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NCT05345054 · ClinicalTrials.gov registry record
The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health
A clinical trial of Colorectal Cancer and Inflammatory Bowel Diseases, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 120
- Enrollment target
- 3
- Study locations
NCT05345054 is a study of Colorectal Cancer and Inflammatory Bowel Diseases that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 120 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT05345054, a study of Colorectal Cancer and Inflammatory Bowel Diseases, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population. Objectives: While socioecological determinants of health (SEDOH) such as health literacy and socioeconomic status are known drivers of surgical disparities, an estimated 36-47% of surgical disparities remains unexplained. This gap results from limitations of current clinical datasets in capturing SEDOHs. This pilot study aims to fill this gap by (i) collecting granular SEDOH data, (ii) identifying barriers to surgical care for older African Americans, and (iii) establishing a multi-institutional clinical database through a socioecological context. These findings will help understand how SEDOHs drive surgical disparities and inform development of interventions to eliminate them in elderly African Americans. Design and Methods: Guided by the socioecological model of health, the investigators will use mixed-methods to achieve the objectives. First, the investigators will assess the acceptability and feasibility of a 58-item SEDOH survey based on the NIH PhenX toolkit. After distributing this survey to 36 elderly (≥65 years) African American patients undergoing surgery at 3 rural, UAB-affiliated hospitals (Alex-City, Greenville, Demopolis) the investigators will conduct detailed theory guided assessments of acceptability and feasibility (SA1). Second, the investigators will conduct key informant interviews of individuals from all 5 socioecological levels at each rural hospital (n=10) to identify additional barriers and facilitators to surgical care. The investigators will purposively sample 100% of participants at the patient and caregiver level (n=12) to be elderly African Americans (SA2). Finally, the investigators will link measured SEDOH data with standardized clinical data at each hospital to establish a
Conditions Studied
Interventions
- OTHER no intervention
Study Locations (3)
Alabama
- Russell Medical Center - Alexander City
- Whitfield Regional Medical Center - Demopolis
- Regional Medical Center of Central Alabama - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2023-08-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05345054
The ClinicalTrials.gov registry entry for NCT05345054 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (92% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which no intervention is the first listed.
NCT05345054 reports 3 study locations spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT05345054 about?
NCT05345054 is a clinical study titled "The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health". Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population. Objectives: While socioecological de...
What is the current status of trial NCT05345054?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2022-08-01. Estimated completion is 2023-08-12.
What conditions does trial NCT05345054 study?
This clinical trial studies the following conditions: Colorectal Cancer, Inflammatory Bowel Diseases, Social Behavior, Diverticular Diseases.
What interventions are being tested in trial NCT05345054?
The interventions under investigation include: no intervention (OTHER).
Who is sponsoring clinical trial NCT05345054?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05345054 being conducted?
This trial has 3 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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