ED PLWD/Care Partner Text Messaging

NCT07423871 | Not Yet Recruiting

• 3 other identifiers: 2000040692RFA-AG-24-0151K76AG094954-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Caregiver; Emergency Department; Mobile Health Technology (mHealth)

Outcome Measures

Primary Outcomes (5)

• Enrollment rates

  Enrollment rate will be used to assess Feasibility.

  30 days after ED visit

• Message engagement

  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.

  30 days after ED visit

• Retention rate

  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.

  30 days after ED visit

• System Usability Scale (SUS)

  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.

  30 days after ED visit

• Acceptability

  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.

  30 days after ED visit

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: CAPTURE Text Message Care Transition Support

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.

Interventions

CAPTURE Text Message Care Transition Support BEHAVIORAL

The CAPTURE intervention is a tailored, automated text messaging program designed to support care partners of persons living with cognitive impairment (PLWCI) during the 30-day period following an emergency department (ED) visit. It provides up to two messages per day, customized based on caregiver-identified needs, and addresses topics such as care transition guidance, symptom monitoring, caregiver well-being, community resources, and communication strategies. The content is evidence-informed and was developed through a user-centered design process involving caregivers and clinician stakeholders. Unlike generic text messaging interventions, CAPTURE specifically targets caregiver support needs in the acute post-ED setting for PLWCI.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Yale New Haven Hospital Emergency Departments

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Dementia; Emergencies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cameron Gettel

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron Gettel

CONTACT

2037374842; cameron.gettel@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: February 20, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)