Translating a Dementia Caregiver Intervention Into a Mobile Application
Phase: NA
Conditions: Dementia, Alzheimer Disease, Caregiver Burnout
Sponsor: Rhode Island Hospital

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Translating a Dementia Caregiver Intervention Into a Mobile Application 
 
NCT04330482 
9/22/2020 
 
 

SPECIFIC AIMS 
The overall goal of this development project is to combine elements of two interventions 
into a mobile health (mHealth) App for informal dementia caregivers. Caring for a person with 
dementia is a highly stressful activity and is associated with negative physical and mental health 
consequences, including increased risk of depression and worse reported health-related quality 
of life (1). There is currently no effective disease-modifying treatment for Alzheimer’s disease 
(AD) and related dementias, and 70% of persons with AD are cared for by family members or 
other informal caregivers (2). There is a pressing need for strategies to care for both the 
increasing population of dementia patients and their family caregivers. Psychosocial 
interventions (particularly multicomponent interventions) for dementia caregivers are successful 
in reducing depression, stress, and burden associated with caregiving and delaying nursing 
home placement (3-6). Although over 200 dementia caregiver interventions have been found 
efficacious in randomized trials, less than 3% of interventions have been empirically tested in 
translational studies (7). As a result, family caregivers do not receive intervention strategies 
shown to be most effective. The few translational studies that exist demonstrate that complex 
trials from randomized interventions can be adapted for community implementation and tend to 
obtain similar results seen in RCTs (8,9). One method for widespread dissemination and 
scalability of an intervention is technology-based approaches, such as mHealth Apps.  
Our research group developed the Family Intervention: Telephone Tracking Caregiver 
(FITT-C), which is an entirely telephone-delivered psychosocial intervention (R21MH062561). A 
full-scale efficacy study (R01NR010559; [10]) showed that compared to a supportive 
intervention, the FITT-C reduced caregiver depressive symptoms and their reactions to patient 
memory and behavior problems. A secondary analysis revealed that FITT-C caregivers had 
lower healthcare utilization and greater community resource use compared to support 
caregivers (11). Our team also conducted an RCT of a mind-body intervention (i.e., yoga, 
meditation) in individuals with depressive symptoms (R01NR012005; [12]), which showed 
reduced depressive symptoms at 6-month follow-up compared to a health education program. 
The proposed study will combine and translate each of these interventions into a mHealth App 
(CARE-Well [Caregiver Assessment, Resources, and Education]). A strength of the proposed 
project is merging these complementary interventions to provide caregivers with a range of 
empirically-supported opportunities for psychoeducation, stress management, and problem 
solving.  
Aim 1: Develop and preliminarily test a mHealth tablet App for dementia caregivers 
incorporating important elements of FITT-C and a mind-body (yoga, meditation) intervention. 
 
Collaborate with a computer/biomedical engineering team with an expertise in mHealth 
technologies to integrate key components of both interventions and develop a beta 
version of the App for initial testing. 
 
Conduct a month-long open trial of the App in 10 dementia caregivers and elicit 
feedback about the App using qualitative interviews.  
Aim 2: Conduct a feasibility trial of the newly-developed CARE-Well App in 40 dementia 
caregivers to establish acceptability and feasibility of the intervention, study procedures, and 
outcome measures. 
The current proposal aligns well with NIH priorities as outlined in PAR-18-179, including 
development of novel interventions to meet needs of caregivers and leveraging technology to 
support caregivers in the home. The recent 2015 Alzheimer’s Disease Summit recommended 
initiating programs that bring together cross-disciplinary expertise to develop more personalized 
technologies to serve the diverse populations of aging adults with and without AD and their 
caregivers. The overarching goal of this application is to develop a highly transportable and 
scalable intervention for dementia caregivers that can be tested in a future clinical trial.  
 
