Depression and Congestive Heart Failure in Outpatients.



Status:Completed
Conditions:Depression, Depression, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology
Healthy:No
Age Range:45 - Any
Updated:4/21/2016
Start Date:October 2007
End Date:December 2010

Use our guide to learn which trials are right for you!

Depression and CHF in Outpatients

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.

Background:

Between 4 and 5% of patients seen at Veterans Affairs Medical Centers suffer heart failure.
HF is the number one discharge diagnosis within the VHA. One of the most significant
comorbidities in heart failure is depression. Depression predicts increased hospitalization
and mortality even after controlling for key prognostic indicators. This HSR&D study aimed
to test the effectiveness of a psychotherapy intervention for depression combined with
illness management to illness management alone in veterans with heart failure.

Objectives:

To demonstrate better depression, health-related quality-of-life, and adherence outcomes for
an illness management combined with psychotherapy intervention (COMBO) as compared to an
illness management alone program (IMO).

Methods:

This was a two-site, two-arm, randomized controlled trial comparing COMBO to IMO. The total
number of patients recruited for the study was 148. Retention was comparable between groups,
though depression severity predicted drop out in the IMO condition but not the COMBO
condition. Patients completed study assessments at baseline, week 4, week 8
(post-intervention) and at 26- and 52-week follow-up.

Status:

The main study analyses have been conducted. The project team is conducting analysis of
secondary hypotheses

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.
We found this trial at
2
sites
?
mi
from
Columbia, MO
Click here to add this to my saved trials
Iowa City, Iowa 52246
?
mi
from
Iowa City, IA
Click here to add this to my saved trials