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临床试验/NCT04517877
NCT04517877已完成2 期

Caring Light Project for Caregivers of Individuals With Alzheimer's Disease

Photozig, Inc.2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
164
试验地点
2
主要终点
Perceived Stress Scale

研究概览

简要总结

Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related dementia to cope with the difficulties related to caregiving, reduce stress, and improve quality of life.

详细描述

The goals of this study are to evaluate materials related to dementia caregiving and how to cope with difficult situations faced by caregivers. Based on this research, the investigators are developing the new Caring Light mobile app with a self-paced program to enhance the quality of life, a curriculum that incorporates relaxation techniques, and coping skills training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Care for an individual with Alzheimer's Disease or other dementia.
  • Own a smartphone or tablet and have Internet access.
  • Minimum age of 18 years old.
  • Spend at least 8 hours/week caring for a person with dementia.

排除标准

  • Severe psychological or physical illness.
  • Inability to read and follow English instructions.
  • High level of depressive symptoms.
  • Unwillingness to participate in all aspects of the study.

结局指标

主要结局

Perceived Stress Scale

时间窗: 3 months

The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.

Revised Memory and Behavior Problems Checklist

时间窗: 3 months

This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.

Center for Epidemiological Studies Depression Scale

时间窗: 3 months

The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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