Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 272
- 试验地点
- 6
- 主要终点
- Improvement in patient quality of life
研究概览
简要总结
This study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g. quality of life, cognition, function, mood) matter most to people at risk for dementia and their care partners. The results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. Greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. This, in turn, can lessen the need for medication, health care, and long term care utilization.
详细描述
Traditional randomized controlled trials (RCTs) can be thought of as 'additive' trials where randomization leads to the addition of treatments beyond placebo. Participants are confronted with the probability of receiving placebo (no treatment). This leads many potential participants to not consent or to withdraw if they believe they are receiving no treatment. In contrast, the proposed trial will be 'subtractive'. This innovative approach to randomization will involve suppression of just 1 of the 5 treatment components. Thus, all participants will receive at least 80% of the menu of interventions offered in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A candidate for the HABIT program with a diagnosis of amnestic MCI (confirmed at eligibility visit by a Clinical Dementia Rating (CDR) scale of 0.5).
- •A cognitively normal care partner who has at least twice-weekly contact with the participant.
- •Either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months.
- •Fluent in English. (Expanding the program to communities of Spanish- speakers will be a high priority in subsequent dissemination work).
排除标准
- •Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
- •Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.
研究组 & 干预措施
No Cognitive Rehabilitation
Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
干预措施: Computer Brain Fitness Training (Behavioral)
No Cognitive Rehabilitation
Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
干预措施: Support Group (patient and partner) (Behavioral)
No Cognitive Rehabilitation
Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
干预措施: Wellness Education (Behavioral)
No Cognitive Rehabilitation
Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.
干预措施: Physical Exercise (Behavioral)
No Physical Exercise
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
干预措施: Support Group (patient and partner) (Behavioral)
No Computer Brain Fitness Training
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise
干预措施: Cognitive Rehabilitation (Behavioral)
No Computer Brain Fitness Training
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise
干预措施: Support Group (patient and partner) (Behavioral)
No Computer Brain Fitness Training
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise
干预措施: Wellness Education (Behavioral)
No Computer Brain Fitness Training
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise
干预措施: Physical Exercise (Behavioral)
No Support Group
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise
干预措施: Cognitive Rehabilitation (Behavioral)
No Support Group
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise
干预措施: Computer Brain Fitness Training (Behavioral)
No Support Group
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise
干预措施: Wellness Education (Behavioral)
No Support Group
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise
干预措施: Physical Exercise (Behavioral)
No Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise
干预措施: Cognitive Rehabilitation (Behavioral)
No Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise
干预措施: Computer Brain Fitness Training (Behavioral)
No Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise
干预措施: Support Group (patient and partner) (Behavioral)
No Wellness Education
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise
干预措施: Physical Exercise (Behavioral)
No Physical Exercise
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
干预措施: Cognitive Rehabilitation (Behavioral)
No Physical Exercise
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
干预措施: Computer Brain Fitness Training (Behavioral)
No Physical Exercise
Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education
干预措施: Wellness Education (Behavioral)
结局指标
主要结局
Improvement in patient quality of life
时间窗: baseline to 18 months
quality of life measured by the QOL-AD scale
次要结局
- improvement in caregiver mood and sense of burden(baseline to 18 months)
- improvement in patient memory based everyday functioning(baseline to 18 months)