跳至主要内容
临床试验/NCT05562583
NCT05562583已完成不适用

SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support

BrightOutcome2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
BrightOutcome
入组人数
15
试验地点
2
主要终点
Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant

研究概览

简要总结

The goal of the proposed study, is to adapt a positive emotion intervention for Alzheimer's Disease (AD) caregivers into a self-guided online format that incorporates social connection components and adaptive system feedback mechanisms to promote intervention adherence. Previous tests of the facilitated version of the program, called SAGE-LEAF (Social Augmentation to self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), have shown efficacy for improving well-being in dementia caregivers. If effective, the SAGE-LEAF program can be disseminated to Alzheimer's caregivers nationwide through AD treatment and research centers.

详细描述

The prevalence of Alzheimer's Disease (AD) and other dementias is steadily climbing and predicted to affect as many as 16 million Americans by 2050. In 2016, 59% of dementia caregivers reported experiencing high levels of emotional and physical stress, and the risk that the chronic stress of dementia caregiving places on caregivers for developing a range of physical and mental health issues is extensively documented. Caregiving-related stress contributes to social isolation, loneliness, and physical illness and increases the risk of caregiver death. Interventions for dementia caregivers have primarily focused on reducing negative emotions and burden. However, over the past few decades, it has become clear that positive emotions are uniquely related to better psychological and physical well-being, independent of the effects of negative emotion suggesting that an intervention that specifically targets positive emotion holds promise for improving caregiver well-being and, ultimately, quality of care for the individual living with AD. The investigators' recent randomized trial of the positive emotion skills intervention, delivered by trained facilitators via the web in N = 170 family caregivers of people with dementia resulted in significant improvements in caregiver psychological well being. However, facilitator-delivered interventions are costly and difficult to implement with fidelity on a large scale. Furthermore, a major challenge to advancing behavioral interventions delivered by trained facilitators is assuring fidelity. The investigators have developed a self-guided online version of the intervention that has shown feasibility and acceptability in several samples, but this version does not capture the critical social connection aspects of the facilitator-delivered intervention. The investigators propose to take the next step toward closing the science-to-practice gap for the positive emotion regulation intervention by tailoring the self-guided online version specifically for dementia caregivers that incorporates the social connection components to combat the loneliness and isolation experienced by many Alzheimer's caregivers. The intervention, called SAGE-LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), leverages the lessons learned from the original LEAF project and adapts its positive emotion intervention to AD caregivers in a self-guided format while incorporating social connection components and adaptive system feedback mechanisms to promote intervention adherence.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 18 and over who identify as the primary caregiver of a family member with Alzheimer's Disease
  • Co-reside with the family caregiver
  • Speak and read English
  • Have internet access and a reliable email address

排除标准

  • 未提供

结局指标

主要结局

Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant

时间窗: Post-study (week 6)

This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.

Willingness to Recommend SAGE-LEAF to Other AD Caregivers

时间窗: Post-study (week 6)

This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.

System Usability Scale

时间窗: Post-study (week 6)

This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.

次要结局

  • Oberst Caregiving Burden Scale - Time(Pre-study and post-study (week 6))
  • Zarit Burden Interview(Pre-study and post-study (week 6))
  • Caregiving Mastery Subscale of the Caregiving Appraisal Measure(Pre-study and post-study (week 6))
  • Role Captivity Sub-scale of Caregiver Reaction Assessment(Pre-study and post-study (week 6))
  • Oberst Caregiving Burden Scale - Difficulty(Pre-study and post-study (week 6))
  • Positive Aspects of Caregiving Scale(Pre-study and post-study (week 6))
  • Overload Sub-scale of Caregiver Reaction Assessment(Pre-study and post-study (week 6))
  • Cohen's Perceived Stress Scale(Pre-study and post-study (week 6))
  • Patient-Reported Outcomes Measurement Information System - Depression(Pre-study and post-study (week 6))
  • Patient-Reported Outcomes Measurement Information System - Anxiety(Pre-study and post-study (week 6))
  • Patient-Reported Outcomes Measurement Information System - Meaning and Purpose(Pre-study and post-study (week 6))
  • Patient-Reported Outcomes Measurement Information System - Social Isolation(Pre-study and post-study (week 6))
  • Positive Affect in Differential Emotions Scale(Pre-study and post-study (week 6))
  • Negative Affect in Differential Emotions Scale(Pre-study and post-study (week 6))
  • Patient-Reported Outcomes Measurement Information System - Sleep Disturbance(Pre-study and post-study (week 6))

研究者

发起方
BrightOutcome
申办方类型
Industry
责任方
Principal Investigator
主要研究者

DerShung Yang, PhD

President

BrightOutcome

研究点 (2)

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