The Feasibility of Using a Mobile Application for Training and Support of Elder Caregivers
Phase: NA
Conditions: Caregivers, Technology
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
 
Digital Health Application for Training and Support of Elder Caregivers 
CLARE Mobile App 
 
Document Date: January 29, 2024 
 
NCT05877586 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
Our 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. Our training and support will focus on 
discharge care of patients including early mobility, and self-care among caregivers through walking 
activities.  We 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 our future work. 
 
 
Background & Significance 
 
In 2020, of the 53 million reported caregivers in the U.S., more than 10 million (19%) were aged 65 and 
above. Approximately two-thirds of individuals who required home caregiving (care-recipients) were 
older adults. Caregivers are considered the bedrock of homecare. Caregiving responsibilities are 
particularly heightened after hospital discharge when disease symptoms linger, and new care plans are 
initiated. Caregiving is critically important for older adults whose functional capacity is easily 
compromised due to hospitalization. Of approximately 33 million admitted to hospitals in 2020, 36% 
were older adults. The surge in technology has allowed healthcare to treat many chronic conditions in 
ambulatory settings. This means hospital admissions are reserved only for the sickest of sick. As the 
health acuity of admitted patients increases, upon discharge, their home caregivers will inevitably face 
more complex caregiving responsibilities. Yet, discharge practices have not changed much in more than 
three decades. Many hospitals still rely on patient/caregiver bedside teaching conducted mostly by 
nurses whose time and attention are understandably focused on caring for those still acutely ill. As a 
result, bedside discharge teaching has often been described as limited or rushed and many caregivers 
are left unprepared for their home caregiving responsibilities. Inadequately prepared caregivers often 
experience high levels of caregiving stress and often neglect their self-care. When caregivers are ill-
prepared for their caregiving role, it places their loved ones at high risk to receive inappropriate care. 
The increasing complexity in home caregiving and the rising number of caregivers create an impetus to 
discover new approaches to support and train caregivers. Our prior studies show that caregivers 
benefited from enhanced support and training for discharge care through increased levels in caregiving 
preparedness. However, our face-to-face approach in our studies hindered our ability to reach many 
caregivers, especially those with disproportionate numbers of negative social determinants of health 
such as living in rural areas, lack of access to transportation, and lack of leave opportunities at work. One 
viable solution to maximize reach and access to programs is the use of technology. In 2021, we piloted a 
virtual program for Covid caregivers using an embedded video training link sent by email. However, only 
54% of caregivers viewed our video. Most admitted that they were too preoccupied with patient care 
and household tasks to check emails. Rather, we noted caregivers responded quickly to text messages. 
Based on this experience and the extant literature on use of phone applications in patient care 
management, our team built CLARE, a digital health application that offers training and support to Covid 
caregivers.  

 
Design & Procedures 
 
Each caregiver will receive a unique invitation code to use the CLARE app. Our 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 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 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, we have included self-care strategies to manage anxiety and stress. For 
this pilot, we 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, we 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, 
we 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. We 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. We 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. We will encourage caregivers to use CLARE’s chat 
functionality to communicate with our team ad lib. We will promptly document and forward all medical 
questions to our hospital collaborators that include physicians, nurses, case managers, and 
physical/occupational therapists. 
 
 
Selection of Subjects 
  
To be eligible, caregivers must be the primary person who will aid patients at home after hospital 
discharge. Caregivers must be at least 35 years of age and provide care to a loved one who is also 55 
years and above. Caregivers must possess a smart phone or a tablet.   
 
In identifying subjects, we will implement the same process that we had used in our recent Covid 
caregiver training project. Our team will review patient roster at DUH at least twice weekly to identify 
patients, 55 years and above, admitted for Covid-related issues. Using the hospital text-messaging 
system, we will send text to corresponding admitting providers that we will call the emergency contact 
of patient as indicated in the patient's chart to determine if this person is the patient's caregiver. In the 
text to providers, we will provide a call back number and inform the provider that if we do not hear back 

from them within 24 hours, that we will proceed with making the telephone call. During our 
engagement call, we will verify if the emergency contact person is the patient's caregiver. In our 
previous caregiving trial on Covid, an overwhelming majority of emergency contact people were found 
to be patients' caregivers themselves. If the emergency contact person is the patient's caregiver, our 
team will ascertain that the caregiver is 35 years and above, and able to speak and read in English, and 
possess a smart phone. If yes to all, we will describe the study and allow caregiver to ask questions. If 
interested in participating but still undecided, we will plan for a follow-up call within 24 hours. If 
interested and ready to participate, we will obtain verbal consent.  
 
If the emergency contact person is not the patient's caregiver, we will ask the person if she/he knows of 
patient's caregiver. If yes, we will leave our contact telephone number with the emergency contact 
person to share with this caregiver. When the caregiver calls us, we will follow the same 
engagement/recruitment process described above.  
 
 
Subject Recruitment and Compensation 
 
Subject recruitment will follow the same workflow used in our recent Covid caregiver trial. Hospital 
providers will use the caregiver consult template we 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 our team receives the consult via Epic’s System List, our team will contact the caregiver by phone 
to assess eligibility and interest in participation. If interested, we will obtain verbal consent by phone. To 
begin caregiver training, the caregiver will receive an SMS link and/or e-mail to download the digital 
health application on their own smartphone or tablet. 
 
