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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL071992-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Adherence Intervention | Experimental | In the Treatment Adherence Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease treatment adherence and to help the participant overcome those obstacles. |
|
| Enhanced Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Adherence Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George S Alexopoulos, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Hayes Hospital | West Haverstraw | New York | 10993 | United States | ||
| Burke Rehabilitation Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40960814 | Derived | Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Enhanced Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Participants | 28 Weeks |
|
1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment.
This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Medication Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George S. Alexopoulos, M.D. | Weill Cornell Medical College | 914-997-5767 | gsalexop@med.cornell.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| Enhanced Care | Behavioral | 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. |
|
| White Plains |
| New York |
| 10605 |
| United States |
| Weill Medical College of Cornell University | White Plains | New York | 10605 | United States |
| Too sick medically to continue |
|
| Withdrawal by Subject |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | 28 Weeks |
|
|
|
| 38 |
| 67 |
| 0 |
| 67 |
| EG001 | 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. | 46 | 74 | 0 | 74 |
| Atrial Fibrilation | Cardiac disorders | Non-systematic Assessment |
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| Back surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Brain cancer | General disorders | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | Non-systematic Assessment |
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| Cervical cancer | General disorders | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Debility | General disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
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| Edema | Renal and urinary disorders | Non-systematic Assessment |
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| Exacerbation of chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Heart attack | Cardiac disorders | Non-systematic Assessment |
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| Heart surgery | Cardiac disorders | Non-systematic Assessment |
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| High potassium levels | General disorders | Non-systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Inpatient psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Loss of consciousness/fainting | General disorders | Non-systematic Assessment |
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| Lung Cancer | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
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| Staph infection | Infections and infestations | Non-systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Total knee replacement | Surgical and medical procedures | Non-systematic Assessment |
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| Unknown case of death | General disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |