Effects of Social Determinants of Health on IV Iron Treatments (SDOH IV)

November 6, 2024 updated by: Les Louden, BayCare Health System

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33607
        • St. Josephs Hospital Adult Infusion Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients receiving an alternative IV iron product: Sodium ferric gluconate
  • Patients under 18 years of age
  • Patients who do not speak English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Perceptions of IV Iron
Time Frame: Through study completion, an average of 1 year
To study patient perceptions of IV iron treatment dosing (doses received) and administration rates (infusion time).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BayCare Health System

Collaborators

University of South Florida

Investigators

  • Principal Investigator: Les Louden, PharmD, MS, BayCare Health System
  • Principal Investigator: Janelle Applequist, PhD, The University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 7, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024.001-BSJH
  • NIS-ISS-37 SDoH (Other Grant/Funding Number: Pharmacosmos Therapeutics Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Social Determinants of Health (SDOH)

Clinical Trials on Survey using a questionnaire.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe