Trial Outcomes & Findings for CLARE Mobile App for Caregiver Training and Support (NCT NCT05877586)

NCT ID: NCT05877586

Last Updated: 2025-11-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2025-11-18

Participant Flow

Only caregivers were considered enrolled. Their associated patients were not considered enrolled.

Participant milestones

Measure	Caregivers Using CLARE App Caregiver participants in the study CLARE app: CLARE will contain materials on hospital discharge preparation, Covid care, and caregiver self-care, all of which have already been vetted by the DUHS Patient and Family Education department. Existing CLARE teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. All will be reviewed and amended to reflect the latest CDC guidelines for Covid care at the time of pilot implementation. CLARE will also include reminders on examining the After-Visit-Summary to determine home medications and information on follow-up care. CLARE will push training and support messages to caregivers that can be delivered before hospital discharge and daily for seven days after discharge or when patient is seen by a provider after hospitalization, whichever comes first.
Overall Study STARTED	50
Overall Study Used the App	37
Overall Study Pre-discharge and Post-discharge Use of App	21
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CLARE Mobile App for Caregiver Training and Support

Baseline characteristics by cohort

Measure	Caregivers Using CLARE App n=50 Participants Caregiver participants in the study CLARE app: CLARE will contain materials on hospital discharge preparation, Covid care, and caregiver self-care, all of which have already been vetted by the DUHS Patient and Family Education department. Existing CLARE teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. All will be reviewed and amended to reflect the latest CDC guidelines for Covid care at the time of pilot implementation. CLARE will also include reminders on examining the After-Visit-Summary to determine home medications and information on follow-up care. CLARE will push training and support messages to caregivers that can be delivered before hospital discharge and daily for seven days after discharge or when patient is seen by a provider after hospitalization, whichever comes first.
Age, Continuous	62.0 years STANDARD_DEVIATION 11.5 • n=202 Participants
Sex: Female, Male Female	41 Participants n=202 Participants
Sex: Female, Male Male	9 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	0 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	8 Participants n=202 Participants
Race (NIH/OMB) White	15 Participants n=202 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=202 Participants
Region of Enrollment United States	50 Participants n=202 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Individuals who were approached for the study. Only caregivers were considered enrolled; no data was collected on their associated patients.

Outcome measures

Measure

Caregivers Using CLARE App n=65 Participants Caregiver participants in the study CLARE app: CLARE will contain materials on hospital discharge preparation, Covid care, and caregiver self-care, all of which have already been vetted by the DUHS Patient and Family Education department. Existing CLARE teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. All will be reviewed and amended to reflect the latest CDC guidelines for Covid care at the time of pilot implementation. CLARE will also include reminders on examining the After-Visit-Summary to determine home medications and information on follow-up care. CLARE will push training and support messages to caregivers that can be delivered before hospital discharge and daily for seven days after discharge or when patient is seen by a provider after hospitalization, whichever comes first.

Number of Participants Who Agreed to Participate

50 Participants

PRIMARY outcome

Timeframe: Daily up to study completion, an average of 10 days

CLARE app tasks were released at 7:00 AM and 6:00 PM daily. Calculated as the total number of completed tasks for all participants divided by the total number of available tasks for all participants x 100.

Outcome measures

Measure	Caregivers Using CLARE App n=50 Participants Caregiver participants in the study CLARE app: CLARE will contain materials on hospital discharge preparation, Covid care, and caregiver self-care, all of which have already been vetted by the DUHS Patient and Family Education department. Existing CLARE teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. All will be reviewed and amended to reflect the latest CDC guidelines for Covid care at the time of pilot implementation. CLARE will also include reminders on examining the After-Visit-Summary to determine home medications and information on follow-up care. CLARE will push training and support messages to caregivers that can be delivered before hospital discharge and daily for seven days after discharge or when patient is seen by a provider after hospitalization, whichever comes first.
Percentage of CLARE App Tasks Completed Tasks released at 7:00 AM	65.6 percentage of tasks
Percentage of CLARE App Tasks Completed Tasks released at 6:00 PM	16.6 percentage of tasks

PRIMARY outcome

Timeframe: Up to study completion, an average of 10 days

Population: Data not collected. The chat feature was never activated due to a personnel issue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study completion, an average of 10 days

Population: Participants with PCS data collected.

Preparedness in Caregiving Scale (Stewart and Archbold, 1986) with an added item in self-care mobility (total possible score is 36; higher scores denote better outcomes). Reported as the number of participants who demonstrated improved preparedness.

Outcome measures

Measure

Caregivers Using CLARE App n=10 Participants Caregiver participants in the study CLARE app: CLARE will contain materials on hospital discharge preparation, Covid care, and caregiver self-care, all of which have already been vetted by the DUHS Patient and Family Education department. Existing CLARE teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. All will be reviewed and amended to reflect the latest CDC guidelines for Covid care at the time of pilot implementation. CLARE will also include reminders on examining the After-Visit-Summary to determine home medications and information on follow-up care. CLARE will push training and support messages to caregivers that can be delivered before hospital discharge and daily for seven days after discharge or when patient is seen by a provider after hospitalization, whichever comes first.

Impact of CLARE as Measured by the Number of Participants Considered Prepared by the Preparedness in Caregiving Scale (PCS)

6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Study completion, an average of 10 days

Interview questions about performance expectancy, effort expectancy, social influence, and facilitating conditions on information technology.

Outcome measures

Outcome data not reported

Adverse Events

Caregivers Using CLARE App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cristina C. Hendrix, DNS, GNP, FAAN

Duke University

Phone: 919-684-9358

Email: cristina.hendrix@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place