NCT05383027Unknown不适用
Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study(CARES)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Brief Resilience Scale
研究概览
简要总结
In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •18 years and above
- •primary, unpaid family caregiver for ADRD patient for 6 months or more
- •owns and operates a smartphone with a data plan
- •greater than of equal to 4 on caregiver burden scale
排除标准
- •regular mind-body practice
- •under 18 years old
- •pacemaker
- •conditions or medications that interfere with heart rate variability
结局指标
主要结局
Brief Resilience Scale
时间窗: 13 weeks
Measures participant resillience
Perceived Stress Scale-10
时间窗: 13 weeks
Measure of stress
Zarit Burden Interview
时间窗: 13 weeks
Measures participant burden
次要结局
未报告次要终点
研究者
研究点 (2)
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