 

RESEARCH STRATEGY 
SIGNIFICANCE 
AD currently affects 5.7 million people in the U.S. (2). There is currently no effective 
disease modifying treatment for AD, and most pharmaceutical trials for the disease failed, 
suggesting that we are still far from an effective treatment. Dementia caregivers are the main 
support source for these individuals, with over 70% of individuals with AD cared for by family 
members or other informal caregivers (2). Dementia caregivers are at heightened risk for 
depression, anxiety, stress, and other negative health consequences (1, 13-14). It is therefore 
important to develop interventions for this high-risk group. Psychosocial interventions for 
dementia caregivers are successful in reducing depression, stress, and burden associated with 
caregiving and delaying nursing home placement (3, 5, 10). In addition, there is evidence that 
multicomponent interventions are most efficacious compared to single-focused approaches in 
treating the negative effects of caregiving and delaying institutionalization of the care recipient 
(3,5). Individual and tailored interventions for caregivers are also more effective than group and 
one-size-fits-all models (15). 
Although over 200 dementia caregiver interventions have been found efficacious in 
randomized trials, less than 3% of interventions have been empirically tested in translational 
studies (7). As a result, family caregivers do not receive intervention strategies shown to be 
most effective. Barriers to implementation of multicomponent interventions (even those 
delivered by telephone) include high cost, personnel time, and limited accessibility. Caregivers 
also encounter numerous barriers related to in-person programs and support groups, such as 
limited transportation, time pressures of caregiving, inability to find care for the recipient, lack of 
knowledge of services, reluctance, or stigma associated with seeking support. Consequently, 
dementia caregivers tend to underutilize community support services and other resources (16).  
MHealth Apps are a particularly promising strategy to meet caregivers’ needs that are 
accessible during convenient times. Mobile and web-based interventions show promise in 
specific skill building for dementia caregivers (17), lessening burden in cancer caregivers (18) 
and reducing depressive symptoms in adults with mental illness (19). Many of these studies are 
plagued by methodological limitations, involving inadequate controls, lack of blinding, and 
limited descriptions of methods (20). The proposed project aims to address these 
limitations by developing and translating an evidence-based, multi-component 
intervention into a mHealth App that has the potential to increase dementia caregivers’ 
access to support and care. 
 
Conceptual Framework. The FITT-C intervention is based on a combination of 
theoretical models, including psychosocial transitions (21), transactional stress and coping (22), 
and the McMaster Model of Family Functioning (23). These models propose that dementia 
caregiving consists of stress-inducing events that result in an appraisal process by the caregiver 
to identify whether resources are available to cope with the events. Caregiver burden can be 
viewed as a situation in which subjective and objective demands exceed subjective and 
objective coping and resources, and persisting burden becomes a stressor that results in 
feelings of depression and helplessness. The focus of the intervention is on increasing caregiver 
coping through active problem-solving skill development and promoting positive changes within 
the family system. As such, the FITT-C intervention directly targets caregiver appraisal and 
coping, and has shown reductions in burden, depression, and reactions to memory and 
behavior problems in dementia caregivers (10). The framework underlying the mind-body 
intervention involves multiple components (physical activity/postures, breathing exercises, and 
meditation) that target depressive symptoms and may decrease rumination. Yoga and 
meditation are efficacious in reducing depression (12), reducing anxiety (24) and may amplify 
the FITT-C intervention by providing additional stress management techniques for relaxation 
and mindfulness that can be applied in daily life. The negative effects of dementia caregiving 
are broad and complex and may be best addressed by a multipronged approach, such as 

increasing coping skills and reducing stress, depression, burden, reactions to behavioral 
problems, and rumination/worry.  
 
INNOVATION 
The current project represents the first study to develop a combined psychosocial and mind-
body intervention based on evidence-based programs that show reduction in the negative 
consequences of dementia caregiving and depression and rumination. The project will create 
and test a multicomponent, mHealth App rather than a specific educational or skill building 
approach. The design of the App will allow for: 1) tailoring and personalizing the intervention 
based on caregiver assessment; 2) using conceptual frameworks of the interventions in 
developing the App, 3) including current dementia caregivers in the process of refining and 
adapting the intervention; and 4) developing a cross-disciplinary collaboration between 
computer engineers and clinical researchers. Given the widespread availability of mobile 
devices, the intervention has the potential for efficient dissemination into the community 
following demonstration of efficacy.   
 
