Alzheimer Disease or Associated DisorderPhase 1NCT06850870
Door-Through-Door Companion Rideshare Technology for Individuals With Alzheimer's Disease and Related Dementias (AD/ADRD)
A Phase 1 study testing Door-through-door companion rideshare and Curb-to-curb rideshare services in people with Alzheimer Disease or Associated Disorder and Dementia, run by Onward Health, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease or Associated Disorder, Dementia, Cognitive Decline
- What is being tested?
- Door-through-door companion rideshare and Curb-to-curb rideshare services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2025to 28 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants (or their surrogate) have the capacity to agree to allow Onward service for transportation;
- have scheduled medical appointments at partner practices of Onward;
- ages 60+
- community-dwelling;
- 60 participants who self-reported cognitive problems, such as memory issue, or have mild cognitive impairment, subjective cognitive decline, or AD/ADRD diagnosis
- Resides and attends appointments in the following San Francisco Bay Area Counties (San Francisco, Alameda, Contra Costa, Marin, San Mateo, Sonoma)
Who cannot join
- current enrollment in another transportation study;
- already using any type of free or heavily subsized transportation service;
- enrollees with comfort care only;
- Not wheelchair bound, e.g. if using a wheelchair must be foldable and must be able to transfer
- Transient, lacking consistent long term housing
- Resides outside of the San Francisco Bay Area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onward Door-Through-Door Companion Rideshare Technology to Improve Care for Older Adults and Individuals With Alzheimer's Disease and Related Dementias (AD/ADRD)
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?
Read the detailed description
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.
- Being tested
- Door-through-door companion rideshare, Curb-to-curb rideshare services
- Keywords
- Transportation
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Door-through-door companion rideshareOther
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.
Curb-to-curb rideshare servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Door-through-Door Rides | Experimental | Intervention Group (D2D): Door-to-Door rideshare services with a trained companion driver. Receives: Other: Door-through-door companion rideshare |
| Control Group (C2C): Curb-to-Curb Rides | Active comparator | Control Group (C2C): Standard Curb-to-Curb rideshare services. Receives: Other: Curb-to-curb rideshare services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appointment Adherence
The rate of missed medical appointments (No shows and same day cancellations).
Measured: 9 Months
Secondary outcomes (7)
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:
- Stability (being able to feel settled and secure)
- Attachment (being able to have love, friendship and support)
- Autonomy (being able to be independent)
- Achievement (being able to achieve and progress)
- Enjoyment (being able to have enjoyment and pleasure)
Measured: 9 months
Ride Acceptance Rates
Participant acceptance of the ride offered.
Measured: 9 Months
Ride Completion Rates
The completion rate of rides scheduled, as measured by the number of ride "No Shows" relative to rides booked.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 9 Months
Rider Loneliness and Social Isolation
Loneliness and Social Isolation will be measured every 3 months using the UCLA 3-Item Loneliness Scale.
- First, how often do you feel that you lack companionship: Hardly ever (1), some of the time (2), or often (3)?
- How often do you feel left out: Hardly ever (1), some of the time (2), or often (3)?
- How often do you feel isolated from others: Hardly ever (1), some of the time (2), or often (3)?
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".
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start29 Aug 2025
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease or Associated DisorderStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onward Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kimberly Wachter Petty, MBA, Principal investigator, Onward Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850870
- Sponsor's protocol ID
- OnwardRCT-2024-01 v2.0
- Other IDs
- 1R44AG085945-01A1
- Status last verified
- May 2026
- First submitted
- 17 Feb 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onward Door-Through-Door Companion Rideshare Technology to Improve Care for Older Adults and Individuals With Alzheimer's Disease and Related Dementias (AD/ADRD)
- ClinicalTrials.gov ID
- NCT06850870
- Acronym / sponsor ID
- OnwardRCT-2024-01 v2.0
- Keywords
- Transportation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Onward Health, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Door-through-Door Rides | Experimental | Other: Door-through-door companion rideshareIntervention Group (D2D): Door-to-Door rideshare services with a trained companion driver. |
| Control Group (C2C): Curb-to-Curb Rides | Active comparator | Other: Curb-to-curb rideshare servicesControl Group (C2C): Standard Curb-to-Curb rideshare services. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All participants (or their surrogate) have the capacity to agree to allow Onward service for transportation;
- have scheduled medical appointments at partner practices of Onward;
- ages 60+
- community-dwelling;
- 60 participants who self-reported cognitive problems, such as memory issue, or have mild cognitive impairment, subjective cognitive decline, or AD/ADRD diagnosis
Key exclusion criteria (6 listed)
- current enrollment in another transportation study;
- already using any type of free or heavily subsized transportation service;
- enrollees with comfort care only;
- Not wheelchair bound, e.g. if using a wheelchair must be foldable and must be able to transfer
- Transient, lacking consistent long term housing
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 |
|---|---|---|
| Door-through-door companion rideshareDoor-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. | Other | Intervention Group: Door-through-Door Rides |
| Curb-to-curb rideshare servicesCurb 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. | Other | Control Group (C2C): Curb-to-Curb Rides |
Primary outcome
Appointment Adherence
Time frame: 9 Months
The rate of missed medical appointments (No shows and same day cancellations).
7 secondary outcomes
Quality of Life (QOL)
Time frame: 9 months
Ride Acceptance Rates
Time frame: 9 Months
Ride Completion Rates
Time frame: 9 Months
Ride Satisfaction
Time frame: 9 Months
Transportation as a SDoH
Time frame: 9 Months
Caregiver Burnout
Time frame: 9 Months
Rider Loneliness and Social Isolation
Time frame: 9 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Kimberly Wachter Petty, MBA principal investigator
Onward Health, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Door-through-door companion rideshare and Curb-to-curb rideshare services in people with Alzheimer Disease or Associated Disorder and Dementia, run by Onward Health, Inc 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Appointment Adherence (time frame: 9 Months). 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 21 Jul 2026.