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临床试验/NCT07423871
NCT07423871尚未招募不适用

Development and Pilot Testing of a Novel Text Messaging Intervention to Improve Emergency Department Care Transitions Among Care Partners of Persons Living With Cognitive Impairment

Yale University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2027年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Enrollment rates

研究概览

简要总结

The purpose of this research study is to develop and test a text-messaging intervention for emergency department (ED) discharge care transitions experienced by caregivers of older adults with cognitive impairment.

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 partners (family members or close contacts) of persons living with cognitive impairment (PLWCI) who were evaluated and discharged from the emergency department (ED)
  • Age 18 years or older
  • Able to read and understand English or Spanish
  • Owns a mobile phone capable of receiving SMS text messages
  • Provides informed consent to participate in the study
  • Care recipient (PLWCI) resides in a community setting (i.e., not in a long-term care facility)

排除标准

  • Care partner of a patient who is admitted to the hospital from the ED or transferred to a facility (e.g., skilled nursing facility)
  • Care partner who is already enrolled in another caregiving support trial or intervention study
  • Care partner who does not have regular access to a mobile phone with SMS capabilities
  • Care partner who is unable or unwilling to participate in follow-up over 30 days
  • Care partner of a patient enrolled in hospice or receiving end-of-life care

研究组 & 干预措施

Intervention

Experimental

Participants in the intervention arm will receive the CAPTURE intervention, a tailored, automated text messaging program designed to support care partners of persons living with cognitive impairment (PLWCI) during the 30 days following an emergency department (ED) discharge. The intervention delivers up to two daily SMS messages focused on caregiving tips, care transition guidance, emotional support, and links to trusted resources. Messages are personalized based on caregiver needs identified at baseline and are designed to be brief, accessible, and actionable. Content was developed using a user-centered design approach with input from caregivers and clinicians. Participants will also complete a baseline and 30-day follow-up survey to assess caregiver preparedness, usability, satisfaction, and engagement.

干预措施: CAPTURE Text Message Care Transition Support (Behavioral)

Control

No Intervention

Participants in the control arm will receive usual care following the emergency department (ED) discharge of the person living with cognitive impairment (PLWCI). Usual care may include standard discharge instructions provided by ED staff, referrals to outpatient services, and any follow-up arranged as part of routine clinical practice. No additional caregiver-specific interventions or text messaging support will be provided by the study team. Participants in this arm will complete a baseline and 30-day follow-up survey to assess caregiver preparedness, usability, satisfaction, and engagement for comparison with the intervention arm.

结局指标

主要结局

Enrollment rates

时间窗: 30 days after ED visit

Enrollment rate will be used to assess Feasibility.

Message engagement

时间窗: 30 days after ED visit

Message engagement, assessed via text message response and interaction metrics, will be used to assess Feasibility. Engagement will be operationalized through quantitative metrics including (1) the number of text messages delivered, (2) the number and proportion of text messages that received responses from care partners, (3) the time-to-response for interactive messages, and (4) the number of unique interactions per participant over the 30-day intervention period. These metrics will be captured via backend system logs of the text messaging platform used to deliver the intervention.

Retention rate

时间窗: 30 days after ED visit

Participant retention at 30 days post-enrollment, assessed through completion of final follow-up assessment Retention is defined as the proportion of enrolled care partners who remain active in the study and complete the 30-day follow-up assessment. Completion is operationalized as successfully providing outcome data through a structured telephone-based survey at the end of the 30-day intervention period. This includes response to caregiver-reported outcome measures collected by the research team (e.g., burden, satisfaction, preparedness). Retention rate will be calculated as a percentage: (# of participants who complete the 30-day follow-up ÷ total number enrolled) × 100. Participants lost to follow-up or who withdraw consent prior to completing the final assessment will be considered non-retained.

System Usability Scale (SUS)

时间窗: 30 days after ED visit

The System Usability Scale (SUS) will be used to assess the usability of the CAPTURE text message intervention. The SUS is a validated 10-item questionnaire that measures perceived ease of use, efficiency, and satisfaction with a digital system. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), and item scores are converted to yield a total score ranging from 0 to 100, with higher scores indicating better usability. The SUS total score will be calculated for each participant at the 30-day follow-up. Mean and distributional statistics will be reported for the intervention group.

Acceptability

时间窗: 30 days after ED visit

Acceptability of the CAPTURE text message intervention will be assessed through a structured participant satisfaction survey and open-ended qualitative feedback. The survey includes multiple items rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with higher scores indicating greater acceptability and satisfaction. Domains assessed include overall satisfaction, perceived helpfulness, relevance, and willingness to recommend the intervention to others. In addition, participants will be invited to provide brief qualitative comments via open-ended items assessing their experience and suggestions for improvement. Quantitative results will be summarized using descriptive statistics, and qualitative feedback will be analyzed using thematic content analysis.

次要结局

  • Preparedness for Caregiving Scale(30 days after ED visit)
  • Zarit Burden Interview score(30 days after ED visit)
  • Emergency Department revisits and hospitalizations(30 days after ED visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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