Social Determinants of HealthACTiNNCT05510765
Improving Transportation Assets and the Effects on Wellness Metrics
A study testing Transportation service in people with Social Determinants of Health, run by John M. Salmon IV, MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health
- What is being tested?
- Transportation service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2022to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Lighthouse Community Health Center
Lynchburg, Virginia, 24504
About this study
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.
- Implementation of an Advanced Connected Transportation Network (ACTiN), a novel, collaborative multinetwork transportation model for small cities and rural areas.
- 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).
- Simultaneous evaluation of wellness metrics based on the standards of the CMS Annual Wellness Visit and metrics associated with common chronic diseases.
Read the detailed description
- 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
- 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
- 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
- Conditions
- Social Determinants of Health
- Being tested
- Transportation service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transportation serviceBehavioural
Improved transportation assets applied to all aspects of subjects life
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Low resource, high risk individuals with limited transportation options as a social determinant of health. Receives: Behavioral: Transportation service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rides completed
Total number of rides for test subject per week, averaged over previous 6 months, measured at intake, 6 months, and 1 year.
Measured: 1 year
Cost of transportation
Total cost per mile of transportation, averaged over previous 6 months, measured at intake, 6 months, and 1 year.
Measured: 1 year
Untreated disease(s)
Total number of attributed disease diagnoses that are not being treated, measured at intake, 6 months, and 1 year.
Measured: 1 year
Cancer screening success
Number of eligible cancer screening exams not performed (lung, colon, breast), measured at intake, 6 months, and 1 year.
Measured: 1 year
Secondary outcomes (17)
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.
Measured: 1 year
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.
Measured: 1 year
Prescribed medications
Total number of prescribed medications, measured at intake, 6 months, and 1 year.
Measured: 1 year
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.
Measured: 1 year
Weight
Weight in pounds, measured at intake, 6 months, and 1 year.
Measured: 1 year
BMI
Body mass index, measured at intake, 6 months, and 1 year.
Measured: 1 year
Blood Pressure
Blood Pressure (mmHg), measured at intake, 6 months, and 1 year.
Measured: 1 year
Hgb A1c
Hemoglobin A1c, measured at intake, 6 months, and 1 year.
Measured: 1 year
ADL
Activities of daily living (Barthel index), measured at intake, 6 months, and 1 year.
Measured: 1 year
IADL
Instrumental activities of daily living (Lawton scale), measured at intake, 6 months, and 1 year.
Measured: 1 year
Physical activity
Physical activity / exercise assessment (Modified Kaiser physical activity survey), measured at intake, 6 months, and 1 year.
Measured: 1 year
Psychosocial assessment
Psychosocial assessment (PAT, Briggs Health), measured at intake, 6 months, and 1 year.
Measured: 1 year
Cognitive function
Cognitive function test (CPCOG), measured at intake, 6 months, and 1 year.
Measured: 1 year
Depression screening
Depression screening and/or assessment (MHA depression screening tool), measured at intake, 6 months, and 1 year.
Measured: 1 year
Other mental health conditions
Other mental health conditions (MHA screening and assessment tools), measured at intake, 6 months, and 1 year.
Measured: 1 year
Smoking assessment
Smoking / tobacco / nicotine use (No/Yes, with yes triggering LDCT assessment), measured at intake, 6 months, and 1 year.
Measured: 1 year
Substance use
Substance use or abuse (CAGE), measured at intake, 6 months, and 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John M. Salmon IV, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John M. Salmon IV, MD, Unified Potential, Inc.
- Investigators
- John Salmon, MD, Study director, Medical Director, Lighthouse Community Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510765
- Sponsor's protocol ID
- 4212.081022
- Acronym
- ACTiN
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from all three datasets
Publications
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.
PubMed 21447501Solberg 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.
PubMed 26951583Hood 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.
PubMed 26526164
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05510765
- Acronym / sponsor ID
- ACTiN / 4212.081022
- Conditions
- Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- John M. Salmon IV, MDUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Implementation of an Advanced Connected Transportation Network (ACTiN), a novel, collaborative multinetwork transportation model for small cities and rural areas.
- 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).
- Simultaneous evaluation of wellness metrics based on the standards of the CMS Annual Wellness Visit and metrics associated with common chronic diseases.
Detailed description
- 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
- 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
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Behavioral: Transportation serviceLow resource, high risk individuals with limited transportation options as a social determinant of health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transportation serviceImproved transportation assets applied to all aspects of subjects life | Behavioural | Study arm |
Primary outcome
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.
17 secondary outcomes
Unmet transportation needs
Time frame: 1 year
Unmet medical transportation needs
Time frame: 1 year
Prescribed medications
Time frame: 1 year
Prescribed medications not utilized
Time frame: 1 year
Weight
Time frame: 1 year
BMI
Time frame: 1 year
Blood Pressure
Time frame: 1 year
Hgb A1c
Time frame: 1 year
ADL
Time frame: 1 year
IADL
Time frame: 1 year
Physical activity
Time frame: 1 year
Psychosocial assessment
Time frame: 1 year
Cognitive function
Time frame: 1 year
Depression screening
Time frame: 1 year
Other mental health conditions
Time frame: 1 year
Smoking assessment
Time frame: 1 year
Substance use
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 21447501Bradley 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.
- Background: PubMed 26951583Solberg 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.
- Background: PubMed 26526164Hood 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.
- Individual participant dataSharing planned: Yes. Deidentified data from all three datasets
Related trials for Social Determinants of Health
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
RecruitingObservational study
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Cardiovascular (CV) Risk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Salmon, MD study director
Medical Director, Lighthouse Community Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transportation service in people with Social Determinants of Health, run by John M. Salmon IV, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Salmon, MD (434-847-5050, john@unifiedpotential.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rides completed (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510765, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.