Compensation Training and Lifestyle Modifications to Promote Healthy Aging in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention (Brain Boosters 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Digit Span
研究概览
简要总结
The purpose of this research is to determine if training in memory support aids and healthy lifestyle activities (physical exercise, mentally stimulating activities and stress management) can have a positive effect on memory, thinking, and activities that people do every day. Participation in this study will involve being placed into one of two groups: a Self-Guided Intervention Group or a Structured Intervention Group. Both groups will be asked to attend group sessions in which they will be provided education on memory support strategies and lifestyle changes. The Structured Intervention Group will also be provided with an iPad and a digital application (called EMMA) to track their activity. Study participation involves a 6-month intervention and completing outcome measures at 4 different time points for up to a year.
详细描述
Participants in this research will be asked to participate in group sessions about memory support strategies and healthy behaviors. They may also choose to have a partner participate in this study with them, but it is not required.
There will be weekly sessions for 10 weeks, followed by sessions 1 to 2 times per month for the next 4 months.
Participants will be asked to complete healthy lifestyle activities on their own. Before the intervention starts and at three time points after the intervention, we will collect cognitive assessments and questionnaires to measure the possible impact of the treatment. The post-intervention assessments will take place right after completion of the intervention, and then 6 and 12 months later.
Before the start of the study, participants will be required to get permission from their primary care provider to ensure that it is safe for them to complete physical aerobic exercise.
The Self-Guided and Structured Intervention Groups will be required to participate in the following study activities:
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 (Outcomes Assessor)
盲法说明
The outcomes examiner will be blinded to participants' study arm assignment.
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The target population is cognitively normal older adults with Subjective Cognitive Concerns (SCC). SCC will be operationalized as
- •a positive complaint in response to the question: 'Have you experienced a decline in your memory or other aspect of thinking in the last 1-3 years that seems worse than others of your age'
- •normal cognition on the modified Telephone Interview of Cognitive Status (mTICS)
- •independent function in daily life.
- •Age 65 or older
- •English speaking
- •Lower level of engagement in healthy lifestyle behaviors and compensation use at study baseline (i.e., broadly defined as not a regular exerciser)
- •Approval from primary care (due to physical exercise component of the intervention)
- •Open to utilizing digital tools such as a digital calendar in daily life
排除标准
- •Known diagnosis of dementia or cognitive impairment;
- •Other known neurological condition with potential to affect cognition (e.g., Parkinson's disease)
- •Reported history of severe psychiatric disorder (e.g., self-reported history of bipolar disorder or schizophrenia or other psychotic disorder)
- •Inability to complete the study protocols due to severe vision or hearing difficulties.
- •Has previously participated in a previous version of Brain Boosters, or another study utilizing the Digital Memory Notebook (DMN) application or EMMA.
研究组 & 干预措施
Self-Guided Group
Subjects in this group will be provided education on memory support strategies and healthy lifestyles. Participants will decide how they want to implement this information into their daily lives. The study will also provide information on various commercially available digital and other tools that might help participants implement healthy changes their lives. One in every three participants will be enrolled in this group (selected randomly).
干预措施: Self-Guided (Behavioral)
Structured Group
Subjects in this group will will be provided with specific recommended behavior targets (e.g., like how much exercise you should engage in each week). Participants will also receive an iPad to use throughout the study and follow up period with the digital application installed. Subjects will be asked to use the digital application to record their activity and to receive reminders to complete this information. Two in every three participants will receive the iPad and digital application. Participants in this group will receive training on how to use the digital application. The researchers can install the digital application on the subjects' personal iPad or smartphone if they prefer.
干预措施: Structured Group (Behavioral)
结局指标
主要结局
Digit Span
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of attention and working memory by recalling short lists of numbers immediately in either forward or backwards order.
Everyday Function
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
Evaluates participants everyday cognition through a variety of self-report questions about their daily functioning.
Verbal Fluency
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of executive functioning by having participants list as many words they can that start with a specific letter.
Free and Cued Selective Reminding Test (FCRT)
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of immediate and delayed memory by using cues or free recall
Digit Symbol
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of executive functioning by having participants match symbols and letters.
Logical Memory
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of narrative episodic memory.
Trail Making
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of executive functioning by assessing following order but switching between letters and numbers.
Royal Prince Alfred Prospective Memory Test
时间窗: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of prospective memory by asking participants to remind the examiner of a task at different intervals throughout the session.
次要结局
- Satisfaction with Life(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Coping Self efficacy (CSES)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Purpose in Life(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Brief Resiliency Scale (BRS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Cooperative Study Activities of Daily Living (ADL) Prevention Instrument (ADCS-ADL-PI)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Short Physical Performance Battery(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Mindfulness Inventory(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Perceived Stress Scale (PSS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Everyday Compensation (EComp)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- The Gratitude Questionnaire - Six Item Form(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Patient Reported Outcomes Measurement Information System (PROMIS) General Health and Quality of Life Measure(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Positive Affect and Negative Affect Scale (PANAS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Community Healthy Activities Model Program for Seniors (CHAMPS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)