ACTiN: Improving Transportation Assets and the Effects on Wellness Metrics

Sponsor
John M. Salmon IV, MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05510765
Collaborator
(none)
50
1
1
15
3.3

Study Details

Study Description

Brief Summary

  1. Implementation of an Advanced Connected Transportation Network (ACTiN), a novel, collaborative multinetwork transportation model for small cities and rural areas.

  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. Simultaneous evaluation of wellness metrics based on the standards of the CMS Annual Wellness Visit and metrics associated with common chronic diseases.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Transportation service
N/A

Detailed Description

  1. Implementation of a community transportation solution The project will be managed by Unified Potential, Inc., a 501c3 tax-exempt organization for transportation.
  • The solution requires implementation of four separate transportation "networks"

  • Public / Contracted / For-Hire Transportation

  • Workforce Transportation Network

  • Community Rideshare Network

  • Volunteer Transportation Network

  1. Assessment of Personal Transportation Assets
  • Subjects asked to complete a survey upon intake, at six months, and at one year

  • Digital survey:

  • Can be completed by individual using provided smartphone app or at onsite desktop kiosk

  • Can be facilitated by a caregiver or other provider not involved in data analysis

  1. Assessment of health and wellness metrics and chronic disease metrics if applicable
  • Dataset based on metrics assessed in the Center for Medicare and Medicaid Services (CMS) Annual Wellness Visit

  • All metrics quantified via either binary (yes/no) or through use of a validated scale (see below)

  • Data collected electronically at onsite or in-home provider visits at intake, six months, and one year

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
ProspectiveProspective
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
ACTiN and Health Metrics: Improving Transportation Assets as a Critical Social Determinant of Health and the Effects on Wellness and Chronic Disease Metrics.
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study arm

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

Behavioral: Transportation service
Improved transportation assets applied to all aspects of subjects life

Outcome Measures

Primary Outcome Measures

  1. Rides completed [1 year]

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

  2. Cost of transportation [1 year]

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

  3. Untreated disease(s) [1 year]

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

  4. Cancer screening success [1 year]

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

Secondary Outcome Measures

  1. Unmet transportation needs [1 year]

    Total number of rides per week that test subject is unable to complete, averaged over 6 previous 6 months, measured at intake, 6 months, and 1 year.

  2. Unmet medical transportation needs [1 year]

    Total number of medical (including mental health) appointments missed due to transportation, averaged over previous 6 months, measured at intake, 6 months, and 1 year.

  3. Prescribed medications [1 year]

    Total number of prescribed medications, measured at intake, 6 months, and 1 year.

  4. Prescribed medications not utilized [1 year]

    Total number of prescribed medications that are not being utilized (all cause), averaged over previous 6 months, measured at intake, 6 months, and 1 year.

  5. Weight [1 year]

    Weight in pounds, measured at intake, 6 months, and 1 year.

  6. BMI [1 year]

    Body mass index, measured at intake, 6 months, and 1 year.

  7. Blood Pressure [1 year]

    Blood Pressure (mmHg), measured at intake, 6 months, and 1 year.

  8. Hgb A1c [1 year]

    Hemoglobin A1c, measured at intake, 6 months, and 1 year.

  9. ADL [1 year]

    Activities of daily living (Barthel index), measured at intake, 6 months, and 1 year.

  10. IADL [1 year]

    Instrumental activities of daily living (Lawton scale), measured at intake, 6 months, and 1 year.

  11. Physical activity [1 year]

    Physical activity / exercise assessment (Modified Kaiser physical activity survey), measured at intake, 6 months, and 1 year.

  12. Psychosocial assessment [1 year]

    Psychosocial assessment (PAT, Briggs Health), measured at intake, 6 months, and 1 year.

  13. Cognitive function [1 year]

    Cognitive function test (CPCOG), measured at intake, 6 months, and 1 year.

  14. Depression screening [1 year]

    Depression screening and/or assessment (MHA depression screening tool), measured at intake, 6 months, and 1 year.

  15. Other mental health conditions [1 year]

    Other mental health conditions (MHA screening and assessment tools), measured at intake, 6 months, and 1 year.

  16. Smoking assessment [1 year]

    Smoking / tobacco / nicotine use (No/Yes, with yes triggering LDCT assessment), measured at intake, 6 months, and 1 year.

  17. Substance use [1 year]

    Substance use or abuse (CAGE), measured at intake, 6 months, and 1 year.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lighthouse Community Health Center Lynchburg Virginia United States 24504

Sponsors and Collaborators

  • John M. Salmon IV, MD

Investigators

  • Study Director: John Salmon, MD, Medical Director, Lighthouse Community Health Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
John M. Salmon IV, MD, Medical Director, Lighthouse Community Health Center, Unified Potential, Inc.
ClinicalTrials.gov Identifier:
NCT05510765
Other Study ID Numbers:
  • 4212.081022
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 22, 2022