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临床试验/NCT05102565
NCT05102565已完成不适用

A Dyadic Telehealth Program to Support Alzheimer's Disease Patients and Their Caregivers During COVID-19

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Pittsburgh Sleep Quality Index score

研究概览

简要总结

This study aims to refine and evaluate feasibility of a telehealth intervention for persons with Alzheimer's disease and their caregivers. The intervention will use evidence-based techniques for decreasing symptoms of depression, anxiety, and poor sleep, that are commonly reported among this vulnerable group during the COVID-19 pandemic. Improved symptoms among this group may improve their other health outcomes and quality of life and furthermore the quality of care that caregivers provide for persons with Alzheimer's disease during this challenging time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Inclusion criteria for patients
  • Have a diagnosis of AD (probable or possible), other related dementia, or mild cognitive impairment as documented in electronic medical record
  • Community-dwelling
  • Aged > 50 years
  • Have no previously diagnosed sleep disorders (e.g., sleep apnea, restless legs syndrome)
  • Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
  • Have an eligible caregiver
  • Inclusion criteria for caregivers
  • Aged >18 years
  • Live with the eligible patient
  • Have regularly assisted the care recipient with >1 of 7 basic activities of daily living (ADLs; i.e., eating, dressing/undressing, grooming, walking across a room, getting in and out of bed, bathing, toileting) or >1 of 7 Instrumental ADL (IADLs; i.e., using the telephone, getting to places beyond walking distance, shopping, preparing meals, doing housework, taking medicine, handling money) for the past 6 months
  • Have no history of cognitive impairment
  • Can communicate in English.

排除标准

  • Professional caregivers will be excluded. Patients will be excluded if they are bedbound. If the eligibility criteria for either a patient or a caregiver are not met, their dyads will be excluded for this study

结局指标

主要结局

Pittsburgh Sleep Quality Index score

时间窗: immediately after the last session of the intervention

Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.

Sleep efficiency-Actigraphy

时间窗: immediately after the last session of the intervention

Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality

次要结局

  • Total scores on the Patient Health Questionnaire-9(immediately after the last session of the intervention)
  • Total scores on the Rating Anxiety in Dementia(immediately after the last session of the intervention)
  • Total scores on the Generalized Anxiety Disorder-7(immediately after the last session of the intervention)
  • Total scores on the Cornell Scale for Depression in Dementia(immediately after the last session of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeonsu Song, PhD, RN, FNP

Assistant Professor

University of California, Los Angeles

研究点 (2)

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