APPROACH 
Overview. This project will translate the FITT-C and mind-body interventions into a 
mHealth App through a collaboration between clinical and computer engineering scientists. In 
Aim 1, we will develop the mHealth App and use participatory research methods to modify the 
App. In Aim 2, we will conduct a feasibility study in 40 dementia caregivers to establish 
acceptability and feasibility of the intervention, study procedures, and outcome measures. If the 
aims are achieved, we will have a fully-developed mHealth App and established feasibility for 
procedures to conduct a full-scale RCT. Another goal of this project is to demonstrate viability of 
translating in-person interventions into mHealth Apps. The proposed study includes Stage 1a 
(intervention modification) and Stage 1b (feasibility and pilot testing the App).  
Preliminary Studies. The PI (Tremont) developed the Family Intervention: Telephone 
Tracking intervention (R21MH062561; [6]) and demonstrated efficacy of the intervention 
(R01NR010559; [10]), showing that compared to a supportive intervention, the FITT-C reduced 
caregiver depressive symptoms and their reactions to patient memory and behavior problems. A 
recent secondary analysis showed that the FITT-C reduced ER visits and hospital stays among 
caregivers and increased the use of community resources compared to a supportive 
intervention (11). We have a detailed treatment manual that includes sample dialogue, 
intervention strategies, and strategies for management common behavioral problems in 
dementia that will available for use in the current study. The PI and other members of our 
research group also developed a mind-body intervention that we tested in a randomized clinical 
trial in 122 individuals with depressive symptoms who were taking antidepressant medications 
(R01NR012005; [12]). Results showed that the 10-week intervention reduced depressive 
symptoms at 6-month follow-up compared to a healthy living educational program. As part of 
developing this project, we started a collaboration with the computer/biomedical engineering 
group from the University of Rhode Island (URI; led by Dr. Kunal Mankodiya serving as a Co-I in 
this proposal). Mankodiya’s team has developed and deployed a number of mHealth 
technologies  with medical and psychiatric patients including SPARK (25), EchoWear (26-28), 
Android EAR (29-31), and Face Emotion Monitoring (32,33). Overall, our multidisciplinary 
research team is uniquely positioned to conduct this study.  
Aim 1 Approach. We will work closely with computer engineering scientists at URI to 
translate the caregiver and mind-body interventions into a mobile App. We will then beta test the 
App in 10 dementia caregivers for one month. Specific recommendations from these caregivers 
will be obtained via individual qualitative interviews and questionnaires measuring technical 
issues and content use. Based on this information, the App will be expanded, modified, and 
translated to be a more effective and user-friendly tool. The research team will meet weekly 

over nine months to review progress and provide input about content and functionality of the 
App. For both interventions, we have detailed treatment manuals that will be used to identify 
specific content.  
Phase 1. Translation of intervention. In this step (6 months), we will work with Co-I 
Mankodiya to design the App and add intervention content. In preliminary discussions, we have 
identified equipment needed for the study and developed a preliminary outline of the App 
components (see below and Figure 1).  
Technical issues. The mHealth App will be designed for the android platform. We chose this 
platform because of simplicity in implementation and time and financial limitations of the current 
award. Future projects will allow for development for other platforms including iOS (iPad or 
iPhone). In addition, we chose to provide all participants in the study with android tablets to 
standardize operating procedures and minimize troubleshooting of multiple personal devices. 
We will restrict participants’ access within the tablet to the CARE-Well, Gmail, and Zoom Apps 
only. Future projects will incorporate personal devices to increase accessibility and applicability 
of the intervention. All App data will be stored on participants’ tablet devices but will not include 
any personal or health information. At completion of each study phase, data will be downloaded 
into a password-protected database for analysis. The message forum (described below) will 
involve a Google group that is embedded in the App. Mankodiya’s team at URI will provide 
technical support for participants and will develop troubleshooting procedures but will not have 
access to personal or health information. Our partner will also develop an orientation training 
and video about how to use the App.   
Intervention Description. The overall intent of the CARE-Well mobile App is to replicate the 
content and strategies in the telephone-based FITT-C intervention and to integrate the 
mindfulness and meditation exercises with FITT-C components (see Table 1). Caregivers will be 
encouraged to use the App at least four times per week. Caregivers will be prompted to 
complete an in-App, weekly assessment of key areas (i.e., family functioning, health, mood, 
social support, and care recipient behavior problems) that will allow for tailoring of intervention 
components.  As caregivers complete recommended components, they will receive rewards 
within the App. Reminders will be used to increase accountability for tasks assigned and for 
recommended readings. Embedded in the App will be an online caregiver community (Google 
group), in which caregivers can anonymously post and respond to messages under a username 
that is in no way connected to personal Gmail accounts. The research team will recommend 
against posting any personal or identifying information; however, it is ultimately up to the 
participant to decide whether or not they want to post more personal information. The Google 
group will be monitored by the research team who may also provide comments, corrections, and 
links to helpful material. Allowing caregivers to respond to each other will provide social support 
and identify content that could be added to the App. Other App components will include:    
 
Psychoeducation – general education about dementia and caregiving; educational 
components about family functioning, healthy living strategies, managing mood, and 
seeking social support 
 
Community Resources – listing and links to community supports 
 
Daily positive messages including some that focus on positive aspects of caregiving 
 
Managing behavior problems in care recipient –as part of the FITT-C, we developed a 
common behavior problem guide that includes recommended strategies to manage 
behaviors. We will use this guide to develop an interactive problem-solving approach.  
 
