A Pilot Randomized Controlled Trial of a Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) (CoINTEGRATE- for Foreign-Born Arab Americans- a Dyadic Approach)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Overall experience based qualitative semi-structured interview
研究概览
简要总结
The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. This study will evaluate the feasibility of a cognitive and affective intervention combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with Mild Cognitive Impairment (MCI) or those with cognitive complaints.
The study team hypothesizes that combining evidence-based cognitive and affective therapies (CRT+CBT) with lifestyle modifications is feasible and will improve the cognitive performance and Quality of Life (QoL) in patients with MCI and participants caregivers compared to usual care.
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)
盲法说明
Only the data collectors in this study will be blind to the dyad's allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall experience based qualitative semi-structured interview
时间窗: Week 9 (after treatment ended)
This interview will be conducted at the end of the study and in the order of exit of participants to gather feedback about their satisfaction with the study. This brief interview consists of 3 questions that ask the participants to describe the aspects of the intervention participants found beneficial, willingness to participate again, and whether it was appropriate for participants needs. In addition, a brief quantitative satisfaction survey to rate overall satisfaction, how likely it would be recommend to others, and how satisfied participants are with telemedicine as a mode of delivery.
Number of patients that complete the study
时间窗: week 8 (end of treatment)
Average number of sessions completed
时间窗: week 8 (end of treatment)
次要结局
- The Memory Complaint Scale (MCS-2 minute) score(Week 9 (after treatment ended))
- Brief Visuospatial Memory test (BVMT-R-25 minutes)(Week 9 (after treatment ended))
- The Short Form Health Survey (SF-36)(Week 9 (after treatment ended))
- The Symbol Digit Modalities Test Score (SDMT-5 minutes)(Week 9 (after treatment ended))
- Arabic Verbal Memory Test (VMAT)(Week 9 (after treatment ended))
- California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)(Week 9 (after treatment ended))
研究者
Hala Darwish
Associate Professor of Nursing
University of Michigan