- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437651
WayFinder Ride Phase I Study
WayFinder Ride Phase I Study Device Usability Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The WayFinder Ride prototype system will be evaluated to determine usability, accessibility, and proof of concept. Sixty-six people with IDD will participate in this Phase I study. Our sample size estimates are based on testing the differences of the mean total number of errors that occur among groups on the WayFinder Ride, Uber, and Lyft applications. A total of 66 participants, 22 in each group, will be enrolled in this randomized three-arm study to account for a possible 20% attrition rate. The study will have 80% power to detect a moderate to large effect size of f=0.41(characterized by a ratio of the standard deviation of the group means over the common standard deviation) using a one-way analysis of covariance (ANCOVA) at a two-sided 0.05 significance level, assuming the adjusted covariates has an R-squared of 0.2. Participants will be aged 18 or older and have a documented IDD. Demographics will be collected including full scale IQ scores and the Adaptive Behavior Assessment System - 3rd edition (ABAS-3)22 scores for each participant to confirm that they meet the diagnostic criteria of having deficits in the conceptual, practical, and social areas of adaptive functioning. This will allow researchers to track the levels of adaptive functioning of the participants to understand the potential impact on usability and accuracy. The investigators will use a combined IQ and ABAS-3 score as a covariate in the analysis. Temple University will recruit participants through their extensive networks of relationships with community-based organizations that support individuals with IDD (see letters of support). Leaders at the organizations will provide study information to participants that meet the inclusion criteria. Those expressing interest will be connected with the project team to confirm they meet the inclusion criteria and answer questions about the study. Participants will be scheduled for an in-person meeting at a convenient, accessible location if appropriate at the time of data collection.
After obtaining informed consent and/or assent, participants with IDD will be randomly assigned to one of three groups: 1) WayFinder Ride prototype, 2) Uber application, or 3) Lyft application. Each participant will be assigned a study ID in order of entry. This list of IDs 1-66 will have been pre-randomized prior to starting recruitment, so that an equal number of participants end up in each group. Participants will complete a simulation of scheduling a trip on their assigned rideshare application. Research team members will observe participants completing the test session and track the number of errors and the amount of support needed per protocol. No actual ride requests will be placed during the test sessions. Participants will use a cognitively accessible ATLAS survey that will be developed for this project and will receive support as needed to complete the rating scales to increase the validity of responses. Rating scales will be in plain language and have visual and auditory supports to increase usability. Participants will complete short interviews about the usability of the app with the researchers after completing the testing and rating forms. During qualitative interviews, researchers will use the answers on the rating scales to ask targeted questions about low and high ratings with the purpose of obtaining more detailed qualitative information on aspects of the interface impacting usability and accessibility. Participants with IDD will receive a $30 gift card for participation in the study. The WayFinder Ride prototype system will be evaluated to determine usability, accessibility, and proof of concept. Sixty-six people with IDD will participate in this Phase I study. Our sample size estimates are based on testing the differences of the mean total number of errors that occur among groups on the WayFinder Ride, Uber, and Lyft applications. A total of 66 participants, 22 in each group, will be enrolled in this randomized three-arm study to account for a possible 20% attrition rate. The study will have 80% power to detect a moderate to large effect size of f=0.41 (characterized by a ratio of the standard deviation of the group means over the common standard deviation) using a one-way analysis of covariance (ANCOVA) at a two-sided 0.05 significance level, assuming the adjusted covariates has an R-squared of 0.2. Participants will be aged 18 or older and have a documented IDD. Demographics will be collected including full scale IQ scores and the Adaptive Behavior Assessment System - 3rd edition (ABAS-3)22 scores for each participant to confirm that they meet the diagnostic criteria of having deficits in the conceptual, practical, and social areas of adaptive functioning. This will allow researchers to track the levels of adaptive functioning of the participants to understand the potential impact on usability and accuracy. The investigators will use a combined IQ and ABAS-3 score as a covariate in the analysis. Additionally, 20 parent/caregiver and service providers who have consistent weekly contact with an individual with IDD who is at least 18 years of