Minds Navigating the Diagnosis of Mild Cognitive Impairment (MiND-MCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Feasibility of a group video-telehealth intervention for veterans with MCI
研究概览
简要总结
The goal of this clinical trial is to find out if a 9 week group therapy using video from home will help veterans with Mild Cognitive Impairment (MCI). The main questions it aims to answer are:
- is the video therapy user-friendly for veterans?
- does it improve veterans well-being and quality-of-life?
Veterans will be asked to attend nine 1 hour small group video sessions and will complete questionnaires before and after the sessions.
Researchers will compare the group of veterans that starts the video sessions right away with a group that waits before starting the video sessions.
详细描述
The study will be achieved by conducting a two-arm, single-blind, pilot randomized controlled trial at two VA medical centers. Eighty participants at each site will be randomized in a 1:1 ratio to either the MiND-MCI group or waitlist control group. Participants will be Veterans ages 60 and older with a diagnosis of MCI, at least one cardiovascular risk factor, self-reported cognitive complaint, and self-reported difficulty adjusting to MCI diagnosis or symptoms. MiND-MCI will be delivered in nine weekly 60-minute sessions via telehealth in groups of 5 to 7 Veterans. Feasibility and acceptability process data will be tracked throughout the study. Acceptability measures pertaining to participants' perceptions of MiND-MCI will be collected at post-treatment using quantitative and qualitative assessment methods. Outcome measures collected at baseline, post-treatment, and 12-week follow-up will assess global QoL, MCI-related QoL, MCI-related self-efficacy, depression, anxiety, loneliness, coping, and cognitive functioning.
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
Assessor and fidelity monitor will be blinded to treatment group.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 60 or older
- •diagnosis of MCI, diagnosed at least a month or longer prior to screening
- •diagnosis of at least one cardiovascular risk factor (i.e., hypertension, diabetes mellitus II, hyperlipidemia/hypercholesterolemia, or obesity)
- •self-reported cognitive complaint (i.e., "Do you have problems with your memory or thinking abilities?")
- •self-reported difficulty adjusting to declines in cognitive functioning (i.e., "Have these problems with memory or thinking impacted you, your life, or others in your life?")
- •English speaking, and (h) ability to provide written informed consent
排除标准
- •diagnosis of dementia or a neurodegenerative disorder
- •diagnosis of serious mental illness likely to impact cognition (i.e., schizophrenia or bipolar I disorder)
- •acutely suicidal or homicidal
- •actively psychotic
- •active substance use disorder
- •limited life expectancy due to a terminal medical condition
- •receiving ongoing chemotherapy or radiation treatment at time of screening
- •residing in an assisted living or residential care facility
- •currently participating in another psychotherapy, health promotion intervention, or cognitive training program, and
- •any significant changes to psychotropic medications or medications for memory and cognition in the past month. Participants prescribed psychotropic medications and medications for memory and cognition will be asked to stay on their current dosages for the duration of the study.
结局指标
主要结局
Feasibility of a group video-telehealth intervention for veterans with MCI
时间窗: At Week 0 (randomization)
percentage of screened, eligible subjects that enroll in intervention
Acceptability of a group video-telehealth intervention for veterans with MCI
时间窗: At Week 10 (one week after completion of the 9 video-telehealth sessions)
percentage of subjects that attend 70% or more of scheduled sessions
次要结局
- Change in the Quality of Life in Alzheimers Disease (QOL-AD, range of 13-52) scale in Veterans with Mild Cognitive Impairment following participation in a 9-week video-telehealth intervention.(baseline to 12 week post-treatment follow-up visit)
研究者
Lori Davis, MD
Associate Chief of Staff, Research Service, Tuscaloosa Veterans Affairs Medical Center
Tuscaloosa Research & Education Advancement Corporation