The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic Mild Cognitive Impairment and Alzheimer's Disease (MOMENT) Study: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months
研究概览
简要总结
The purpose of this research study is to learn whether it is possible and useful for caregivers to report behavioral or psychological symptoms of people with mild memory problems or Alzheimer's disease through a smartphone mobile application. The investigators believe that monitoring these symptoms and having a tool, like a mobile application, can provide quicker accessibility to the patient's clinical care team, which could improve care for patients and caregivers.
These types of symptoms found in patients with mild memory problems or Alzheimer's disease are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of these brain illnesses. Examples of psychological and behavioral symptoms are depression, anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can lead to greater use of healthcare services.
详细描述
As a part of this research study the patient and caregiver will undergo randomization, "like flipping a coin", to assign the patient and caregiver to one of two research study groups. The patient and the partnered caregiver will join the same group. The group will either receive: 1) three in-person assessments on symptoms and behaviors that the patient may experience and a mobile application that will send surveys to the caregiver in order to rate the presence, severity and stress caused by these symptoms and behaviors; or 2) three in-person assessments on symptoms and behaviors that the patient may experience and no mobile application. The outcomes of these surveys and assessments will then be shared with the patient's clinical team.
If the caregiver is assigned to the group that receives the mobile application they will receive the surveys either weekly or monthly. After each month of completing the surveys, the frequency will change. Depending on feedback from the first 10 participants, the investigators may modify the survey rate to happen more than weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator will be masked to arm allocation of participants. The outcomes assessor at time of 3 month and 6 month (final) assessment will also be masked to the allocation of participants.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient:
- •Has Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (aMCI), is a Healthy Aging Brain Center, Eskenazi Health patient
- •Community dwelling
- •Has a legally authorized representative when they lack capacity to consent
- •The caregiver:
- •18 or older
- •No visual impairment
- •Community dwelling
- •Reports seeing patient most days of the week
排除标准
- •The patient:
- •History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)
- •Participating in another study
- •The potential participant with a diagnosis of either aMCI or AD communicates observable dissent.
- •The caregiver:
- •History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)
- •Participating in another study
结局指标
主要结局
Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months
时间窗: Calculated at 6 months
Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint
时间窗: Measured at 3 months
The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.
时间窗: Measured at 6 months
The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months
时间窗: Calculated at 3 months
Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months
时间窗: Calculated at 3 months
Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application.
Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months
时间窗: Calculated at 6 months
Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application.
次要结局
- Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.(Calculated at 3 months)
- Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.(Calculated at 6 months)
- Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.(Calculated at 3 months)
- Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.(Calculated at 6 months)
研究者
Chris Callahan, MD
Professor of Medicine
Indiana University