Using Mobile Technology to Reduce Stress in Caregivers of Persons With Dementia. A Scalable Solution to a Growing Problem.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
The investigators aim to conduct a feasibility, proof of concept randomized controlled trial (RCT) of a smartphone app intervention (Healthy Minds Program; HMP) versus Wellness app (WA) among heterogeneous stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The investigators will test its feasibility (primary outcomes) and its preliminary effect in improvement in caregiver stress, emotional distress (depression and anxiety), and mindfulness. Participants will be randomized to one of the two conditions described above
详细描述
Using the NIA 2 year R21 grant mechanisms, we will examine the feasibility (markers of acceptability and demand), and proof of concept of Healthy Minds Program (HMP) versus Wellness App (WA) in decreasing stress and emotional distress in heterogeneous, geographically diverse, stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). Participants in each arm will be asked to practice for 10 min/day.
To achieve our aims, we will conduct a single blind, pilot, feasibility, proof of concept randomized controlled trial (RCT) of HMP (12 weeks, > 10 minutes daily) versus WA; 12 weeks, >10 minutes daily). Assessments will be conducted at baseline, post program (12 weeks later) and at 20 weeks follow-up (~2 months after post-test). Caregivers will also complete weekly assessments.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •English fluency and literacy
- •Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
- •Perceived Stress Scale (4 items) version >= 6
- •Willing to be randomized
- •Care recipient must score >1 on the functional assessment scale (FAST)
排除标准
- •Any planned change in psychotropic pharmacologic treatment for the duration of the study
- •Use of any consumer-based mindfulness meditation app for more than 60 min/month in the past 6 months.
- •Current participation in a meditation program (e.g., mindfulness-based stress reduction, mindfulness-base cognitive therapy, etc.)
- •Major illness known to worsen dramatically or require surgery in the next 20 weeks (study duration)
- •Active treatment for cancer (chemotherapy, radiation)
- •Imminent placement of care recipient in a nursing home or with another caregiver (within 4 months).
- •Involvement in another clinical trial for caregivers.
- •For participants age 65 and older: four or more errors on the Short Portable Mental Status questionnaire (SPMSQ)
结局指标
主要结局
Feasibility of Recruitment
时间窗: 0 weeks
We will assess number of dementia caregivers enrolled from the number of caregivers that were eligible. Our primary aim focuses on feasibility of recruitment during the trial.
Perceptions of daily meditations/podcast
时间窗: 12 weeks
We will assess caregivers' perception of their app's prescription by asking, "Do you think that the amount of daily prescribed app content was: too little, just enough, or too much?"
Perceptions of emails and text reminders
时间窗: 12 weeks
We will assess caregivers' perception of emails and text message reminders by asking, "Do you think that the amount of emails/texts you received was: too little, just enough, too much?"
Feasibility of weekly Research Electronic Data Capture (RedCAP) measures
时间窗: 12 weeks
We will assess the feasibility of the weekly REDCap measures sent to patients by review of responses to ensure that \>=70% caregivers will answer \>=75%.
Client Satisfaction Questionnaire (CSQ-3)
时间窗: 12 weeks
This will be used to assess caregivers' satisfaction with the intervention. Scores range from 3 to 12, with higher values indicating higher satisfaction.
Adherence to one of the two apps
时间窗: 12 weeks
We will assess data from the Healthy Minds Program app and the Podcast app to measure adherence to the intervention and the control conditions. Our benchmark will be that \>=70% of caregivers will complete \>=75% of weekly prescribed minutes (\>=10 minutes/day).
Credibility and Expectancy Questionnaire (CEQ)
时间窗: 0 weeks
We will use the Credibility and Expectancy Questionnaire (CEQ) to assesses caregivers perceptions that the treatment will work after learning about the study. Scores range from 3-27; higher ratings indicate more belief that the program is logical and will help with the intended outcome.
Perceptions of the overall study
时间窗: 12 weeks
We will assess caregivers' perceptions of the study by asking, "Do you have any feedback about your experience in this program (content of the program, content of the text message reminders, etc.) that you would like to share?"
Perceptions of prompts/contacts in low adherence situations
时间窗: 12 weeks
We will assess caregivers' perception of the amount of prompts and contact in situations where they were not adhering to their practice by asking "Do you think that the amount of prompts you received when you struggled with your practice was: too little, just enough, too much?"
Feasibility of quantitative measures
时间窗: 20 weeks
We will assess the feasibility of the quantitative measures sent to caregivers with the benchmark of no questionnaires missing fully in \>=25% caregivers.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(0 weeks, 12 weeks, 20 weeks)
- Applied Mindfulness Process Scale (AMPS)(0 weeks, 12 weeks, 20 weeks)
- Stress Thermometer(0-12 weeks, 20 weeks)
- Mindfulness Thermometer(0-12 weeks, 20 weeks)
- Emotional Distress Thermometer(0-12 weeks, 20 weeks)
- Modified Patient Global Impression of Change (MPGI)(12 weeks)
- Perceived Stress Scale 10 items (PSS-10)(0 weeks, 12 weeks, 20 weeks)
- Healthy Minds Index(0 weeks, 12 weeks, 20 weeks)
- Caregiver Reaction Scale(0 weeks, 12 weeks, 20 weeks)
- Hospital Anxiety and Depression Scale (HADS)(0 weeks, 12 weeks, 20 weeks)
- Modified Patient Global Impression of Change (MPGI)(12 weeks)
- Applied Mindfulness Process Scale (AMPS)(0 weeks, 12 weeks, 20 weeks)
- Stress Thermometer(0-12 weeks, 20 weeks)
- Mindfulness Thermometer(0-12 weeks, 20 weeks)
- Emotional Distress Thermometer(0-12 weeks, 20 weeks)
- Perceived Stress Scale 10 items (PSS-10)(0 weeks, 12 weeks, 20 weeks)
- Healthy Minds Index(0 weeks, 12 weeks, 20 weeks)
- Caregiver Reaction Scale(0 weeks, 12 weeks, 20 weeks)
研究者
Ana-Maria Vranceanu, PhD
Associate Professor/Director
Massachusetts General Hospital