My Healthy Brain: A Group-Based Lifestyle Intervention to Modify Early Risk of Dementia in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Credibility and Expectancy Questionnaire
研究概览
简要总结
The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.
详细描述
The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot randomized control trial (RCT) comparing two virtual lifestyle programs, My Healthy Brain 1 and My Healthy Brain 2. Eligible older adults include: age ≥ 60, self-reported worry about changes in memory or thinking, and risk factors for dementia (determined by the Cardiovascular Risk Factors, Aging, and Incidence of Dementia score ≥ 6). Participants will be randomized to one of two groups (My Healthy Brain 1 or My Healthy Brain 2) and will complete 8 weekly 90-minute sessions via Zoom delivered by a clinical psychologist. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs. The investigators will also explore improvements in cognition, lifestyle behaviors (physical activity, sleep, nutrition, alcohol and tobacco use, social functioning), depression, anxiety, and mindfulness assessed at baseline, post-intervention, and 6 month follow-up. All participants will wear a watch to monitor changes in lifestyle during the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 or older
- •Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6
- •Telephone Interview for Cognitive Status-41 ≥ 31
- •Functional Assessment Questionnaire < 9
- •English fluency/literacy
- •Ability and willingness to participate via live video
- •No self-reported safety issues with initiating lifestyle changes during the study
排除标准
- •Mild cognitive impairment, dementia, or neurodegenerative disease
- •Psychotropic medications (e.g., antidepressant) change in the last 3 months
- •Psychosis, uncontrolled bipolar disorder or substance dependence; schizophrenia or schizoaffective disorder
- •Current self-report of suicidal ideation
- •Serious medical illness expected to worsen in 6 months (e.g., cancer)
- •Use of digital monitoring device (e.g., Fitbit) in the last 3 moths AND unwillingness to stop using personal digital monitoring device for duration of program
- •Mindfulness or mind-body practice (> 45 min/wk) focused on lifestyle, cognitive-behavioral therapy in < 3 months, or participation in a lifestyle prevention program (ex: diabetes prevention) in < 3 months
- •Average daily step count > 5,000 steps
- •More than 30 minutes of exercise daily
结局指标
主要结局
Credibility and Expectancy Questionnaire
时间窗: 0 Weeks
Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy.
Client Satisfaction Questionnaire
时间窗: 8 Weeks
Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.
Rates of Recruitment and Enrollment
时间窗: 0 Weeks
We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to participate divided by the total number contacted (≥70% good, ≥ 80% excellent).
Rates of Missing Outcomes Data
时间窗: 8 Weeks
We will assess the feasibility of data collection by calculating the proportion of secondary outcomes (cognition and lifestyle) with no missing data divided by the total number collected (≥70% good, ≥ 80% excellent).
Rates of Valid Activity Watch Data (10 or more hours of wear time)
时间窗: 8 Weeks
We will assess the feasibility of collecting valid activity watch data by calculating the proportion of participants who wore the watch at least 5 out of 7 days per week for at least 10 or more hours per day, divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).
Rates of Ecological Momentary Assessment (EMA) Data
时间窗: 8 Weeks
We will assess the feasibility of collecting ecological momentary assessment (EMA) of daily mindfulness practice by calculating the proportion of participants who complete at least 5 out of 7 daily surveys per week (≥ 70% good, ≥ 80% excellent).
Rates of Treatment Completion
时间窗: 8 Weeks
We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).
Rates of Therapist Fidelity to Intervention Procedures
时间窗: 8 Weeks
We will assess the fidelity of therapists to the intervention procedures by calculating the proportion of sessions with completed audio recordings, progress notes, and checklist with 100% of content delivered divided by the total number of sessions (≥ 75% good, 100% excellent).
Rates of Staff Fidelity to Study Procedures
时间窗: 8 Weeks
We will assess the fidelity of staff to the study procedures by counting the frequency of protocol deviations (\<5 deviations good, 0 deviations excellent).
Modified Patient Global Impression of Change at 8 weeks
时间窗: 8 Weeks
The proportion of participants who report perceived improvements in cognitive function, lifestyle, and emotional well-being outcomes (1=Very Much Worse, 7=Very Much Improved).
Rate of Adverse Events
时间窗: 8 Weeks
We will assess the safety of the study by founding the number and severity of adverse events (mild in ≤ 10% of participants = good, none = excellent).
次要结局
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(0 Weeks, 8 Weeks, 6 Months)
- Cognitive Function Instrument(0 Weeks, 8 Weeks, 6 Months)
- Change in Step Count(0 Weeks, 8 Weeks, 6 Months)
- PROMIS Physical Function(0 Weeks, 8 Weeks, 6 Months)
- Change in Total Sleep Time(0 Weeks, 8 Weeks, 6 Months)
- Pittsburgh Sleep Quality Index(0 Weeks, 8 Weeks, 6 Months)
- Mediterranean Eating Pattern for Americans Screener(0 Weeks, 8 Weeks, 6 Months)
- PROMIS Alcohol Use(0 Weeks, 8 Weeks, 6 Months)
- CDC Other Tobacco Product Use Questions(0 Weeks, 8 Weeks, 6 Months)
- PROMIS Satisfaction with Social Roles and Activities(0 Weeks, 8 Weeks, 6 Months)
研究者
Ryan A., Mace, PHD
Staff Psychologist
Massachusetts General Hospital