The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 10, 2022
First Posted Date  ICMJE August 22, 2022
Last Update Posted Date August 22, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2022)
  • 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.
  • 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.
  • Prescribed medications [ Time Frame: 1 year ]
    Total number of prescribed medications, measured at intake, 6 months, and 1 year.
  • 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.
  • Weight [ Time Frame: 1 year ]
    Weight in pounds, measured at intake, 6 months, and 1 year.
  • BMI [ Time Frame: 1 year ]
    Body mass index, measured at intake, 6 months, and 1 year.
  • Blood Pressure [ Time Frame: 1 year ]
    Blood Pressure (mmHg), measured at intake, 6 months, and 1 year.
  • Hgb A1c [ Time Frame: 1 year ]
    Hemoglobin A1c, measured at intake, 6 months, and 1 year.
  • ADL [ Time Frame: 1 year ]
    Activities of daily living (Barthel index), measured at intake, 6 months, and 1 year.
  • IADL [ Time Frame: 1 year ]
    Instrumental activities of daily living (Lawton scale), measured at intake, 6 months, and 1 year.
  • Physical activity [ Time Frame: 1 year ]
    Physical activity / exercise assessment (Modified Kaiser physical activity survey), measured at intake, 6 months, and 1 year.
  • Psychosocial assessment [ Time Frame: 1 year ]
    Psychosocial assessment (PAT, Briggs Health), measured at intake, 6 months, and 1 year.
  • Cognitive function [ Time Frame: 1 year ]
    Cognitive function test (CPCOG), measured at intake, 6 months, and 1 year.
  • Depression screening [ Time Frame: 1 year ]
    Depression screening and/or assessment (MHA depression screening tool), measured at intake, 6 months, and 1 year.
  • 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.
  • 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.
  • Substance use [ Time Frame: 1 year ]
    Substance use or abuse (CAGE), measured at intake, 6 months, and 1 year.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Transportation Assets and the Effects on Wellness Metrics
Official Title  ICMJE ACTiN and Health Metrics: Improving Transportation Assets as a Critical Social Determinant of Health and the Effects on Wellness and Chronic Disease Metrics.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Social Determinants of Health
Intervention  ICMJE Behavioral: Transportation service
Improved transportation assets applied to all aspects of subjects life
Study Arms  ICMJE Experimental: Study arm
Low resource, high risk individuals with limited transportation options as a social determinant of health.
Intervention: Behavioral: Transportation service
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2022)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: John Salmon, MD 434-847-5050 john@unifiedpotential.org
Contact: Martha Brown 434-847-5050 marthabrown@lhchs.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05510765
Other Study ID Numbers  ICMJE 4212.081022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified data from all three datasets
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Available July 2024 (2 years)
Access Criteria: Government entity; Healthcare system
Current Responsible Party John M. Salmon IV, MD, Unified Potential, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE John M. Salmon IV, MD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Salmon, MD Medical Director, Lighthouse Community Health Center
PRS Account Unified Potential, Inc.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP