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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05510765
Other study ID # 4212.081022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date January 2024

Study information

Verified date August 2022
Source Unified Potential, Inc.
Contact John Salmon, MD
Phone 434-847-5050
Email john@unifiedpotential.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date January 2024
Est. primary completion date October 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Lighthouse Community Health Center Lynchburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
John M. Salmon IV, MD

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Cost of transportation Total cost per mile of transportation, averaged over previous 6 months, measured at intake, 6 months, and 1 year. 1 year
Primary Untreated disease(s) Total number of attributed disease diagnoses that are not being treated, measured at intake, 6 months, and 1 year. 1 year
Primary 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 Unmet transportation needs 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. 1 year
Secondary Unmet medical transportation needs 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. 1 year
Secondary Prescribed medications Total number of prescribed medications, measured at intake, 6 months, and 1 year. 1 year
Secondary Prescribed medications not utilized 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. 1 year
Secondary Weight Weight in pounds, measured at intake, 6 months, and 1 year. 1 year
Secondary BMI Body mass index, measured at intake, 6 months, and 1 year. 1 year
Secondary Blood Pressure Blood Pressure (mmHg), measured at intake, 6 months, and 1 year. 1 year
Secondary Hgb A1c Hemoglobin A1c, measured at intake, 6 months, and 1 year. 1 year
Secondary ADL Activities of daily living (Barthel index), measured at intake, 6 months, and 1 year. 1 year
Secondary IADL Instrumental activities of daily living (Lawton scale), measured at intake, 6 months, and 1 year. 1 year
Secondary Physical activity Physical activity / exercise assessment (Modified Kaiser physical activity survey), measured at intake, 6 months, and 1 year. 1 year
Secondary Psychosocial assessment Psychosocial assessment (PAT, Briggs Health), measured at intake, 6 months, and 1 year. 1 year
Secondary Cognitive function Cognitive function test (CPCOG), measured at intake, 6 months, and 1 year. 1 year
Secondary Depression screening Depression screening and/or assessment (MHA depression screening tool), measured at intake, 6 months, and 1 year. 1 year
Secondary Other mental health conditions Other mental health conditions (MHA screening and assessment tools), measured at intake, 6 months, and 1 year. 1 year
Secondary Smoking assessment Smoking / tobacco / nicotine use (No/Yes, with yes triggering LDCT assessment), measured at intake, 6 months, and 1 year. 1 year
Secondary Substance use Substance use or abuse (CAGE), measured at intake, 6 months, and 1 year. 1 year
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