Depression and Congestive Heart Failure in Outpatients.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure Depression |
Behavioral: Education & behavioral techniques to help CHF patients cope with chronic illness Behavioral: CHF and emotional coping |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Depression and CHF in Outpatients |
- Better outcomes on the measurement of depression and psychological health [ Time Frame: Depression and psychological health will be assessed at week 1, week 4, week 8, week 26 and week 52 ] [ Designated as safety issue: No ]
- Higher health related quality of life, physical functioning and lower heart failure symptom burden, better coping with impairment, self care of heart failure, and sense of personal control [ Time Frame: Measured at week 1, week 4, week 8, week 26 and week 52 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 225 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm 1
Standard nursing intervention to treat Congestive Heart Failure
|
Behavioral: Education & behavioral techniques to help CHF patients cope with chronic illness
8 week nursing intervention addressing Congestive Heart Failure
|
|
Active Comparator: Arm 2
Nursing intervention to treat Congestive Heart Failure and emotional coping
|
Behavioral: CHF and emotional coping
8 week nursing intervention to address Congestive Heart Failure and emotional coping
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Iowa | |
| Iowa City VA Medical Center | |
| Iowa City, Iowa, United States, 52246 | |
| United States, Missouri | |
| Harry S. Truman Memorial VA Medical Center | |
| Columbia, Missouri, United States, 65201-5297 | |
| Principal Investigator: | Carolyn L Turvey, PhD MS | VA Medical Center, Iowa City |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00321269 History of Changes |
| Other Study ID Numbers: | IIR 06-082 |
| Study First Received: | May 1, 2006 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Home Monitoring Heart Failure Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Heart Failure Behavioral Symptoms |
Mood Disorders Mental Disorders Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013