 
Consent Process 
  
Primary caregivers are individuals who have the capacity to provide assistance and care to patients 
(their loved ones) after hospital discharge. These are the caregivers that we will recruit to this pilot 
study. Thus, we do not anticipate any individuals with diminished capacity to be enrolled to our study.  
 
 
Risk/Benefit Assessment 
 
All recruitment procedures will comply with HIPAA and will receive approval from the Institutional 
Review Board at Duke University Medical Center. The consent process informs participants about the 
study, indicates the participation is voluntary and that he or she has the right to stop at any time. Risks 
are enumerated in the informed consent form and described orally during the consent process. Agreed 
wording for key messages during participant interactions, role plays, and explanatory materials will be 
developed. Recruitment and retention will be monitored; recruitment strategies will be adjusted in 
response to problems identified. Patients of all caregiver participants will continue to receive standard 
care provided by their health care providers at Duke University Hospital. Potential participants who 

meet eligibility criteria will be provided with written materials describing the study, its purposes, and its 
requirements. A member of the research team will conduct informed consent and explain all study 
procedures. 
 
Efforts will be made to reduce inconvenience to participants by scheduling assessments at times that are 
most convenient to them. Participants will be informed that they can withdraw from the study at any 
time for any reason. Protection of confidentiality will be accomplished by assigning each participant a 
distinct research code number and using this code number rather than the person’s name on all 
documents and electronic data acquired from the individual. Should there be hard copies containing 
data acquired from participants, they will be kept in locked files at the study site, and only this project's 
staff will have access to these files. No name or other unique identifiers will be included in any of the 
datasets used in the planned analyses of this project. The names, addresses, telephone numbers and 
other identifying information that correspond to study codes will be stored in a separate secured file. 
Access to this master file will be limited to study personnel on a “need to know” basis. All research staff 
will sign a statement of confidentiality indicating that all participant information is not to be discussed 
outside of the research setting. Importantly, all aspects of the trial that involve confidential patient 
information will be managed in accordance with HIPAA requirements. 
 
Study's participants will be caregivers (family and friends), 35 years and above, who will be the primary 
sources of assistance and care of elder patients with Covid at home after hospital discharge. Therefore, 
we will not be recruiting children, pregnant women, prisoners, or cognitively impaired individuals. 
 
There are several potential benefits to study participants. First, as the US population continues to age 
and survivorship from chronic diseases increases, the number of individuals living at home who require 
assistance will rise as well. Many of these caregiving responsibilities are assumed by the family and 
friends of these individuals. Without appropriate training and support provided to their caregivers, 
patients are at risk of receiving suboptimal care. Additionally, lack of preparedness in caregiving has 
been associated with a high degree of stress among caregivers. If successful, this pilot may provide 
another approach to support and training caregivers. Second, if deemed feasible, this caregiver app may 
augment discharge practices offered by hospitals in the country. With the average hospital days of care 
trending down in the past years, the care that patients need to promote recovery will be passed on to 
their caregivers. Thus, better trained and supported caregivers may lead to less adverse events 
happening after hospital discharge that may result in a decrease in avoidable healthcare utilization. 
Third, without support, many caregivers are at much higher risks to experience anxiety, depression, and 
burden. Providing training and support to caregivers during periods when caregiving is particularly 
challenging, such as during the hospital to home discharge, may mitigate some of the risks associated 
with psychological distress.  
 
If found feasible, the use of technology in caregiver support and training (i.e., CLARE app) has the 
potential to enhance access to valuable information and resources in home care. Better prepared 
caregivers in caregiving may lead to decrease in avoidable adverse events among patients after hospital 
discharge and may also promote caregiver well-being.  
 
 

Data Analysis & Statistical Considerations 
 
The proposed sample size of 50 is not based on formal power analysis, but a reasonable sample size to 
assess the feasibility of the intervention, the primary goal of the trial. This sample size should also be 
adequate to estimate the effect size and variation in outcomes that we need for future clinical trial 
planning. For this pilot, our quantitative variable for analysis is caregiving preparedness. 
 
Below describes our statistical plan and design related to the project aims. 
 
Aim 1: Feasibility of CLARE. Among eligible caregivers we have a goal of at least 60% enrollment rate.   
Among participants, we will examine engagement in CLARE by assessing the percentage of daily 
completed tasks.  We expect a minimum 60% completion rate per daily task for each caregiver. 
 
Aim 2: Intent and use of CLARE. Using Nvivo, we will look for themes of modifiable factors that can be 
enhanced to facilitate use of CLARE and barriers that can be eliminated. We will explore differences in 
themes of responses by caregiver gender and levels of experience and comfort in technology. To ensure 
credibility and dependability of analyses, two team members will perform thematic analysis. For 
validation, another team member will read 20% of transcripts. 
  
Aim 3 (exploratory): Impact of CLARE: We will calculate Cohen’s d in change in efficacy outcome 
between baseline and end of study participation in preparedness score in caregiving. We will also 
estimate the variability in change in this outcome, which can be used for power analysis for future 
efficacy testing in a randomized clinical trial. We will also assess the percentage of daily completed tasks 
in caregiver self-care and expect a minimum 60% completion rate per daily task for each caregiver.