Depression, Heart Failure
Conditions
Keywords
Home Monitoring, Heart Failure, Depression
Brief 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.
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
Interventions
BEHAVIORALSingle Illness Management
8 week nursing intervention addressing Congestive Heart Failure
BEHAVIORALComorbid Illness Management
8 week nursing intervention to address Congestive Heart Failure and emotional coping
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory II | Depression and psychological health will be assessed at week 1, week 8 | Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | Measured at week 1, week 8 | Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 8-week Phone Based Single Illness Management Standard nursing intervention to treat Congestive Heart Failure
Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure | 66 |
| 8-Week Phone-based Comorbid Illness Management Nursing intervention to treat Congestive Heart Failure and emotional coping
CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping | 68 |
| Total | 134 |
Baseline characteristics
| Characteristic | 8-week Phone Based Single Illness Management | 8-Week Phone-based Comorbid Illness Management | Total |
|---|---|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 8.9 | 67.8 years STANDARD_DEVIATION 9.1 | 70.1 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 66 participants | 68 participants | 134 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 65 Participants | 66 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 68 |
| serious Total, serious adverse events | 0 / 66 | 0 / 68 |
Outcome results
Primary
Beck Depression Inventory II
Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.
Time frame: Depression and psychological health will be assessed at week 1, week 8
Population: Older Veterans with Heart Failure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 8-week Phone-based Single Illness Management | Beck Depression Inventory II | Week 8 | 9.0 units on a scale | Standard Deviation 0.95 |
| 8-week Phone-based Single Illness Management | Beck Depression Inventory II | Week 1 | 9.3 units on a scale | Standard Deviation 0.85 |
| 8-week Phone-based Comorbid Illness Management | Beck Depression Inventory II | Week 1 | 9.2 units on a scale | Standard Deviation 0.84 |
| 8-week Phone-based Comorbid Illness Management | Beck Depression Inventory II | Week 8 | 8.6 units on a scale | Standard Deviation 0.96 |
Comparison: Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\>F=0.90.p-value: 0.9Mixed Models Analysis
Secondary
Health-Related Quality of Life
Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.
Time frame: Measured at week 1, week 8
Population: Older Veterans with Congestive Heart Failure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 8-week Phone-based Single Illness Management | Health-Related Quality of Life | Week 1 | 36.82 units on a scale | Standard Deviation 2.7 |
| 8-week Phone-based Single Illness Management | Health-Related Quality of Life | Week 8 | 36.5 units on a scale | Standard Deviation 2.9 |
| 8-week Phone-based Comorbid Illness Management | Health-Related Quality of Life | Week 1 | 37.2 units on a scale | Standard Deviation 2.7 |
| 8-week Phone-based Comorbid Illness Management | Health-Related Quality of Life | Week 8 | 43.1 units on a scale | Standard Deviation 2.9 |
p-value: 0.13Mixed Models Analysis