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

Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04701632
• Other study ID #: 055.WCHC.2019.D
• Status: Active, not recruiting
• Start date: October 28, 2019
• Est. completion date: November 14, 2022

Study information

• Verified date: February 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. Received care at the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019

3. Completed a PHQ-9 form at the time of initial evaluation/examination

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Depression
• Wound
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Wound care & Hyperbaric Clinic	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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