Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
Randomized Trial of Liaison Psychiatry in Primary Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Group Health Cooperative
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of diabetes and/or heart disease
- Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
- Diagnosis of major depressive disorder
Exclusion Criteria:
- History of psychosis
- At high risk for suicide
- Cognitive impairment
- Current alcohol or substance abuse disorder
- Does not own a telephone
- Currently seeking psychiatric care
- Pregnant or breastfeeding
- Currently enrolled in a Group Health Cooperative disease management program
- Terminal illness
- Plans to leave Group Health Cooperative in less than a year
- Does not speak English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: B
Treatment as usual
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Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months.
During this time, participants will receive usual care.
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Experimental: A
Case management intervention
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c
Periodo de tiempo: Baseline to 12 months
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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.
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Baseline to 12 months
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Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months
Periodo de tiempo: Measured at Baseline, 6 Months, 12 months
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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
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Systolic Blood Pressure at Baseline, 6 Months and 12 Months
Periodo de tiempo: Measured at Baseline, 6 Months, 12 months
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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. |
Measured at Baseline, 6 Months, 12 months
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LDL Cholesterol at Baseline and 12 Months
Periodo de tiempo: Measured at Baseline and 12 months
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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
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Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months
Periodo de tiempo: Measured at Baseline, 6 months and 12 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Impairment
Periodo de tiempo: Measured at Months 6, 12 months
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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.
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Measured at Months 6, 12 months
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Health Care Costs
Periodo de tiempo: Cumulative outpatient costs over 24 months
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Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs
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Cumulative outpatient costs over 24 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wayne J. Katon, MD, University of Washington
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH041739 (Subvención/contrato del NIH de EE. UU.)
- DSIR 82-SEPC
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