NCT04701632

Brief Summary

The objective of the study is to complete a retrospective chart review of subjects who were treated at the Wound Care Clinic at Methodist Dallas Medical Center, presented for treatment between June 2018 and February 2019, and were administered the PHQ-9. The study aims to measure the prevalence of depression in this sample, feasibility of using PHQ-9 in this patient population, and identifying variables and functional impairment associated with clinically significant depression.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

November 4, 2019

Last Update Submit

February 3, 2022

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

  • PHQ-9 score

    to measure the prevalence of clinically significant depression defined as a PHQ-9 score of equal to or greater than 10.

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019.

You may qualify if:

  • Age 18 or older
  • Received care at the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019
  • Completed a PHQ-9 form at the time of initial evaluation/examination

You may not qualify if:

  • \. Patients less than 18 years of age will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wound care & Hyperbaric Clinic

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Asma Khatoon, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

January 8, 2021

Study Start

October 28, 2019

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

February 4, 2022

Record last verified: 2022-02

Locations

US(1)