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临床试验/NCT06167746
NCT06167746招募中3 期

Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools

University of Pennsylvania3 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
314
试验地点
3
主要终点
Health Self-Care Neglect

研究概览

简要总结

The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are:

  1. compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home,
  2. compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and
  3. explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone.

Participants who enroll will agree to enroll will:

  • be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and
  • be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment.

Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Investigator)

盲法说明

The Principal Investigator will be blinded to group assignment.

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

  • Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older)
  • Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2)
  • Willing to use technology (e.g., computer, smartphone, iPad/tablet)
  • Able to complete the protocol, e.g., adequate vision and hearing
  • English speaking

排除标准

  • Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)
  • Participation in another similar support or care transition trial
  • Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)

研究组 & 干预措施

Digital Health Information (DHI)

Active Comparator

Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study.

干预措施: Digital Health Information (DHI) (Other)

Virtual Health Coaching + DHI

Experimental

Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.

干预措施: Digital Health Information (DHI) (Other)

Virtual Health Coaching + DHI

Experimental

Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.

干预措施: Virtual Health Coach for You (Behavioral)

结局指标

主要结局

Health Self-Care Neglect

时间窗: Collected at: enrollment, 3- and 6-months after enrollment

This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.

Self-Care Inventory

时间窗: Collected at: enrollment, 3- and 6-months after enrollment

The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care.

次要结局

  • Preparedness for Caregiving Scale(Collected at: enrollment, 3- and 6-months after enrollment)
  • RAND Medical Outcomes Study Short Form (SF-36)(Collected at: enrollment, 3- and 6-months after enrollment)
  • Brief COPE(Collected at: enrollment, 3- and 6-months after enrollment)
  • Perceived Stress Scale(Collected at: enrollment, 3- and 6-months after enrollment)
  • Caregiver Self-Care Self-Efficacy Scale(Collected at: enrollment, 3- and 6-months after enrollment)
  • Quality of the relationship(Collected at: enrollment, 3- and 6-months after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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