Stress management exercises – based on the mind-body intervention video/audio 
segments of breathing practices, guided meditation/relaxation exercises, simple yoga 
poses, and mindfulness themes 
 
Setting a task directive – based on caregiver assessments, certain tasks related to social 
support and family functioning will be recommended.  

 
Bibliotherapy – caregivers will be linked to important brochures and informational 
materials relevant to problem areas 
Table 1. Crosswalk between FITT-C Telephone Intervention, Mind-Body Intervention, and 
CARE-Well App 
FITT-C & Mind Body Key 
Areas 
CARE-Well Components 
Mood 
Daily positive messages;  
Health 
Health Tips; reminders to attend to their own nutrition, medical care, sleep, 
exercise; bibliotherapy 
Social Support 
Message forum; links to community resources; task directives to attend support 
groups and other activities 
Family Functioning 
Task directives to involve family in care; educational materials 
Care Recipient Behavior 
Problems 
Interactive problem-solving guide; message forum 
Yoga 
Audio/video (AV) segments – Neck and Shoulder rolls, Yoga Nidra (relaxation) 
Breathing 
AV segments: Prayer breath, alternate nostril breathing 
Meditation 
AV segments: Guided meditation 
Mindfulness 
Education about mindfulness exercises throughout the day, mindful eating, 
listening to music, walking meditation 
 
Phase 2. Beta Testing and Modification of the CARE-Well App. In this step (3 months), 
we will recruit 10 dementia caregivers to use the App for one month and then elicit feedback to 
modify and adapt the intervention. We will use purposive sampling to select diverse caregivers 
across sex, relationship type (spouse, adult child, other), race/ethnicity, and severity of 
dementia in care recipient. Otherwise, recruitment will be based on inclusion/exclusion criteria 
outlined in Aim 2. Participants will be recruited from multiple sources, including the Rhode Island 
Hospital (RIH) Alzheimer’s and Memory Disorders Center (two full-time neurologists seeing only 
aging and dementia cases; 728 new cases and 1,352 follow-ups annually), RIH 
Neuropsychology Program (6 full-time adult clinicians seeing about 50% older adult referrals; 
approximately 200 new dementia cases annually), and community advertising (including the 
Alzheimer’s Association, RI Chapter). Our research team has used these strategies previously 
to recruit almost 300 dementia caregivers for two intervention studies. Participants will be 
delivered a package that includes: one android tablet; two copies of the consent form and one 
prepaid postage envelope to return the signed consent form (if electronic consent form is for 
some reason inaccessible or unable to be completed for other reasons). A member of the study 
team will review the consent form (whether paper or electronic) with participants during a Zoom 
video call on the tablet. They will be instructed to sign and initial the form and send it back to the 
study team either via REDCap or in the prepaid postage envelope so that a member of the 
study team can sign it and send a signed copy back to them. Participants will be instructed to 
keep the unsigned copy in their records as a reference. Once a participant completes the 
consent process during the initial Zoom call, they will be given a de-identified Gmail username 
and password for the computer tablet/ App and will be shown how to operate the device and 
use the App. After one month of use, they will complete and participate in in-depth, semi-
structured interviews with two interviewers (clinical researcher and computer engineer). 
Interviewers will assure participants of privacy and emphasize confidentiality. Interviews will last 
approximately 30 minutes. Each interview will take place in a private location, will be digitally 
recorded with audio and video (via Zoom), and transcribed using NVivo software (QSR 
International, 2018). The interviews will follow a standard discussion guide, include probes to 
explore and seek clarification, and will address the participants’ experience with technical 
aspects of the App and content (see appendix for sample questions). We will also have 
quantitative data about frequency of App and component use. The PI along with Dr. Uebelacker 
will conduct the qualitative data analysis by identifying themes that can help with modifications 