age will be recruited to provide feedback on the usability and accessibility of the prototype through a rating scale and qualitative interviews. Temple University will recruit participants through their extensive networks of relationships with community-based organizations that support individuals with IDD (see letters of support). Leaders at the organizations will provide study information to participants that meet the inclusion criteria. Those expressing interest will be connected with the project team to confirm they meet the inclusion criteria and answer questions about the study. Participants will be scheduled for an in-person meeting at a convenient, accessible location if appropriate at the time of data collection. After obtaining informed consent and/or assent, participants with IDD will be randomly assigned to one of three groups: 1) WayFinder Ride prototype, 2) Uber application, or 3) Lyft application. Each participant will be assigned a study ID in order of entry. This list of IDs 1-66 will have been pre-randomized prior to starting recruitment, so that an equal number of participants end up in each group. Participants will complete a simulation of scheduling a trip on their assigned rideshare application. Research team members will observe participants completing the test session and track the number of errors and the amount of support needed per protocol. No actual ride requests will be placed during the test sessions. Parents/caregiver participants (n=20) will complete a simulated trip request on the WayFinder Ride prototype and then provide feedback through a rating scale and qualitative interviews. All participants will complete the rating scale on the usability and accessibility of their assigned application immediately after the session. Participants will use a cognitively accessible ATLAS survey14,15 that will be developed for this project and will receive support as needed to complete the rating scales to increase the validity of responses. Rating scales will be in plain language and have visual and auditory supports to increase usability. Participants will complete short interviews about the usability of the app with the researchers after completing the testing and rating forms. During qualitative interviews, researchers will use the answers on the rating scales to ask targeted questions about low and high ratings with the purpose of obtaining more detailed qualitative information on aspects of the interface impacting usability and accessibility. Participants with IDD will receive a $30 gift card for participation in the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- REACH Collective, Temple University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- documented intellectual and developmental disability
- age 18 and older
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitively accessible ride request prototype
Use of WayFinder Ride prototype
|
Cognitively accessible ride share prototype app
|
|
Experimental: Mainstream Lyft rideshare app
Use of Lyft app
|
Use of the Lyft Mainstream App for requesting a ride
|
|
Experimental: Mainstream Uber rideshare app
Use of Uber app
|
Use of the Uber Mainstream App for requesting a ride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rideshare request error percentage
Time Frame: From enrollment to the end of treatment at 2 weeks
|
Device usability as measured by measured by the ability for individuals to use the selected app to request a rideshare ride for a specific destination and specific point of origin.
The ability to use the device independently will be measured by evaluating the percent of errors made while attempting to arrange a rideshare ride.
|
From enrollment to the end of treatment at 2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R44HD113503-01A1-Phase1
- 472488 (Other Identifier: NIH)
- 1R44HD113503-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on WayFinder Ride Prototype
-
Mahidol UniversityNot yet recruitingEvaluate the Prototype Digital Vaccine Platform
-
Centre Hospitalier Universitaire, AmiensActive, not recruitingProblem Behavior | Dementia | Elderly | Adapted Garment Prototype | Sphincter DisordersFrance
-
Methodist Health SystemTerminatedAlcohol Drinking | Drug Use | Alcohol Intoxication | Sexual Assault | Ride Sharing | Motor CollisionUnited States
Clinical Trials on WayFinder Ride Phase I Prototype
-
Virginia Commonwealth UniversityOrganization for Autism ResearchCompletedAutismUnited States
-
Genentech, Inc.CompletedHealthy VolunteerUnited Kingdom
-
Bharat Biotech International LimitedIndian Council of Medical ResearchCompletedCOVID-19 | SARS-CoV-2 InfectionIndia
-
Genentech, Inc.RecruitingSolid TumorIsrael, Spain, United States, France, Singapore, Australia, Canada, United Kingdom, South Korea
-
KK Women's and Children's HospitalNational University Hospital, Singapore; Singapore General HospitalRecruitingLymphoblastic Leukemia, Acute, Childhood | Lymphoblastic Leukemia | Lymphoblastic Leukemia, Acute Adult | Lymphoblastic Leukemia in Children | CARSingapore
-
European Institute of OncologyRecruiting
-
Centre Georges Francois LeclercRecruiting
-
Scripps Clinic Cancer CenterThreshold PharmaceuticalsUnknownHepatocellular CarcinomaUnited States
-
Riphah International UniversityRecruitingCoronary Artery StenosisPakistan