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| ID | Type | Description | Link |
|---|---|---|---|
| R00AG073509 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to develop and test CarePair, a mobile application-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being.
The main aims of this study are:
Caregiver participants will be asked to log in and use the CarePair application and complete study activities for a six-week duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up.
In 2024, approximately 6.9 million diagnosed cases of Alzheimer's disease and related dementias (ADRD) were reported in the United States, with 83% of the caregiving burden shouldered by unpaid family members or friends. The duration of ADRD varies between 4-20 years, during which individuals often transition into a state of complete dependency. Without family caregivers, the long-term services and support system would be unsustainable. The dearth of accessible support for ADRD caregivers constitutes a significant public health emergency. Caregivers are frequently uncertain of which services are needed, available, and how to gain access - often leaving those most vulnerable without essential support. When queried about service underuse, study respondents who participated in the K99 phase of this project highlighted an information deficit tailored to specific cultures, demographics, and dementia types. They described the excess of online information as overwhelming, often irrelevant, impractical, or unaffordable. Existing technology-based solutions targeted toward enhancing personalized caregiver support are limited. Leveraging continued innovations in technology to inform the training and testing of machine learning algorithms, which can match and update resources while accounting for individual needs, preferences (in-person, virtual), and barriers (e.g., employment, lack of respite care), holds great potential to enhance the precision of service linkage for ADRD caregivers. This R00 project aims to develop, refine, and pilot test CarePair (formerly the Caregiver Resource Room), a mobile application assessment and service referral platform for dementia caregivers. CarePair will leverage innovative machine learning algorithms to holistically evaluate caregivers' evolving needs, their barriers, and preferences to generate personalized service referrals relevant to their areas of identified need. Thus, the specific aims of the R00 are to 1) Use mixed-method and focus group data from the K99 phase to inform the iterative development of the CarePair, which includes a digital self-assessment tool employing machine learning to identify needs, categorize them, and generate targeted service recommendations; 2) Evaluate front- and back-end usability (e.g., via task analysis, heuristic evaluation) of the tool's content, design, features, functionality, and accuracy of service output. Feedback will inform modifications and iterative refinement of the CarePair Version 2.0; 3) Conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of CarePair in enhancing service awareness, addressing unmet needs, and improving mental health. The proposed research aligns with the NIA's strategic initiative to foster research scientists in aging and to develop promising interventions to better engage and support the well-being of ADRD family caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Participants randomized to the control arm will receive access to an attention-matched comparator: a digital folder containing the same caregiving articles available in the CarePair app. However, the materials will not be personalized or organized. Participants will be asked to log into the digital folder twice per week and read one article at each login, for a total of 12 logins and articles over the 6-week study period, mirroring the engagement frequency of the intervention group. | |
| CarePair Intervention Arm | Experimental | Participants randomized to the intervention arm will receive access to the CarePair app, a needs-based digital platform that delivers tailored recommendations for Alzheimer's disease and related dementias (ADRD) resources designed for family caregivers. These include services and educational articles personalized based on the caregiver's self-reported needs and preferences, with content organized by relevance to each user. Participants will be asked to log into the CarePair app twice per week and engage with one article per login, for a total of 12 logins and articles over the 6-week study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CarePair | Behavioral | This study will pilot test the feasibility and acceptability of a digital self-assessment and referral tool using machine learning models to enhance service use and address unmet needs in ADRD caregivers. |
| Measure | Description | Time Frame |
|---|---|---|
| The Feasibility of the CarePair study as measured by the proportion of family caregivers who complete the study screening survey. | The feasibility of the CarePair study will be measured by the proportion of family caregivers who complete the study screening survey among those who were directly invited to participate the study. | Enrollment |
| The Feasibility of the CarePair study as measured by the proportion of family caregivers who consent to participate and are enrolled. | The feasibility of the CarePair study will be measured by the proportion of family caregivers who consent to participate among those who were screened into the study. Participants who consent to participate are then immediately randomized to their assigned condition and thus enrolled. | Enrollment |
| The Feasibility of the CarePair study as measured by the proportion of are deemed eligible based on screening criteria. | The feasibility of the CarePair study will be measured by the proportion of family caregivers who are deemed eligible to participate based on screening criteria among those who completed the study's screening survey. | Enrollment |
| The Feasibility of the CarePair study as measured by recruitment rates and the proportion of family caregivers that decline participation. | The feasibility of the CarePair study will be measured by the proportion of eligible family caregivers who decline to participate among those who were screened into the study. | Enrollment |
| The Feasibility of the CarePair study as measured by participant retention, as indicated by the number of participants lost to follow-up. | Participant retention, as an aspect of feasibility, will be measured by the recorded number of participants number lost to follow-up. A number of the enrolled participants who the study team contacted weekly for 4 weeks, but did not answer or continue participation, will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Caregiver Needs scores on a 12-item Needs Assessment | A 12-item caregiver needs assessment will be used to measure family caregivers' care-related needs, such as legal guidance, social support, and education. Total scores range from 12-48, with higher scores representing greater caregiver needs. | Baseline; 6-Week Follow-Up |
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Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca B Falzarano, PhD | Contact | 6464812858 | falzaran@usc.edu | |
| Annabelle V Greenfield, BS | Contact | 6467809506 | ag69282@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Francesca Falzarano, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Recruiting | Los Angeles | California | 90089 | United States |
Data collected for the CarePair study will only be shared after the investigators have published the data addressing the study's specific aims. Intellectual property and data generated under this project will be administered in accordance with both University of Southern California (USC) and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance. After publication of the investigator's main findings, access to databases and associated software tools generated and the code to create these tools under the project will be available for educational, research and non-profit purposes.
