N/A
N=214
Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00468676 ↗Enrolled (actual)
214
Serious AEs
1.4%
Results posted
May 2014
Primary outcome: Primary: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c — -1.57 unitless — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nurse-led case management (Behavioral); Treatment as usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c |
-1.57 | .001 sig |
| PRIMARY Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months |
1.65; 1.74; 1.26; 0.84; 1.14; 0.83 | <0.001 sig |
| PRIMARY Systolic Blood Pressure at Baseline, 6 Months and 12 Months |
131.9; 135.7; 133.5; 131.9; 132.3; 131.0 | — |
| PRIMARY LDL Cholesterol at Baseline and 12 Months |
109.4; 106.8; 101.4; 91.9 | — |
| PRIMARY Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months |
8.04; 8.14; 7.87; 7.42; 7.81; 7.33 | — |
| SECONDARY Functional Impairment |
4.2; 3.7; 4.5; 3.8 | <0.01 sig |
| SECONDARY Health Care Costs |
21,513; 20,918 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00468676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.