NCT03863262

Brief Summary

This was an observational study aimed to screen patients with cardiovascular disease for depression in Trinidad and Tobago in a tertiary center and to determine if there is a significant association between patients with symptoms of depression and other comorbidities. Patients (N=1203) were randomly selected from the outpatient cardiology clinics at the Eric Williams Medical Sciences Complex. After fulfilling the inclusion criteria and informed consent were obtained, they were given the case report form which included the Patient Health Questionnaire 9.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

November 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

February 20, 2019

Last Update Submit

November 28, 2019

Conditions

Keywords

cardiovascular

Outcome Measures

Primary Outcomes (1)

  • Percentage of cardiovascular patients with a PHQ9 Score > 10

    The percentage of cardiovascular patients with a screening for depression score \> 10.

    4 months

Secondary Outcomes (1)

  • Demographic associations with a PHQ9 Score >10.

    4 months

Eligibility Criteria

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

The number of participants in this study was 1203 patients. There were no dropped subjects from the study nor were there any incomplete questionnaires by any participants. The sample size for this study was calculated to be 1159 patients. Based on a study done by Huffman, it was estimated that 40% of patients with cardiovascular disease also have depression(2). The Type I error rate 5% (α = 0.05) making the Type II error rate 95% (β = 0.95) with a statistical power of 90%. Assuming a 10% patient decline and attrition rate and a minimum detectable difference of 10%, the estimated sample size was calculated to be 1159 patients.

You may qualify if:

  • Registered patients at Eric Williams Medical Sciences Complex in any of the cardiology outpatient clinics. This was confirmed by matching patients with their registration numbers on the cardiology outpatient clinic appointment listings. These lists are made prior to each cardiology clinic that is scheduled every week on Mondays, Tuesdays, Wednesdays, Thursdays and Fridays.
  • Patients who were 18 years old

You may not qualify if:

  • Patients less than 18 years old
  • Those who did not give informed consent to participate in the study
  • Patients who were not registered patients of the cardiology outpatient clinics at Eric Williams Medical Sciences Complex along
  • Patients who were acutely unwell requiring hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eric Williams Medical Sciences Complex

Port of Spain, North, 00000, Trinidad and Tobago

Location

The University of the West Indies

Saint Augustine, North, 000000, Trinidad and Tobago

Location

Related Publications (6)

  • Huffman JC, Celano CM, Beach SR, Motiwala SR, Januzzi JL. Depression and cardiac disease: epidemiology, mechanisms, and diagnosis. Cardiovasc Psychiatry Neurol. 2013;2013:695925. doi: 10.1155/2013/695925. Epub 2013 Apr 7.

  • Zellweger MJ, Osterwalder RH, Langewitz W, Pfisterer ME. Coronary artery disease and depression. Eur Heart J. 2004 Jan;25(1):3-9. doi: 10.1016/j.ehj.2003.09.009.

  • Whooley MA. Depression and cardiovascular disease: healing the broken-hearted. JAMA. 2006 Jun 28;295(24):2874-81. doi: 10.1001/jama.295.24.2874.

  • Wittkampf K, van Ravesteijn H, Baas K, van de Hoogen H, Schene A, Bindels P, Lucassen P, van de Lisdonk E, van Weert H. The accuracy of Patient Health Questionnaire-9 in detecting depression and measuring depression severity in high-risk groups in primary care. Gen Hosp Psychiatry. 2009 Sep-Oct;31(5):451-9. doi: 10.1016/j.genhosppsych.2009.06.001. Epub 2009 Jul 10.

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  • Seecheran N, Jagdeo CL, Seecheran R, Seecheran V, Persad S, Peram L, Evans M, Edwards J, Thackoorcharan S, Davis B, Davis S, Dawkins B, Dayaram A, De Freitas M, Deonarinesingh T, Dhanai J, Didier C, Motilal S, Baboolal N. Screening for depressive symptoms in cardiovascular patients at a tertiary centre in Trinidad and Tobago: investigation of correlates in the SAD CAT study. BMC Psychiatry. 2020 Oct 8;20(1):498. doi: 10.1186/s12888-020-02909-1.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

March 5, 2019

Study Start

November 8, 2018

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations