Major Depression, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.
Interventions
BEHAVIORALTreatment Adherence Intervention
The care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability.
BEHAVIORALEnhanced Care
For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Chronic obstructive pulmonary disease by American Thoracic Society criteria * Major depression by DSM-IV criteria * 17-item Hamilton score \>14 * English speaking
Exclusion criteria
* Inability to give informed consent * MiniMental score \<24 * Aphasia * Nursing home placement after discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Antidepressant Score Scale (CAD) | 28 Weeks | The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | 28 Weeks | The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52. |
Countries
United States
Participant flow
Recruitment details
All subjects were recruited from the Inpatient Pulmonary Rehabilitation Units of the Burke Rehabilitation Hospital and Helen Hayes Rehabilitation Hospital. Recruitment began in March 2002 and ended in January 2008.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Adherence Intervention In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles. | 67 |
| Enhanced Care In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team. | 74 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 11 |
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Too sick medically to continue | 5 | 6 |
| Overall Study | Withdrawal by Subject | 7 | 7 |
Baseline characteristics
| Characteristic | Treatment Adherence Intervention | Enhanced Care | Total |
|---|---|---|---|
| Age Continuous | 71.24 years STANDARD_DEVIATION 8.54 | 71.5 years STANDARD_DEVIATION 8 | 71.4 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 67 participants | 74 participants | 141 participants |
| Sex: Female, Male Female | 42 Participants | 51 Participants | 93 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 74 |
| serious Total, serious adverse events | 38 / 67 | 46 / 74 |
Outcome results
Primary
Composite Antidepressant Score Scale (CAD)
The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.
Time frame: 28 Weeks
Population: Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Treatment Adherence Intervention | Composite Antidepressant Score Scale (CAD) | Adequate Antidepressant Treatment | 29 Participants | 7.4 |
| Treatment Adherence Intervention | Composite Antidepressant Score Scale (CAD) | Non-Adequate Antidepressant Treatment | 9 Participants | — |
| Enhanced Care | Composite Antidepressant Score Scale (CAD) | Adequate Antidepressant Treatment | 25 Participants | 9.3 |
| Enhanced Care | Composite Antidepressant Score Scale (CAD) | Non-Adequate Antidepressant Treatment | 20 Participants | — |
Secondary
Hamilton Depression Rating Scale
The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.
Time frame: 28 Weeks
Population: Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Adherence Intervention | Hamilton Depression Rating Scale | 9.2 points on a scale | Standard Deviation 5.7 |
| Enhanced Care | Hamilton Depression Rating Scale | 12.4 points on a scale | Standard Deviation 6 |