NCT05510765

Brief Summary

  1. 1.Implementation of an Advanced Connected Transportation Network (ACTiN), a novel, collaborative multinetwork transportation model for small cities and rural areas.
  2. 2.Evaluation of effectiveness in improving transportation assets for clients of a community-based nonprofit specializing in addressing social determinants of health (Lighthouse Community Health Services in Lynchburg, VA).
  3. 3.Simultaneous evaluation of wellness metrics based on the standards of the CMS Annual Wellness Visit and metrics associated with common chronic diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 10, 2022

Last Update Submit

August 19, 2022

Conditions

Social Determinants of Health

Outcome Measures

Primary Outcomes (4)

  • Rides completed

    Total number of rides for test subject per week, averaged over previous 6 months, measured at intake, 6 months, and 1 year.

    1 year

  • Cost of transportation

    Total cost per mile of transportation, averaged over previous 6 months, measured at intake, 6 months, and 1 year.

    1 year

  • Untreated disease(s)

    Total number of attributed disease diagnoses that are not being treated, measured at intake, 6 months, and 1 year.

    1 year

  • Cancer screening success

    Number of eligible cancer screening exams not performed (lung, colon, breast), measured at intake, 6 months, and 1 year.

    1 year

Secondary Outcomes (17)

  • Unmet transportation needs

    1 year

  • Unmet medical transportation needs

    1 year

  • Prescribed medications

    1 year

  • Prescribed medications not utilized

    1 year

  • Weight

    1 year

  • +12 more secondary outcomes

Study Arms (1)

Study arm

EXPERIMENTAL

Low resource, high risk individuals with limited transportation options as a social determinant of health.

Behavioral: Transportation service

Interventions

Transportation serviceBEHAVIORAL

Improved transportation assets applied to all aspects of subjects life

Study arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult resident of the City of Lynchburg, Virginia
  • Under-resourced at trial entry as defined by meeting eligibility for welfare, food stamps/SNAP, Medicaid, Housing Choice Voucher program, or income at or below 200% of the Federal Poverty Threshold.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighthouse Community Health Center

Lynchburg, Virginia, 24504, United States

Location

Related Publications (3)

  • Bradley EH, Elkins BR, Herrin J, Elbel B. Health and social services expenditures: associations with health outcomes. BMJ Qual Saf. 2011 Oct;20(10):826-31. doi: 10.1136/bmjqs.2010.048363. Epub 2011 Mar 29.

    PMID: 21447501BACKGROUND

  • Solberg LI. Theory vs Practice: Should Primary Care Practice Take on Social Determinants of Health Now? No. Ann Fam Med. 2016 Mar;14(2):102-3. doi: 10.1370/afm.1918. No abstract available.

    PMID: 26951583BACKGROUND

  • Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health Rankings: Relationships Between Determinant Factors and Health Outcomes. Am J Prev Med. 2016 Feb;50(2):129-35. doi: 10.1016/j.amepre.2015.08.024. Epub 2015 Oct 31.

    PMID: 26526164BACKGROUND

MeSH Terms

Interventions

Transportation

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

  • John Salmon, MD

    Medical Director, Lighthouse Community Health Center

    STUDY DIRECTOR

Central Study Contacts

John Salmon, MD

CONTACT

434-847-5050john@unifiedpotential.org

Martha Brown

CONTACT

434-847-5050marthabrown@lhchs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director, Lighthouse Community Health Center

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 22, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Deidentified data from all three datasets

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Available July 2024 (2 years)
Access Criteria
Government entity; Healthcare system

Locations

US(1)