Coronary Heart Disease, Depression
Conditions
Brief summary
This study compares the effects of depression screening and case management to usual care in cardiology outpatients with documented evidence of coronary heart disease. Despite strong evidence that depression is a risk factor for cardiac events, there is insufficient evidence to support the use of depression screening in cardiac patients.
Detailed description
Depression and cardiovascular disease are highly comorbid, and depression is a risk factor for psychosocial morbidity, poor adherence to medical treatment regimens, physical inactivity, poor physical functioning, and medical morbidity and mortality in cardiac patients, especially following an acute coronary syndrome (ACS). The American Heart Association recently recommended that all cardiac patients be screened for depression in order to improve identification and treatment of this risk factor. Patients are screened for depression during an outpatient cardiology visit and those that screen positive will be contacted for enrollment into this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician (PCP), the cardiologist and the nurse case manager, or usual care (the patient is informed he/she screened positive for depression and is advised to contact their PCP and/or cardiologist). The PCP and/or cardiologist are free to evaluate, treat and refer that patient to mental health services as they deem necessary. Patients in both groups will be monitored for depression severity and duration at 3, 6 and 12 months after enrollment. The course of their depression since enrollment or last follow-up includes remissions, new onsets, relapses, recurrences, and treatment will be determined.
Interventions
BEHAVIORALCollaborative 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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* recent history of Acute Coronary Syndrome or other cardiac event or documented heart disease * score of 10 or higher on the Patient Health Questionnaire
Exclusion criteria
* suicidal ideation or behavior * cognitive impairment or inability to read or speak English * schizophrenia, bipolar disorder * active substance abuse or alcoholism * severe valvular disease, severe congestive heart failure, malignancy * physical limitations that would interfere with participation in the study * medical contraindications to the use of available antidepressants * participation in a competing research protocol * physician or patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory 2 | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Scale. | 12 months | This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale. |
| PROMIS Physical Functioning Scale 10a Short Form | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (UC) Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study. | 101 |
| 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. | 100 |
| Total | 201 |
Baseline characteristics
| Characteristic | Collaborative Care (CC) | Usual Care (UC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 43 Participants | 79 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 58 Participants | 122 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 9.5 | 63.1 years STANDARD_DEVIATION 10 | 63.05 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 100 participants | 101 participants | 201 participants |
| Sex: Female, Male Female | 47 Participants | 37 Participants | 84 Participants |
| Sex: Female, Male Male | 53 Participants | 64 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 101 | 1 / 100 |
| other Total, other adverse events | 0 / 101 | 0 / 100 |
| serious Total, serious adverse events | 0 / 101 | 0 / 100 |
Outcome results
Primary
Beck Depression Inventory 2
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Beck Depression Inventory 2 | 17.4 units on a scale | Standard Deviation 9 |
| Collaborative Care (CC) | Beck Depression Inventory 2 | 15.9 units on a scale | Standard Deviation 8.8 |
Secondary
PROMIS Physical Functioning Scale 10a Short Form
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | PROMIS Physical Functioning Scale 10a Short Form | 39.6 units on a scale | Standard Deviation 4.9 |
| Collaborative Care (CC) | PROMIS Physical Functioning Scale 10a Short Form | 39.2 units on a scale | Standard Deviation 4.5 |
Secondary
Treatment Satisfaction Scale.
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Treatment Satisfaction Scale. | 3.3 units on a scale | Standard Deviation 1.3 |
| Collaborative Care (CC) | Treatment Satisfaction Scale. | 4.0 units on a scale | Standard Deviation 1.1 |