Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool

Sponsor

Methodist Health System (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04701632

Collaborator

(none)

150

Enrollment

Location

36.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound

Detailed Description

The study will review medical records of new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019. These patients were all administered PHQ-9 as part of a quality improvement project. The medical records included for analysis will be from male and female patients aged 18 years or older. The medical records will be reviewed for the following information: general demographics, information including age, sex, ethnicity, race, PHQ-9 score (total and individual items), medical conditions, wound history, past medical history, general symptoms, abuse and suicide risk, activities of daily living, motivation assessment, mental status, and pain ratings. This information will be used to measure the prevalence of clinically significant depression in the sample, which is the primary aim. We will also use the data to establish factors and variables correlated with the presence and severity of clinically significant depression.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool

Actual Study Start Date :

Oct 28, 2019

Anticipated Primary Completion Date :

Nov 14, 2022

Anticipated Study Completion Date :

Nov 14, 2022

Outcome Measures

Primary Outcome Measures

PHQ-9 score [Through study completion, an average of 1 year]
to measure the prevalence of clinically significant depression defined as a PHQ-9 score of equal to or greater than 10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wound care & Hyperbaric Clinic	Dallas	Texas	United States	75203

Sponsors and Collaborators

Methodist Health System

Investigators

Principal Investigator: Asma Khatoon, MD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT04701632

Other Study ID Numbers:

055.WCHC.2019.D

First Posted:

Jan 8, 2021

Last Update Posted:

Feb 4, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Depression

Study Results

No Results Posted as of Feb 4, 2022