CaregiversNCT05877586
CLARE Mobile App for Caregiver Training and Support
A study testing CLARE app in people with Caregivers and Technology, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Technology
- What is being tested?
- CLARE app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: The Feasibility of Using a Mobile Application for Training and Support of Elder Caregivers
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.
Read the detailed description
The proposed pilot 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, many of whom are elders themselves. The training and support will focus on discharge care of patients including early mobility, and self-care among caregivers through walking activities. The investigators have three study aims: (1) to test the feasibility of CLARE in caregiving training and support during the early days of hospital discharge; (2) to use the Unified Theory of Acceptance and Use of Technology behavioral framework (UTAUT) to determine factors that will promote intent and use of CLARE among elder caregivers; and (3) (exploratory) - to explore preliminary efficacy of CLARE in improving caregiving preparedness to inform effect size and variability in outcome for future work.
Each caregiver will receive a unique invitation code to use the CLARE app. 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. CLARE will feature materials on hospital discharge preparation, Covid care, and caregiver self-care, all vetted by the Duke University Health System (DUHS) Patient and Family Education department. Existing teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. Content will be reviewed and amended to reflect the latest Center for Disease Control (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 appointments with patient's primary care providers. For caregiver support, the investigators have included self-care strategies to manage anxiety and stress. For this pilot, the investigators will add two modules. The first additional module will pertain to the importance of early mobility of patients with instructions on how to assist based on functional capacity: independent, partial assistance, dependent. For example, for physically independent patients, the investigators will provide progressive distance walking activities from Day 1 to Day 7 (e.g., walking to sitting at the dining table to eat meals on Day 1 to walking around neighborhood as tolerated on Day 7). For patients needing partial assistance, the investigators will include body mechanics for caregivers as they assist patients during walking or from sitting to standing. And, for physically dependent patients, CLARE will provide teaching on passive range of motion for early day of discharge to progress to active range of motion. The second additional module will be for caregiver self-care. The investigators will include the importance of walking and provide daily reminders for activities that will involve walking. CLARE will provide caregiver training and support up to 7 days after hospital discharge. Seven days is intentional as post-hospital clinic visit frequently happens within this period where formal handoff of care from hospital to primary care occurs. The investigators will push daily task reminders in the morning followed by words of encouragement in the afternoon to hopefully sustain caregivers' motivation to continue using CLARE. The investigators will encourage caregivers to use CLARE's chat functionality to communicate with the study team ad lib. The investigators will promptly document and forward all medical questions to hospital collaborators that include physicians, nurses, case managers, and physical/occupational therapists.
To be eligible, caregivers must be the primary person who will aid patients at home after hospital discharge. Caregivers must be at least 65 years of age and provide care to a loved one who is also 65 years and above. Caregivers must possess a smart phone or a tablet. Caregivers will be selected by the healthcare team at Duke Hospital in units that have patients diagnosed with Covid-19. Caregivers must be able to speak and read in English.
Subject recruitment will follow the same workflow used in the team's recent Covid caregiver trial. Hospital providers will use the caregiver consult template the investigators developed in Epic once they have ascertained the presence of a caregiver on an elder patient admitted with a Covid diagnosis and planned discharge home. The consult template includes data points to collect caregiver names and contact information. Once the study team receives the consult via Epic's System List, the team will contact the caregiver by phone to assess eligibility and interest in participation. If interested, the investigators will obtain verbal consent by phone. To begin caregiver training, the caregiver will receive a short message service link (SMS) and/or e-mail to download the digital health application on their own smartphone or tablet.
- Conditions
- Caregivers, Technology
- Being tested
- CLARE app
- Keywords
- Caregivers, Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLARE appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers using CLARE app | Experimental | Caregiver participants in the study Receives: Other: CLARE app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Agreed to Participate
Measured: 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.
Measured: Daily up to study completion, an average of 10 days
Number of Participants Who Used CLARE Chat
Measured: 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)
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.
Measured: Study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start9 Oct 2023
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877586
- Sponsor's protocol ID
- PRO00111735
- Status last verified
- Nov 2025
- First submitted
- 15 Mar 2023
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data obtained from this feasibility study will not be placed or publicly stored for open availability. Given these data are meant to inform acceptability and feasibility of the caregiving app, the data are very specific to the intent of the pilot. As required by the NIH Policy on Dissemination of NIH-funded Clinical Trial Information, descriptive summaries and outcome data will be reported on clinicaltrials.gov. Products produced from this research including qualitative interview documents, qualitative codebooks for analysis, study protocols, and intervention design will follow the Template for Intervention Description and Replication guidelines and be made available online as supplemental appendices to publications and/or on the parent study (Duke Roybal Center) website.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using a Mobile Application for Training and Support of Elder Caregivers
- ClinicalTrials.gov ID
- NCT05877586
- Acronym / sponsor ID
- PRO00111735
- Conditions
- Caregivers, Technology
- Keywords
- Caregivers, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed pilot 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, many of whom are elders themselves. The training and support will focus on discharge care of patients including early mobility, and self-care among caregivers through walking activities. The investigators have three study aims: (1) to test the feasibility of CLARE in caregiving training and support during the early days of hospital discharge; (2) to use the Unified Theory of Acceptance and Use of Technology behavioral framework (UTAUT) to determine factors that will promote intent and use of CLARE among elder caregivers; and (3) (exploratory) - to explore preliminary efficacy of CLARE in improving caregiving preparedness to inform effect size and variability in outcome for future work.
