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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH041739 | U.S. NIH Grant/Contract | View source | |
| DSIR 82-SEPC |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.
Depression is a serious medical illness that has been associated with increased risk for heart disease and diabetes. Depression may negatively impact aspects of self-care that are required to effectively manage such long-term diseases. In depressed people who have heart disease and/or diabetes, treatment for depression appears to result in only limited improvements in depression symptoms and no improvements in heart disease and diabetes symptoms. An integrated treatment approach may be more effective in improving all three conditions. This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.
Participants in this single-blind study will be randomly assigned to take part in the case management intervention or receive usual care. All participants will attend 5 in-person study evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At study evaluations, blood and urine samples will also be taken. Participants will be asked not to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone calls participants will answer various questions.
The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Treatment as usual |
|
| A | Experimental | Case management intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led case management | Behavioral | The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c | A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large. | Baseline to 12 months |
| Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months | SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms. For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | Measured at Baseline, 6 Months, 12 months |
| Systolic Blood Pressure at Baseline, 6 Months and 12 Months | Systolic Blood Pressure was measured at Baseline, 6 months and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Impairment | Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is "not at all" and 10 is "extremely". This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10. | Measured at Months 6, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne J. Katon, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Cooperative | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21190455 | Result | Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955. | |
| 22230825 | Result | Lin EH, Von Korff M, Ciechanowski P, Peterson D, Ludman EJ, Rutter CM, Oliver M, Young BA, Gensichen J, McGregor M, McCulloch DK, Wagner EH, Katon WJ. Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial. Ann Fam Med. 2012 Jan-Feb;10(1):6-14. doi: 10.1370/afm.1343. |
| Label | URL |
|---|---|
| Related Info | View source |
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Exclusion criteria: terminal illness, residence in long-term care facility, bipolar/schizophrenia, mental confusion suggesting dementia, pregnancy/breast-feeding, use of antipsychotic/mood stabilizer med, severe hearing loss, planned bariatric surgery within 3 months, ongoing psychiatric care
Participants were recruited from may 2007 to october 2009 from 14 primary care clinics of Group Health Cooperative in Washington State
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL |
| FG001 | Care Management Intervention | Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c | A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large. | This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes | Posted | Number | 95% Confidence Interval | unitless | Baseline to 12 months |
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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 | Usual Care | Treatment as usual Treatment as usual: Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Deaths that occurred were not due to the study procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hosptializations | General disorders | Systematic Assessment | Hospitalizations were not the result of the investigation. |
Limitations include the study being completed in one health care system in one geographic area, inadequate power to determine cardiovascular events or rates of hospitalization, potential "spill-over of intervention to usual care patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Wayne Katon, Professor and Vice Chair | Dept Psychiatry, University of Washington Medical School | 206-543-7177 | wkaton@uw.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D003920 | Diabetes Mellitus |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as usual | Behavioral | Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care. |
|
| Measured at Baseline, 6 Months, 12 months |
| LDL Cholesterol at Baseline and 12 Months | LDL Cholesterol was measured at Baseline and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | Measured at Baseline and 12 months |
| Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months | Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | Measured at Baseline, 6 months and 12 months |
| Health Care Costs | Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs | Cumulative outpatient costs over 24 months |
| 22074851 | Result | Von Korff M, Katon WJ, Lin EH, Ciechanowski P, Peterson D, Ludman EJ, Young B, Rutter CM. Functional outcomes of multi-condition collaborative care and successful ageing: results of randomised trial. BMJ. 2011 Nov 10;343:d6612. doi: 10.1136/bmj.d6612. |
| 22566583 | Result | Katon W, Russo J, Lin EH, Schmittdiel J, Ciechanowski P, Ludman E, Peterson D, Young B, Von Korff M. Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial. Arch Gen Psychiatry. 2012 May;69(5):506-14. doi: 10.1001/archgenpsychiatry.2011.1548. |
| 23398269 | Derived | Ludman EJ, Peterson D, Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Young B, Gensichen J. Improving confidence for self care in patients with depression and chronic illnesses. Behav Med. 2013;39(1):1-6. doi: 10.1080/08964289.2012.708682. |
| BG001 | Care Management Intervention | Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Effect Size of Invervention Group to Standard Care | This was an intent to treat analysis calculating the intervention effect size of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes combined |
|
|
|
| Secondary | Functional Impairment | Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is "not at all" and 10 is "extremely". This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10. | Posted | Mean | Standard Deviation | units on a scale | Measured at Months 6, 12 months |
|
|
|
|
| Secondary | Health Care Costs | Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs | Posted | Least Squares Mean | Standard Deviation | US dollars | Cumulative outpatient costs over 24 months |
|
|
|
| Primary | Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months | SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms. For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes | Posted | Mean | Standard Deviation | scores on a scale | Measured at Baseline, 6 Months, 12 months |
|
|
|
|
| Primary | Systolic Blood Pressure at Baseline, 6 Months and 12 Months | Systolic Blood Pressure was measured at Baseline, 6 months and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes | Posted | Mean | Standard Deviation | mmHg | Measured at Baseline, 6 Months, 12 months |
|
|
|
|
| Primary | LDL Cholesterol at Baseline and 12 Months | LDL Cholesterol was measured at Baseline and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes | Posted | Mean | Standard Deviation | mg/dL | Measured at Baseline and 12 months |
|
|
|
|
| Primary | Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months | Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes. | This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes | Posted | Mean | Standard Deviation | percent glycated hemoglobin | Measured at Baseline, 6 months and 12 months |
|
|
|
|
| 2 |
| 108 |
| 23 |
| 106 |
| EG001 | Care Management Intervention | Care management intervention Nurse-led case management: The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. | 1 | 106 | 27 | 105 |
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| D001523 |
| Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002318 | Cardiovascular Diseases |
| SCL-20 at 12 mos |
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| Systolic Blood Pressure at 12 months |
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| Glycated Hemoglobin (HbA1c) at 12 months |
|