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Improving Transportation Assets and the Effects on Wellness Metrics (ACTiN)

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ClinicalTrials.gov Identifier: NCT05510765
Recruitment Status : Not yet recruiting
First Posted : August 22, 2022
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
John M. Salmon IV, MD, Unified Potential, Inc.

Study Description
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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
Social Determinants of Health Behavioral: Transportation service Not Applicable

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

  2. 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

  3. 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective
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.
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Rides completed [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    Total number of prescribed medications, measured at intake, 6 months, and 1 year.

  4. Prescribed medications not utilized [ Time Frame: 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 [ Time Frame: 1 year ]
    Weight in pounds, measured at intake, 6 months, and 1 year.

  6. BMI [ Time Frame: 1 year ]
    Body mass index, measured at intake, 6 months, and 1 year.

  7. Blood Pressure [ Time Frame: 1 year ]
    Blood Pressure (mmHg), measured at intake, 6 months, and 1 year.

  8. Hgb A1c [ Time Frame: 1 year ]
    Hemoglobin A1c, measured at intake, 6 months, and 1 year.

  9. ADL [ Time Frame: 1 year ]
    Activities of daily living (Barthel index), measured at intake, 6 months, and 1 year.

  10. IADL [ Time Frame: 1 year ]
    Instrumental activities of daily living (Lawton scale), measured at intake, 6 months, and 1 year.

  11. Physical activity [ Time Frame: 1 year ]
    Physical activity / exercise assessment (Modified Kaiser physical activity survey), measured at intake, 6 months, and 1 year.

  12. Psychosocial assessment [ Time Frame: 1 year ]
    Psychosocial assessment (PAT, Briggs Health), measured at intake, 6 months, and 1 year.

  13. Cognitive function [ Time Frame: 1 year ]
    Cognitive function test (CPCOG), measured at intake, 6 months, and 1 year.

  14. Depression screening [ Time Frame: 1 year ]
    Depression screening and/or assessment (MHA depression screening tool), measured at intake, 6 months, and 1 year.

  15. Other mental health conditions [ Time Frame: 1 year ]
    Other mental health conditions (MHA screening and assessment tools), measured at intake, 6 months, and 1 year.

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

  17. Substance use [ Time Frame: 1 year ]
    Substance use or abuse (CAGE), measured at intake, 6 months, and 1 year.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05510765


Contacts
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Contact: John Salmon, MD 434-847-5050 john@unifiedpotential.org
Contact: Martha Brown 434-847-5050 marthabrown@lhchs.com

Locations
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United States, Virginia
Lighthouse Community Health Center
Lynchburg, Virginia, United States, 24504
Sponsors and Collaborators
John M. Salmon IV, MD
Investigators
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Study Director: John Salmon, MD Medical Director, Lighthouse Community Health Center
More Information
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Publications:

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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: August 22, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data from all three datasets
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Available July 2024 (2 years)
Access Criteria: Government entity; Healthcare system

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No