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OpenTrials
Enrolling by Invitation

NCT Number: NCT06591182

Effects of Social Determinants of Health on IV Iron Treatments

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.

Enrolling by Invitation

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Key information

Conditions

Social Determinants of Health (SDOH) Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Josephs Hospital Adult Infusion Center

Tampa, Florida, 33607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey using a questionnaire.

Other

Observational study, participants are not assigned an intervention as part of the study (Survey using a questionnaire).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

BayCare Health System

Other

Collaborators

  • University of South Florida

Registry information

Official study title

Impacts of Social Determinants of Health for Patients Seeking Intravenous Iron Treatments At a Large Community Hospital Adult Infusion Center

Acronym: SDOH IV

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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