A Pilot of Memory Support System for Older Chinese Americans With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The Memory Support System (MSS) from the Healthy Action to Benefit Independence & Thinking® (HABIT) Program is an evidence-based, non-pharmacological intervention for mild cognitive impairment (MCI). Despite the clinical benefits and feasibility, the MSS was primarily developed and used with non-Hispanic White, English-speaking adults. Racial/ethnic minority groups are chronically under-enrolled in clinical trials for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) due to lack of linguistically and culturally appropriate adaptation of assessment measures and intervention protocols. The purpose of this research study is to examine whether the MSS from HABIT can help Chinese American older adults with mild thinking and memory problems. Target recruitment is 60 Chinese American adults who are primarily Mandarin- (n=30) and Cantonese-speaking (n=30). Forty participants will participate in the trainer-led day planner training and 20 will participate in self-study of the day planner and receive brain health education. Each participant will also be asked to identify a study partner to participate with them.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-identify as Chinese American;
- •age 55 and above;
- •a diagnosis of MCI as confirmed through documented clinical assessment and/or research-based diagnostic criteria;
- •predominantly Cantonese- or Mandarin-speaking;
- •able to read and write in Chinese;
- •visual and auditory acuity adequate for cognitive testing;
- •willing to complete the assessment measures;
- •having someone in regular contact to serve as a study partner/informant;
- •absence or stable use of prescribed memory-enhancing medications within the last 3 months.
排除标准
- •any significant neurologic disease that would impact their participation and completion of the trial;
- •history of psychiatry disorder (DSM 5 criteria) within the last 12 months;
- •history of reading or writing disability sufficient to interfere with MSS training; or
- •concurrent participation in another relevant clinical trial.
研究组 & 干预措施
MSS Intervention Group
10-session MSS Training Workbook. Additional sessions beyond the standard 10 sessions can be added up to a maximum of 15 total sessions.
干预措施: Memory Support System (Behavioral)
Brain Health Education Control Group
10 session Brain Health Education. Additional sessions beyond the standard 10 sessions can be added up to a maximum of 15 total sessions.
干预措施: Brain Health Education (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: baseline, week 1 of intervention session
Recruitment rate will be measured by dividing the number of enrollees over the number of total potential participants approached.
Retention rate
时间窗: baseline, treatment end (4-9 weeks)
Retention rate will be measured by dividing the number of enrollees who remain in the study over the total number of enrollees.
Completion rate
时间窗: baseline, treatment end (4-9 weeks)
Completion rate will be measured by dividing the number of enrollees who complete all study procedures over the number of total enrollees.
次要结局
- The Pillbox Test(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Dementia Rating Scale-2 (DRS-2)(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Chronic Disease Self-Efficacy Scales(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Everyday Cognition questionnaire(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Functional Activities Questionnaire (FAQ)(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Quality of Life in Alzheimer Disease(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Neuropsychiatric Inventory Questionnaire (NPI-Q) - Severity(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Center for Epidemiologic Studies Depression Scale(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Anxiety Inventory Form(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Pittsburgh Sleep Quality Index(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
- Caregiver Burden Inventory Short-Form(at baseline, treatment end (4-9 weeks), and 8-week follow-up)
研究者
Clara Li
Associate Professor of Psychiatry
Icahn School of Medicine at Mount Sinai