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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44AG085945-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this pilot randomized controlled trial is to assess the impact of D2D rideshare services with a trained companion driver on the rate of medical appointments for older adults and individuals with AD/ADRD. Participants will be assigned either door-through-door (D2D) rideshare or curb-to-curb (C2C) rideshare services. he main question it aims to answer is:
Do D2D rideshare services reduce missed medical appointment rates compared to C2C rideshare services?
A pilot randomized controlled trial (Stage 1). By stratifying on levels of cognitive impairment, i.e., no cognitive impairment vs. have mild to moderate cognitive impairment/MCI or subjective cognitive decline/SCD, the research team will randomly assign 120 riders, who have scheduled medical appointments at partner practices of Onward, to one of two groups: Onward D2D service (intervention) vs. C2C rideshare (control).
Intervention Group (D2D): Door-to-Door rideshare services with a trained companion driver.
Control Group (C2C): Standard Curb-to-Curb rideshare services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group: Door-through-Door Rides | Experimental | Intervention Group (D2D): Door-to-Door rideshare services with a trained companion driver. |
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| Control Group (C2C): Curb-to-Curb Rides | Active Comparator | Control Group (C2C): Standard Curb-to-Curb rideshare services. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Door-through-door companion rideshare | Other | Door-through-Door Companion Drivers, unlike traditional rideshare services, are certified in CPR and first aid, and undergo onboard training to support older adults, individuals with mobility impairments, and those with AD/ADRD. They are trained to observe behaviors of AD/ADRD patients, monitor and detect risk of falls, elopement, and other events that may require extra assistance or emergency care during transport. Drivers accompany riders continuously until they can hand off riders to clinicians or other caregivers, or return them to their home. Technology features in the rideshare platform enable continuity of care, for consistent rider-driver matching and matching of riders to drivers based on support needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Appointment Adherence | The rate of missed medical appointments (No shows and same day cancellations). | 9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) | The impact of the intervention on participants' quality of life (QOL), as measured every 3 months during the study period using the ICECAP-A (ICEpop CAPability measure for Adults) Wellbeing and Quality of Life scale. ICECAP-A has the following five attributes, each of which can take one of four levels ranging from full capability to no capability, higher scores are better outcomes:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Wachter Petty, MBA | Contact | 800-700-4797 | kim.petty@onwardrides.com | |
| Brianna Matel, MSW | Contact | 800-700-4797 | brianna.matel@onwardrides.com |
| Name | Affiliation | Role |
|---|---|---|
| Kimberly Wachter Petty, MBA | Onward Health, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onward Health HQ | Recruiting | San Leandro | California | 94577 | United States |
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The Individual Participant Data (IPD) and supporting information will be made available starting 12 months after the completion of the study's primary endpoint analysis. Data will remain accessible for a period of 5 years following the final study report submission to ensure availability for secondary research and validation purposes.
Qualified researchers and institutions engaged in health disparities, transportation accessibility, and aging-related research will be able to access individual participant data (IPD) and supporting information. Access will be granted to de-identified data to ensure participant confidentiality.
Approved users will be able to access the following:
De-identified Individual Participant Data (IPD) Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Researchers will be required to submit a data access request, including a brief research proposal and data use agreement (DUA), outlining how the data will be used. Access will be provided through a secure data repository upon approval.
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| Curb-to-curb rideshare services | Other | Curb to curb rideshare services provided by a transportation network company (TNC) with drivers who don't have specialized training in supporting healthcare riders and who don't undergo fingerprint background checks or drug and alcohol testing. |
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| 9 months |
| Ride Acceptance Rates | Participant acceptance of the ride offered. | 9 Months |
| Ride Completion Rates | The completion rate of rides scheduled, as measured by the number of ride "No Shows" relative to rides booked. | 9 Months |
| Ride Satisfaction | Rider satisfaction with the rides received as rated on a 5 point star scale with 1 star being the lowest rating and 5 stars being the highest. | 9 Months |
| Transportation as a SDoH | Self reported unmet transportation needs as measured via surveys conducted every 3 months during the study period using Protocol for Responding to & Assessing Patients' Assets, Risks & Experiences (PRAPARE®) SDoH questionnaire transportation questions below. In the past 12 months, has lack of reliable transportation kept you from medical appointments, meetings, work or from getting things needed for daily living? Yes No Do you have trouble finding or paying for transportation? Yes No Has the inability to get your medications or get to appointments for care ever resulted in an emergency room visit or required hospitalization? Yes No | 9 Months |
| Caregiver Burnout | Participant caregiver ratings of caregiver burnout as measured by a survey conducted every 3 months during the study period using the HealthinAging.org Caregiver Self Assessment. Source: HealthinAging.org - https://www.healthinaging.org/tools-and-tips/caregiver-self-assessment-questionnaire The assessment asks 18 questions, 16 are Yes/No with scores over 10 "Yes" indicating burnout, and 2 on a 1-10 scale with scores over 6 indicating burnout. | 9 Months |
| Rider Loneliness and Social Isolation | Loneliness and Social Isolation will be measured every 3 months using the UCLA 3-Item Loneliness Scale.
Scoring: Sum the total of all items. Higher scores indicate greater degrees of loneliness. Possible range of scores from 3 to 9. Researchers in the past have grouped people who score 3 - 5 as "not lonely" and people with the score 6 - 9 as "lonely". | 9 Months |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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