Each caregiver will receive a unique invitation code to use the CLARE app. 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. CLARE will feature materials on hospital discharge preparation, Covid care, and caregiver self-care, all vetted by the Duke University Health System (DUHS) Patient and Family Education department. Existing teaching on Covid covers isolation; quarantine; home sanitization; and monitoring for Covid symptoms such as cough, fever, fatigue, and shortness of breath. Content will be reviewed and amended to reflect the latest Center for Disease Control (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 appointments with patient's primary care providers. For caregiver support, the investigators have included self-care strategies to manage anxiety and stress. For this pilot, the investigators will add two modules. The first additional module will pertain to the importance of early mobility of patients with instructions on how to assist based on functional capacity: independent, partial assistance, dependent. For example, for physically independent patients, the investigators will provide progressive distance walking activities from Day 1 to Day 7 (e.g., walking to sitting at the dining table to eat meals on Day 1 to walking around neighborhood as tolerated on Day 7). For patients needing partial assistance, the investigators will include body mechanics for caregivers as they assist patients during walking or from sitting to standing. And, for physically dependent patients, CLARE will provide teaching on passive range of motion for early day of discharge to progress to active range of motion. The second additional module will be for caregiver self-care. The investigators will include the importance of walking and provide daily reminders for activities that will involve walking. CLARE will provide caregiver training and support up to 7 days after hospital discharge. Seven days is intentional as post-hospital clinic visit frequently happens within this period where formal handoff of care from hospital to primary care occurs. The investigators will push daily task reminders in the morning followed by words of encouragement in the afternoon to hopefully sustain caregivers' motivation to continue using CLARE. The investigators will encourage caregivers to use CLARE's chat functionality to communicate with the study team ad lib. The investigators will promptly document and forward all medical questions to hospital collaborators that include physicians, nurses, case managers, and physical/occupational therapists.
To be eligible, caregivers must be the primary person who will aid patients at home after hospital discharge. Caregivers must be at least 65 years of age and provide care to a loved one who is also 65 years and above. Caregivers must possess a smart phone or a tablet. Caregivers will be selected by the healthcare team at Duke Hospital in units that have patients diagnosed with Covid-19. Caregivers must be able to speak and read in English.
Subject recruitment will follow the same workflow used in the team's recent Covid caregiver trial. Hospital providers will use the caregiver consult template the investigators developed in Epic once they have ascertained the presence of a caregiver on an elder patient admitted with a Covid diagnosis and planned discharge home. The consult template includes data points to collect caregiver names and contact information. Once the study team receives the consult via Epic's System List, the team will contact the caregiver by phone to assess eligibility and interest in participation. If interested, the investigators will obtain verbal consent by phone. To begin caregiver training, the caregiver will receive a short message service link (SMS) and/or e-mail to download the digital health application on their own smartphone or tablet.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caregivers using CLARE app | Experimental | Other: CLARE appCaregiver participants in the study |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLARE appCLARE 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. | Other | Caregivers using CLARE app |
Primary outcome
Number of Participants Who Agreed to Participate
Time frame: Day 1
Percentage of CLARE App Tasks Completed
Time frame: 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.
Number of Participants Who Used CLARE Chat
Time frame: Up to study completion, an average of 10 days
1 secondary outcome
Impact of CLARE as Measured by the Number of Participants Considered Prepared by the Preparedness in Caregiving Scale (PCS)
Time frame: Study completion, an average of 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data obtained from this feasibility study will not be placed or publicly stored for open availability. Given these data are meant to inform acceptability and feasibility of the caregiving app, the data are very specific to the intent of the pilot. As required by the NIH Policy on Dissemination of NIH-funded Clinical Trial Information, descriptive summaries and outcome data will be reported on clinicaltrials.gov. Products produced from this research including qualitative interview documents, qualitative codebooks for analysis, study protocols, and intervention design will follow the Template for Intervention Description and Replication guidelines and be made available online as supplemental appendices to publications and/or on the parent study (Duke Roybal Center) website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLARE app in people with Caregivers and Technology, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Agreed to Participate (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.