N/A
Completed N=148
Depression and Congestive Heart Failure in Outpatients.
Source: ClinicalTrials.gov NCT00321269 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Beck Depression Inventory II — 9.3; 9.2; 9.0; 8.6 units on a scale — p=0.90
Summary
Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM group). Participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Depression Inventory II |
9.3; 9.2; 9.0; 8.6 | 0.90 |
| SECONDARY Health-Related Quality of Life |
36.82; 37.2; 36.5; 43.1 | 0.13 |
Eligibility Criteria
Inclusion Criteria
- Receiving treatment for NYHA Class 2-4 heart failure.
- Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.
- Life expectancy greater than 6 months.
- Must speak English.
- Must possess a working telephone.
Exclusion Criteria
- Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).
- Life expectancy less than 3 months.
- Planned relocation to a nursing home.
- Marked visual or hearing impairment.
Data sourced from ClinicalTrials.gov (NCT00321269). 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.