Trial Outcomes & Findings for Depression Outpatient Cardiology Screening Study (NCT NCT01552889)
NCT ID: NCT01552889
Last Updated: 2017-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
12 months
Results posted on
2017-04-27
Participant Flow
Participant milestones
| Measure |
Usual Care (UC)
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
|
Collaborative Care (CC)
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 Study
STARTED
|
101
|
100
|
|
Overall Study
COMPLETED
|
90
|
95
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Depression Outpatient Cardiology Screening Study
Baseline characteristics by cohort
| Measure |
Usual Care (UC)
n=101 Participants
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
|
Collaborative Care (CC)
n=100 Participants
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
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
63.05 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
100 participants
n=7 Participants
|
201 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSelf 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.
Outcome measures
| Measure |
Usual Care (UC)
n=101 Participants
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
|
Collaborative Care (CC)
n=100 Participants
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.
|
|---|---|---|
|
Beck Depression Inventory 2
|
17.4 units on a scale
Standard Deviation 9.0
|
15.9 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 12 monthsThis one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.
Outcome measures
| Measure |
Usual Care (UC)
n=101 Participants
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
|
Collaborative Care (CC)
n=100 Participants
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.
|
|---|---|---|
|
Treatment Satisfaction Scale.
|
3.3 units on a scale
Standard Deviation 1.3
|
4.0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 12 monthsThis 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.
Outcome measures
| Measure |
Usual Care (UC)
n=101 Participants
Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
|
Collaborative Care (CC)
n=100 Participants
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.
|
|---|---|---|
|
PROMIS Physical Functioning Scale 10a Short Form
|
39.6 units on a scale
Standard Deviation 4.9
|
39.2 units on a scale
Standard Deviation 4.5
|
Adverse Events
Usual Care (UC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Collaborative Care (CC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Carney
Washington University School of Medicine
Phone: 314-286-1313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place