of the user interface and content. We plan one month for modifications prior to beginning the 
feasibility study. 
Aim 2 Approach.  In this aim, we will conduct a feasibility trial, in which 40 dementia 
caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App 
or preloaded with internet links relevant to dementia and caregiving. Electronic outcome 
measures (detailed below) administered via REDCap secure web platform will be assessed at 
baseline and end of intervention (3 months) during each study visit. To measure sustainability of 
the App, the first 10 caregivers from each group will be offered the tablets for an additional 
month to monitor usage of the App outside the formal trial. The goal of this aim is to determine 
feasibility of the intervention, study procedures, and outcome measures. 
Participants & Recruitment. Informal caregivers of individuals (aged 18 and older) who 
are formally diagnosed with mild-moderate Alzheimer’s disease or related dementia (e.g., Lewy 
body dementia, frontotemporal dementia) documented by a neurologist, psychiatrist, or 
geriatrician will be screened for study eligibility (diagnoses will be confirmed via a release of 
information signed by the care recipient). Care recipients must be living in the community, not in 
nursing homes or assisted living facilities. Care recipients cannot have another serious, active 
medical illness besides dementia. Caregivers will be recruited from the RIH Alzheimer’s and 
Memory Disorders Center and RIH Neuropsychology Program by communication between the 
patients’ clinicians and their caregivers. In this way, we will obtain consent to contact the 
caregiver. In addition, we will provide letters to clinic patients that will invite their caregivers to 
participate in the study. Community advertising will also be implemented. We will recruit for 11 
months (Month 11-Month 21) and will need to recruit about 3-4 caregivers per month. In the 
past FITT-C trial, we had a recruitment rate of 4.7 caregivers per month. 
Inclusion/Exclusion Criteria. Inclusion criteria include: 1). adequate English-speaking and 
reading skills; 2). provide at least 4 hours of supervision per day for the care recipient (either 
directly or by telephone); 3). live in the community (either with the care recipient or without); 4). 
have provided supervision/assistance for at least six months prior to enrollment and have no 
plans for to place the care recipient in long term care or to end their role as caregiver within six 
months of study enrollment; 5). report some degree of distress associated with caregiving, 
which will be assessed through endorsement of two of nine negative experiences associated 
with caregiving (feeling overwhelmed or stressed, sad mood/depression, anger/frustration, loss 
of contact with family and friends, conflict in family or family stress, neglecting own health, 
demands or pressures from caregiving, exhaustion/fatigue, not taking care of their own needs or 
other responsibilities); and 6) access to WIFI at home. Exclusion criteria include: 1). major acute 
medical illness; 2). severe mental illness (e.g., bipolar, schizophrenia); or 3). diagnosed 
cognitive impairment. 
Procedure & Interventions. After screening and consenting, caregivers will complete an 
electronic baseline assessment (described below) and will be randomly assigned to receive a 
computer tablet that has the newly developed CARE-Well App or internet links relevant to 
dementia caregiving for 3 months. We will provide the caregivers with written information about 
expectations for the App use at orientation and they will be encouraged to use the website links 
daily. Computer engineers and/or a research assistant will provide IT support for caregivers in 
both groups. To minimize face-to-face contact during the COVID-19 pandemic, caregivers will 
remain at home to complete the second and final study ‘visit,’ which entails completing follow-up 
assessments within two weeks of intervention completion. Once follow-up assessments are 
complete, participants will be instructed to send the computer tablet back to RIH using a prepaid 
package given to them during their initial study visit. Due to time limitations of the current award, 
the first 10 caregivers in each group will be offered to keep the tablets and continue to use the 
App or internet links for an additional month to estimate intervention sustainability. 
Outcomes and Analyses. The primary goal of this project is to demonstrate feasibility of the 
CARE-Well App and study procedures to support a future trial. As such, the study is not 

powered to determine efficacy, but rather to determine 1) whether a future trial will be 
successfully conducted; and 2) whether an in-person caregiver intervention can be reasonably 
adapted into a mobile App. We will focus on the following (benchmarks in parentheses): 
 
Identify the best recruitment sites and methods (% who enrolled from each source and 
% contacts received from each recruitment method) 
 
Determine participant willingness to be randomized (% who decline participation 
because of randomization) 
 
Establish study enrollment rate and retention (latter variable examined by group) 
 
Determine adherence to intervention (% of participants who use the App or internet links 
at least once per day)  
 
Calculate timing of assessments and completion rates (% of assessments completed 
within two weeks of study enrollment and intervention completion)  
 
