跳至主要内容
临床试验/NCT04077450
NCT04077450撤回不适用

Effectiveness of Heart-focused Breathing on Reducing Burden in Alzheimer's Caregivers: An Online Randomized Pilot Study

Arizona State University2 个研究点 分布在 1 个国家开始时间: 2019年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Caregiver Burden

研究概览

简要总结

This research study will explore the effects of an online heart-focused breathing intervention on 20 informal caregivers of patients with Alzheimer's Disease (AD) over a period of two weeks.

详细描述

Informal caregivers are often live-in, unpaid spouses, relatives, partners, or friends that help with a loved one's activities of daily living. As a result of caring for a person with Alzheimer's Disease (AD), many informal caregivers experience caregiver burden. The demanding physical, emotional, and financial responsibilities to care for an AD patient can be detrimental to the caregiver's health.

A group of 20 men and women who consider themselves the primary caregiver of a person with AD will be recruited and enrolled into the study. Participants will be randomized into one of two study arms, (a) the modified-waitlist control arm or (b) the intervention arm. The study will explore the effects of an online heart-focused breathing intervention on heart rate variability (measured by the Welltory app on their smart device), perceived burden, stress, and quality of life in the intervention arm over a two-week period.

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)

盲法说明

Only participants will be blinded as to which study arm he or she was assigned.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • 18 years of age or older
  • Live-in and unpaid informal caregiver to a loved one with Alzheimer's Disease
  • Provides care or supervision for at least 4 hours per day for more than 6 months
  • Experiencing stress

排除标准

  • Caregivers who report a low risk assessment score and/or report a medically diagnosed arrhythmia or have a pacemaker will be excluded

结局指标

主要结局

Caregiver Burden

时间窗: 2 weeks

Caregiver Burden will be measured by the Zarit Burden Interview short version (12 items, 5-point Likert scale; 0= never, 4= nearly always). Score range= 0 to 48. A score of 17 or higher indicates a high level of burden.

次要结局

  • Life Quality(2 weeks)
  • Perceived Stress(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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