Social Determinants of Health (SDOH)SDOH IVNCT06591182
Effects of Social Determinants of Health on IV Iron Treatments
An observational study of Social Determinants of Health (SDOH), run by BayCare Health System at 1 site in United States.
Trial summary
This study investigates how social determinants of health (SDOH) like income, employment, transportation, food, and housing affect patients' ability to receive IV iron treatments. It aims to understand how these factors influence patients' healthcare behaviors, particularly their attendance at IV iron appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health (SDOH)
- What is being tested?
- Survey using a questionnaire.
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending an appointment for an IV iron infusion at the community hospital infusion clinic on the same day they are being asked to participate in the survey; 18 years of age or older; those who speak English or Spanish.
Who may be able to join
- Patients receiving one of the following IV iron products: Ferric Carboxymaltose, Ferric Derisomaltose, Ferumoxytol, Iron Sucrose, or Iron Dextran
- Patients 18 years of age or older
- Patients who speak English or Spanish
Who cannot join
- Patients receiving an alternative IV iron product: Sodium ferric gluconate
- Patients under 18 years of age
- Patients who do not speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Josephs Hospital - Adult Infusion Centers
Tampa, Florida, 33607
About this study
Official title: Impacts of Social Determinants of Health for Patients Seeking Intravenous Iron Treatments at a Large Community Hospital Adult Infusion Center
This study investigates how social determinants of health (SDOH) like income, employment, transportation, food, and housing affect patients' ability to receive IV iron treatments. It aims to understand how these factors influence patients' healthcare behaviors, particularly their attendance at IV iron appointments.
- Conditions
- Social Determinants of Health (SDOH)
- Being tested
- Survey using a questionnaire.
- Keywords
- Iron, social determinants of health, intravenous iron, patient compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
Observational study, participants are not assigned an intervention as part of the study (Survey using a questionnaire).
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between SDOH and patient compliance
To associate the percentage of patients with self-reported social needs (e.g., social determinants of health) with compliance of IV iron treatments at a large community hospital adult infusion center.
Measurements (social determinants of health) to be explored include: food insecurity, housing instability, utility needs, financial resource strain, transportation challenges, and socio-demographic information. Slightly adapted questions for each measure are derived from the Health Leads Screening Tool, a clinically-validated mechanism for assessing social needs. Questionnaire is structured in a yes/no and Likert scale format.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Patient Perceptions of IV Iron
To study patient perceptions of IV iron treatment dosing (doses received) and administration rates (infusion time).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Nov 2024
- Primary completionJul 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of Health (SDOH)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BayCare Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida
- Responsible party
- Principal investigator, Les Louden, BayCare Health System
- Investigators
- Les Louden, PharmD, MS, Principal investigator, BayCare Health SystemJanelle Applequist, PhD, Principal investigator, The University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591182
- Sponsor's protocol ID
- 2024.001-BSJH
- Other IDs
- NIS-ISS-37 SDoH
- Acronym
- SDOH IV
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Social Determinants of Health for Patients Seeking Intravenous Iron Treatments at a Large Community Hospital Adult Infusion Center
- ClinicalTrials.gov ID
- NCT06591182
- Acronym / sponsor ID
- SDOH IV / 2024.001-BSJH
- Conditions
- Social Determinants of Health (SDOH)
- Keywords
- Iron, social determinants of health, intravenous iron, patient compliance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BayCare Health SystemUniversity, hospital or other
- Collaborators
- University of South Florida
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
This study investigates how social determinants of health (SDOH) like income, employment, transportation, food, and housing affect patients' ability to receive IV iron treatments. It aims to understand how these factors influence patients' healthcare behaviors, particularly their attendance at IV iron appointments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending an appointment for an IV iron infusion at the community hospital infusion clinic on the same day they are being asked to participate in the survey; 18 years of age or older; those who speak English or Spanish.
Key inclusion criteria (3 listed)
- Patients receiving one of the following IV iron products: Ferric Carboxymaltose, Ferric Derisomaltose, Ferumoxytol, Iron Sucrose, or Iron Dextran
- Patients 18 years of age or older
- Patients who speak English or Spanish
Key exclusion criteria (3 listed)
- Patients receiving an alternative IV iron product: Sodium ferric gluconate
- Patients under 18 years of age
- Patients who do not speak English or Spanish
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 |
|---|---|---|
| Survey using a questionnaire.Observational study, participants are not assigned an intervention as part of the study (Survey using a questionnaire). | Other | – |
Primary outcome
Association between SDOH and patient compliance
Time frame: Through study completion, an average of 1 year
To associate the percentage of patients with self-reported social needs (e.g., social determinants of health) with compliance of IV iron treatments at a large community hospital adult infusion center. Measurements (social determinants of health) to be explored include: food insecurity, housing instability, utility needs, financial resource strain, transportation challenges, and socio-demographic information. Slightly adapted questions for each measure are derived from the Health Leads Screening Tool, a clinically-validated mechanism for assessing social needs. Questionnaire is structured in a yes/no and Likert scale format.
1 secondary outcome
Patient Perceptions of IV Iron
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Social Determinants of Health (SDOH)
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)
Not yet recruiting
The Social Needs Assistance for Hospitalized Kids Trial
Social Needs, Health-Related Social Needs
Recruiting
Philly CEAL- DECIDE+ Adaptation
Disparities, Community Health Workers
Not yet recruiting
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth
Recruiting
The e-SINCERE Study
Social Determinants of Health (SDOH), Digital Health Literacy
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.
Les Louden, PharmD, MS principal investigator
BayCare Health System
Janelle Applequist, PhD principal investigator
The University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Determinants of Health (SDOH), run by BayCare Health System 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between SDOH and patient compliance (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.