Self-Care for Dementia Caregivers Using the myRhythmWatch
概览
- 阶段
- 不适用
- 干预措施
- Behavioral Self-Monitoring + Motivational Interviewing
- 疾病 / 适应症
- Aging
- 发起方
- University of Pittsburgh
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pre/Post Change in Depressive Symptoms
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The Self-care for Dementia Caregivers Study is a behavioral health intervention that uses digital monitoring tools and motivational health coaching to help caregivers of persons with dementia engage in a regular routine of sleep and activity. Participants wear an apple watch for the objective collection of sleep-wake rhythms. They receive personalized feedback on their sleep-wake rhythms via a new app. Health coaches call participants weekly, for up to 6 weeks to help participants meet their health/sleep goals and promote self-knowledge of regular routines. Participants will help the study team improve the design elements and content of the mobile app. The goal of this intervention is to reduce depressive and insomnia symptoms.
详细描述
Caregivers of family members with Alzheimer's Disease (AD) and AD-related dementias (ADRD) experience high rates of psychological stress, physical impairments, and often, disruptions in normal daily activities. Caregivers must be alert both at night and during the day, and often on an inconsistent schedule. As a result, caregivers are less likely to sleep, exercise, and be socially active on a regular schedule. Disruptions of these biological and behavioral time cues, or "zeitgebers", in turn decrease the stability of the body's biological clock, placing caregivers at high risk for adverse health outcomes related to an out-of-sync biological clock (e.g. diabetes, cardiovascular disease, and depression, among others). Caregivers of individuals with ADRD experience worse health outcomes compared with other types of caregivers, likely due to more heavily or frequently disrupted schedules. For this research study, up to 25 individuals aged 50 and older who are providing care for a family member with mild-to-moderate dementia will be included. Data from 5 participants will be used for the development of an intervention manual (NIH Stage Model IA). A small pilot study will be conducted (NIH Stage Model IB) in which 20 participants will use a new mobile app - my rhythm watch - for up to 6 weeks. Objective actigraphic measures of the 24-hour pattern of sleep and daytime activity - known as the circadian rest-activity rhythm (RAR) - will be measured continuously via the apple watch to evaluate circadian rhythms as a potential intervention target/mechanism of action. The investigators will measure the regularity, timing, and amplitude of behavioral patterns over a 24-hour period. Participants will be assessed at baseline, post-intervention, and 3-months post-intervention. Initially our plan was to focus an intervention on promoting self-care and reducing caregiving burden. However, in designing the trial, we switched the focus to the circadian-informed, behavioral activation-based approach that aimed to improve sleep and mood in caregivers. Therefore, the two main outcomes of interest were measures of depression symptom severity and insomnia symptom severity. The study as described in the original registration (April 2022) never proceeded. The registration has been revised to reflect the study as modified after securing a technology partner (per funding requirements) and prior to study initiation
研究者
Sarah T. Stahl, PhD
Associate Professor of Psychiatry and Clinical and Assistant Professor of Translational Science
University of Pittsburgh
入排标准
入选标准
- •for ADRD patients include:
- •being ≥60 years
- •having been diagnosed with Alzheimer's disease, vascular dementia, mixed Alzheimer's/vascular dementia, or frontotemporal dementia
- •living with their caregiver
- •being willing to wear the watch and participate in assessments and calls
- •Inclusion criteria for ADRD caregivers include:
- •being a primary caregiver for an ADRD patient
- •being ≥50 years
- •experiencing stress/strain related to caregiving
- •the person being cared for has problems with sleep or keeping a consistent routine
排除标准
- •for ADRD patients include:
- •being less than 60 years
- •not having a diagnosis of ADRD
- •not living with their caregiver
- •not being willing to wear the watch and participate in assessments and calls
- •Exclusion criteria for ADRD caregivers include:
- •being less than 50 years
- •not experiencing stress/strain related to caregiving
- •the person being cared for does not have problems with sleep or keeping a consistent routine
- •scoring \<5 on the PHQ-9
研究组 & 干预措施
Caregiver Intervention
Behavioral self-monitoring of sleep and activity up to 6 weeks, using the myRhythmWatch app, and motivational health coaching.
干预措施: Behavioral Self-Monitoring + Motivational Interviewing
结局指标
主要结局
Pre/Post Change in Depressive Symptoms
时间窗: Up to 6 weeks
The 9-item Patient Health Questionnaire (PHQ-9) scale is a self-reported questionnaire to be completed by the participant that assesses severity of depression. The PHQ-9 will be administered throughout the study to assess changes in depressive symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 27, indicating more severe impacts to patient health.
Pre/Post Change in Insomnia Symptoms
时间窗: Up to 6 weeks
The 7-item Insomnia Severity Index (ISI) is a self-reported questionnaire to be completed by the participant that assesses severity of insomnia. The ISI will be administered throughout the study to assess changes in insomnia symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 28, indicating more severe impacts to patient health.