NCT06850870

Brief 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. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Aug 2025Nov 2026

First Submitted

Initial submission to the registry

February 17, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 29, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2026

Last Updated

November 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

February 17, 2025

Last Update Submit

November 22, 2025

Conditions

Keywords

Transportation

Outcome Measures

Primary Outcomes (1)

  • Appointment Adherence

    The rate of missed medical appointments (No shows and same day cancellations).

    9 Months

Secondary Outcomes (7)

  • Quality of Life (QOL)

    9 months

  • Ride Acceptance Rates

    9 Months

  • Ride Completion Rates

    9 Months

  • Ride Satisfaction

    9 Months

  • Transportation as a SDoH

    9 Months

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group: Door-through-Door Rides

EXPERIMENTAL

Intervention Group (D2D): Door-to-Door rideshare services with a trained companion driver.

Other: Door-through-door companion rideshare

Control Group (C2C): Curb-to-Curb Rides

ACTIVE COMPARATOR

Control Group (C2C): Standard Curb-to-Curb rideshare services.

Other: Curb-to-curb rideshare services

Interventions

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.

Intervention Group: Door-through-Door Rides

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.

Control Group (C2C): Curb-to-Curb Rides

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onward Health HQ

San Leandro, California, 94577, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Kimberly Wachter Petty, MBA

    Onward Health, Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Wachter Petty, MBA

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 27, 2025

Study Start

August 29, 2025

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

November 28, 2026

Last Updated

November 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
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.
Access Criteria
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.

Locations