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Trial record 31 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Depression Outpatient Cardiology Screening Study (DOCS)

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ClinicalTrials.gov Identifier: NCT01552889
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Coronary Heart Disease
Intervention Behavioral: Collaborative Care
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care (UC) Collaborative Care (CC)
Hide Arm/Group Description Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.

Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.

Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.

Period Title: Overall Study
Started 101 100
Completed 90 95
Not Completed 11 5
Arm/Group Title Usual Care (UC) Collaborative Care (CC) Total
Hide Arm/Group Description Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.

Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.

Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.

Total of all reporting groups
Overall Number of Baseline Participants 101 100 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 201 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
  57.4%
64
  64.0%
122
  60.7%
>=65 years
43
  42.6%
36
  36.0%
79
  39.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 100 participants 201 participants
63.1  (10.0) 63.0  (9.5) 63.05  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 201 participants
Female
37
  36.6%
47
  47.0%
84
  41.8%
Male
64
  63.4%
53
  53.0%
117
  58.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants 100 participants 201 participants
101 100 201
1.Primary Outcome
Title Beck Depression Inventory 2
Hide Description Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (UC) Collaborative Care (CC)
Hide Arm/Group Description:
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.

Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.

Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.

Overall Number of Participants Analyzed 101 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.4  (9.0) 15.9  (8.8)
2.Secondary Outcome
Title Treatment Satisfaction Scale.
Hide Description This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Collaborative Care
Hide Arm/Group Description:
Same as above
Same as above
Overall Number of Participants Analyzed 101 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (1.3) 4.0  (1.1)
3.Secondary Outcome
Title PROMIS Physical Functioning Scale 10a Short Form
Hide Description This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Collaborative Care
Hide Arm/Group Description:
Same as above
Same as above
Overall Number of Participants Analyzed 101 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
39.6  (4.9) 39.2  (4.5)
Time Frame One year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care (UC) Collaborative Care (CC)
Hide Arm/Group Description Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.

Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.

Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.

All-Cause Mortality
Usual Care (UC) Collaborative Care (CC)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/101 (7.92%)   1/100 (1.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care (UC) Collaborative Care (CC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care (UC) Collaborative Care (CC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/100 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Robert Carney
Organization: Washington University School of Medicine
Phone: 314-286-1313
Responsible Party: Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01552889     History of Changes
Other Study ID Numbers: 201105510
First Submitted: March 9, 2012
First Posted: March 13, 2012
Results First Submitted: January 25, 2017
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017