These data will be shared after the investigators have published the specific aims of this study. Requests for the code used to create CarePair will be reviewed by the investigative team and shared once feasibility, acceptability, and preliminary efficacy has been examined and the findings have been published.
Individuals who wish to access the data are required to: 1) Use the data for research purposes only; 2) Not identify any individual participant; 3) Secure the data using appropriate computer technology such as password-protected servers and files; and 4) Return and/or destroy data after analyses are complete.
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| Enrollment to 6-Week Follow-Up |
| The Feasibility of the CarePair study as measured by participant retention, as indicated by the number of recorded dropouts. | Participant retention, as an indicator of feasibility, will be assessed by recording the number of participants who withdraw from the study after enrollment | Enrollment to 6-Week Follow-Up |
| The Feasibility of the CarePair application as measured by the number of app logins per participant out of total required (minimum= 12). | The feasibility of the application will be measured by the number of times the participant logs in to the CarePair application. The minimum number of logins recommended to the participants is 12 (2x/week for 6 weeks). | Baseline to 6-Week Follow-Up |
| The Feasibility of the CarePair application as measured by the number of app interactions per participant out of total required (minimum= 12). | Feasibility of the application will be assessed based on the number of participant interactions with CarePair's features, such as reviewing, rating, taking notes on, or saving services or articles. Participants are asked to log in and engage with the app approximately twice per week over the six-week study period, for a recommended minimum of 12 total interactions. | Baseline to 6-Week Follow-Up |
| Application Usability, as measured using the validated System Usability Scale (SUS). | Usability and accessibility of the CarePair application design will be measured using the validated System Usability Scale (SUS). Total scores for the SUS range from 0-100, with higher scores indicative of greater usability. A threshold score of 68 is used to indicate adequate usability. | 6-Week Follow-Up |
| Application usability, as measured using the validated User Version of the Mobile App Rating Scale (uMARS). | Usability of the CarePair application will be measured using the validated user version of the Mobile App Rating Scale (uMARS). The uMARS provides a multidimensional assessment of app quality, including engagement, functionality, aesthetics, and information. Scores range from 20 to 100, with higher scores indicating more favorable user evaluations of the app's usability and overall quality. | 6-Week Follow-Up |
| The Acceptability of the CarePair application as measured by a survey that measures the participants satisfaction and acceptability of the application. | The acceptability of the CarePair application will be measured by the use of surveys assessing usability, engagement, acceptability, suggestions for improvement. Participants will be asked to rate their agreement with statements including "I enjoyed my experience using the CarePair application". Response options are rated on a five-point scale from 1-Strongly Disagree to 5-Strongly Agree. Scores range from 9-45, with higher scores indicating greater satisfaction and acceptability. | 6-Week Follow-Up |
| The Acceptability of the CarePair application as measured by a qualitative survey that measures the participants satisfaction and acceptability of the application. | The acceptability of the CarePair application will be measured by the use of open-ended items assessing usability, engagement, acceptability, suggestions for improvement. The intervention group participants will be administered five open-ended qualitative items asking for feedback on CarePair. Sample items include: "Would you continue using the CarePair application after this study? Why or why not?" | 6-Week Follow-Up |
| Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy | Caregiving Self-Efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy. Total scores range from 0-100, with higher scores indicative of greater feelings of perceived self-efficacy. | Baseline; 6-Week Follow-Up |
| Change from Baseline Caregiver Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9). | The PHQ-9 will be used to measure family caregiver depressive symptoms. Total scores range from 0-27, with higher scores indicative of greater caregiver depressive symptoms. | Baseline; 6-Week Follow-Up |
| Change from Baseline Anxiety scores on the Generalized Anxiety Disorder-7 (GAD-7) | Change in caregivers' anxiety scores will be assessed using the GAD-7. Scores range from 0-21, with higher scores indicating a greater level of anxiety. | Baseline; 6-Week Follow-Up |
| Change from Baseline Caregiver Stress as measured by the Kingston Caregiver Stress Scale (KCSS) | The KCSS will be used to measure family caregiver stress. Total scores range from 20-50, with higher scores indicative of greater caregiver stress. | Baseline; 6-Week Follow-Up |
| Change from Baseline Quality of Life scores on the 5-item Satisfaction with Life Scale (SWLS) | The SWLS will be used to measure family caregiver quality of life. Total scores range from 5-35, with a score of 20 representing a neutral point on the scale. Higher scores indicate a greater level of satisfaction with life. | Baseline; 6-Week Follow-Up |
| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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