Determine interest in continuation of tablet/App use (along with frequency of use) after 
formal trial in a subset of caregivers (10 from each group) as an estimate of 
sustainability 
 
Collect ratings of satisfaction with technology and content (% satisfied or very satisfied) 
 
To establish feasibility for a future trial, we will collect standard dementia caregiving outcome 
measures at baseline and following the intervention via REDCap secure web platform. We have 
used these measures extensively in our previous work. These will include demographic 
characteristics (sex, age, education, race and ethnicity, characteristics of the caregiver (e.g., 
relationship to recipient, length of caregiving), and care recipient characteristics (e.g., dementia 
type and severity). We also will collect the following: 1). Depression: Center for Epidemiologic 
Studies Depression Scale, a 20-item self-report inventory (34); 2) Caregiver burden: Zarit 
Burden Interview, a 22-item self-report measure that examines subjective feelings related to the 
negative impact of caregiving on physical, emotional, financial, and social functioning (35). 3) 
Caregiver reaction to problem behaviors:  Revised Memory and Behavior Problem Checklist 
(36); 4). Desire to institutionalize: Desire to Institutionalize Scale (37): six-item scale to assess 
caregiver planning for long-term placement of the care recipient; 5). Healthcare resource 
utilization: Resource Utilization in Dementia - Lite Version (38); a measure on sexually 
disinhibited behaviors observed in the care recipient (39).  
Future Trial: Any challenges, recommendations from participants, and innovative solutions 
that emerge through the proposed project will assure the CARE-Well App will be well-developed 
and ready for testing in future trials. The next step will be a fully-powered efficacy study in a 
large sample of dementia caregivers. We will also examine the effect of CARE-Well on specific 
outcome measures (including behavioral change outcomes) as described above, examine 
moderators (mechanisms) of treatment (e.g., App usage, component analysis, caregiver 
characteristics), and compare the effect sizes of CARE-Well to the FITT-C telephone 
intervention. In the next stage of the intervention, we will examine sustainability of CARE-Well 
through monitoring usage and feedback from study participants. Given the widespread 
availability of mobile technology and internet access, we anticipate efficiently moving from 
efficacy to dissemination. We hope to disseminate the intervention on a community-level, where 
specific facilities or agencies can tailor the intervention as needed and post specific content in 
the message forums. Our future trial will combine Stage II (pure efficacy) and Stage III 
(community efficacy) components. In particular, we will examine the effect of study/setting 
(memory clinic, agency, community) on effectiveness and utilization of the App.   
 
Potential Problems and Alternative Strategies 
 

App development time. Although we plan on App development in 6 months, we may encounter 
issues that slow the process. If so, we will adjust the timeline and engage in early recruitment 
for both beta testing and the feasibility trial.  
Recruitment and attrition. Although our team has extensive experience recruiting dementia 
caregivers, we may encounter barriers to recruitment. If so, we will use community advertising 
or other methods. In addition, we will recruit an initial cohort while working on Aim 1, so we have 
a group ready to use the App as soon as the feasibility trial begins. 
App use. If we encounter low App or internet links use, we will increase reminders to 
participants. Older adults (who will likely comprise 50% of our sample) are increasingly using 
touchscreen devices (40) and accept and use tablet technology (41), suggesting that this would 
not be a confounding factor to the proposed App.  
 
Protection of Human Subjects 
 
All research contained in this proposal will be approved by the Rhode Island Hospital 
IRB before initiation. Written informed consent will be obtained for all participants. 
 
1. Risks to Human Subjects  
 
a. Human Subjects Involvement, Characteristics, and Design  
We will enroll a total of 50 caregivers of persons with dementia. Specific inclusion and 
exclusion criteria are detailed below. In Aim 1 of the study, 10 participants will 
participate in a one month use of the CARE-Well application, In Aim 2, 40 participants 
will be randomly assigned to receive 3 months of either the CARE-Well application or 
internet links in a feasibility study. They will be enrolled in the study for 3 months. This 
project will be a collaboration between Rhode Island Hospital and the University of 
Rhode Island (URI). Investigators at URI will engage in building the application and will 
participate in qualitative interviews as part of Aim1.  
 
