Quality of Life(Baseline to immediately post-treatment)
- Changes in Executive Functioning Skills(Baseline to immediately post-treatment)
- Changes in Cognitive Abilities(Baseline to immediately post-treatment)
- Changes in Self Efficacy(Baseline to immediately post-treatment)
- Maintained Changes in Memory Based Compensation(Immediately post-treatment to 8-weeks later)
- Maintained Changes in Everyday Strategy Use(Immediately post-treatment to 8-weeks later)