CLARE Mobile App for Caregiver Training and Support

NCT05877586 | Completed Results

• 1 other identifier: PRO00111735
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will investigate the feasibility of using a digital health application, Communication, Learning, Advocacy, Resources and Expertise (CLARE), in training and support of family and friends (i.e., caregivers) of older adults with Covid in home caregiving, and in their self-care. The study's mixed method, one group, pre-post design will recruit 50 caregivers who are at least 65 years of age at Duke University Hospital. Caregivers must be the primary person who will aid patients at home after hospital discharge. The caregiver will receive a short message service (SMS) link and/or e-mail to download the digital health application on their own smartphone or tablet. The study team will guide the caregiver through features of the application including how to complete demographics questionnaire and surveys for caregiving preparedness, and how to reply to reminders. For data collection, the investigators will use CLARE analytics for feasibility analysis, interview data to determine modifiable factors that will enhance CLARE use, and pre-post preparedness in caregiving data to explore preliminary efficacy of CLARE.

Conditions

Caregivers; Technology

Keywords

Caregivers; Technology

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Agreed to Participate

  Day 1

• Percentage of CLARE App Tasks Completed

  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.

  Daily up to study completion, an average of 10 days

• Number of Participants Who Used CLARE Chat

  Up to study completion, an average of 10 days

Secondary Outcomes (1)

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

  Study completion, an average of 10 days

Other Outcomes (1)

• Intent and Use of CLARE

  Study completion, an average of 10 days

Study Arms (1)

Caregivers using CLARE app

EXPERIMENTAL

Caregiver participants in the study

Other: CLARE app

Interventions

CLARE app OTHER

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 have two sessions of training and support to caregivers that can be delivered before hospital discharge and daily for seven days after discharge.

Caregivers using CLARE app

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers must be the primary person assisting patients at home after hospital discharge.
• Caregivers must be at least 35 years of age.
• Caregivers must provide care to a loved one who is 55 years and above.
• Caregivers must possess a smartphone or a tablet.

You may not qualify if:

• Caregivers who are not the primary person assisting patients at home after hospital discharge.
• Caregivers who are younger than 35 years old.
• Caregivers who are caring for a patient younger than 55 years old.
• Caregivers who do not possess a smartphone or a tablet.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Cristina C. Hendrix, DNS, GNP, FAAN
• Organization: Duke University

cristina.hendrix@duke.edu

919-684-9358

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each caregiver will receive a unique invitation code to use the CLARE app. The study team will guide the caregiver through the features of the application. CLARE will provide caregiver training and support up to 7 days after hospital discharge.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 26, 2023
• Study Start: October 9, 2023
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)