N/A Completed N=214 Randomized Single-blind Treatment

Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression

Depression

Source: ClinicalTrials.gov NCT00468676 ↗

Enrolled (actual)

214

Serious AEs

1.4%

Results posted

May 2014

Primary outcomePrimary: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c — -1.57 unitless — p=.001

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.