Inclusion/Exclusion Criteria. Inclusion criteria include: 1). adequate English-speaking 
and reading skills; 2). provide at least one hour of supervision per day for the care 
recipient (either directly or by telephone); 3). live in the community (either with the care 
recipient or without); 4). have provided supervision/assistance for at least six months 
prior to enrollment and have no plans for to place the care recipient in long term care or 
to end their role as caregiver within six months of study enrollment; 5). report some 
degree of distress associated with caregiving, which will be assessed through 
endorsement of two of nine negative experiences associated with caregiving (e.g., 
feeling overwhelmed, sad mood, frustration, loss of family/friend contact, family conflict, 
etc.); and 6) access to wifi at home. Exclusion criteria include: 1). major acute medical 
illness; 2). severe mental illness (e.g., bipolar, schizophrenia; or 3). diagnosed cognitive 
impairment. 
 
b. Study Procedures, Materials, and Potential Risks  
Ten participants will be given an android tablet and asked to use a mobile application at 
least four times per week for one month. They will then participate in a qualitative 
interview in which they will be queried about technical and content aspects of the 
application. Participants in Aim 1 will be compensated $50.00 in the form of a check 

request at time of completion. As part of Aim 2, 40 participants will be complete baseline 
assessments and be randomly assigned to the CARE-Well application or internet 
educational links. They will be encouraged to use the application or links at least four 
times per week. Data will be collected via paper-pencil assessments from participants at 
two timepoints (Baseline and End-of-Treatment). The assessment measures will 
address mood, burden, reactions to behavior problems, health-related quality of life, 
sexual disinhibition in the care recipient, and desire to institutionalize the care recipient. 
The data from participants’ in-App weekly assessments of key areas will be 
programmed (using a computer algorithm) to generate personalized recommendations 
and references to relevant resources within the App. This data will not include any 
personal or health information and will not be extracted from the App. Participants in 
Aim 2 will be compensated $50 at study completion in the form of a check request. Any 
hard copies of data will be stored in locked file cabinets in a locked office. Electronic 
data storage will be in a password-protected database. 
 
There are no serious risks associated with participating in this study. Participants will 
undergo testing with standardized questionnaires and measures. They may feel slightly 
frustrated, fatigued, or bored when completing these tests. Because we will assess 
depression, there is a possibility that participants will report severe depression and/or 
suicidality. In addition, they are providing care for persons with dementia and we may 
uncover neglect or abuse. 
 
2. Adequacy of Protection Against Risks  
Confidentiality will be protected in the following ways: (1) participants’ names will not be 
included on the App, data sheets, or in the computerized database, (2) all data will be 
kept in a locked file cabinet in a locked office, and (3) the computer database will be 
password protected and only accessible by the researchers.  
 
a. Informed Consent and Assent  
We will follow standardized procedures for obtaining informed consent. 
Consent will be obtained at a face-to-face visit at the Neuropsychology Program 
office at Rhode Island Hospital. Consent will be obtained by one of the 
investigators or trained research staff. We will fully explain the study procedures, 
risks, benefits, and alternatives to all subjects. They will be informed that they 
can refuse to participate or withdraw from the study at any time, and that this will 
have no effect on any treatment or care they receive at our facility.  
 
 
b. . Protections Against Risk  
If potential participants report severe depressive symptoms or suicidality, 
we will refer them to the Acute Psychiatry Service at Rhode Island Hospital. The 
PI is a licensed clinical psychologist and has the skills to assess the suicidal risk 
and to make an appropriate referral. If there is evidence of elderly abuse or 
neglect, we will contact the Rhode Island Department of Elderly Affairs to report 
the concern. 
.  

 
c. Vulnerable Subjects, if relevant to your study  
Not relevant 
 
3. Potential Benefits of the Proposed Research to Research Participants and Others  
The potential benefit of developing a mobile health intervention to improve 
negative effects of dementia caregiving appears to outweigh the risks of the current 
study. Individuals in the beta test of the application may experience benefits from 
education and other strategies offered by the application. Caregivers in both groups of 
the feasibility study may benefit from educational materials and learn about dementia, 
caregiving strategies, and stress management. Those randomized to the mobile health 
application may benefit from techniques to manage the negative effects of caregiving 
and development of coping skills.  Participants will receive interventions free of charge.  
 
4. Importance of the Knowledge to be Gained  
Results of this study will help to develop an interactive, multicomponent mobile 
application for dementia caregivers. We will also collect data to inform a future 
large randomized trial to study the efficacy of the newly developed application. 
As such, the minimal risks to subjects in the current study seem reasonable 
given the knowledge to be gained.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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