- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423871
ED PLWD/Care Partner Text Messaging (CAPTURE)
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cameron Gettel
- Phone Number: 2037374842
- Email: cameron.gettel@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale New Haven Hospital Emergency Departments
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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.
|
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment rates
Time Frame: 30 days after ED visit
|
Enrollment rate will be used to assess Feasibility.
|
30 days after ED visit
|
|
Message engagement
Time Frame: 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. |
30 days after ED visit
|
|
Retention rate
Time Frame: 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. |
30 days after ED visit
|
|
System Usability Scale (SUS)
Time Frame: 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. |
30 days after ED visit
|
|
Acceptability
Time Frame: 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. |
30 days after ED visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preparedness for Caregiving Scale
Time Frame: 30 days after ED visit
|
Preparedness for Caregiving Scale to assess Care partner preparedness.
Total score range 0 to 32.
Higher scores indicate greater perceived readiness for caregiving.
|
30 days after ED visit
|
|
Zarit Burden Interview score
Time Frame: 30 days after ED visit
|
Zarit Burden Interview, self-efficacy scales used to assess Emotional well-being and burden.
Total score 0-88, higher scores indicate more severe burden.
|
30 days after ED visit
|
|
Emergency Department revisits and hospitalizations
Time Frame: 30 days after ED visit
|
Return healthcare utilization assessed as mean number ED revisits
|
30 days after ED visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cameron Gettel, Yale University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000040692
- RFA-AG-24-015 (Other Grant/Funding Number: National Institute on Aging)
- 1K76AG094954-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
Benjamin Rose Institute on AgingNational Institute on Aging (NIA)RecruitingMild Dementia | Moderate DementiaUnited States
-
Yaolin PeiNational Institutes of Health (NIH)RecruitingEnd of Life Decision Making | Dementia Caregivers | Advanced DementiaUnited States
-
Benuvia Therapeutics Inc.MandaraNot yet recruiting
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityCompletedDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeActive, not recruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
The University of Hong KongNot yet recruiting
-
Temple UniversityCompletedDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
Clinical Trials on CAPTURE Text Message Care Transition Support
-
University of Colorado, DenverNational Cancer Institute (NCI); Massachusetts General Hospital; Dana-Farber... and other collaboratorsNot yet recruitingColorectal CancerUnited States
-
University of Auckland, New ZealandHealth Research Council, New ZealandCompletedObesity | Bariatric Surgery CandidateNew Zealand
-
Yaounde Central HospitalCIHR Canadian HIV Trials NetworkCompleted
-
Marmara UniversityNot yet recruitingMidwifery Students
-
Denver Health and Hospital AuthorityCenter for Health Systems Research at Denver Health; Colorado Health Outcomes...CompletedBody Weight | Body Weight Changes | Prediabetic State | PrediabetesUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Recruiting
-
University of Maryland, BaltimoreMerck Sharp & Dohme LLCTerminatedHPV VaccinesUnited States
-
Kuopio University HospitalCentral Finland Hospital District; Health Centre of Jyväskylä Cooperation Area and other collaboratorsCompletedHypertension | Blood Pressure | Medication Adherence | Patient Compliance | Patient AdherenceFinland
-
Karolinska InstitutetForteCompletedStroke | Transient Ischemic AttackSweden
-
University of NottinghamCompletedSmoking Cessation | Pregnancy RelatedUnited Kingdom