An interventional study of Single Illness Management and Comorbid Illness Management in Heart Failure and Depression, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by VA Office of Research and Development · Not applicable and Interventional
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
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 134 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
This intervention includes standard disease self-management coaching for heart failure and helps patients set goals for fluid management, restricted salt-intake, and medication adherence.
Behavioral: Single Illness Management
This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood.
Behavioral: Comorbid Illness Management
8 week nursing intervention addressing Congestive Heart Failure
8 week nursing intervention to address Congestive Heart Failure and emotional coping
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
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
| Milestone | 8-week Phone Based Single Illness Management | 8-week Phone Based Comorbid Illness Management |
|---|---|---|
| Started | 74 | 74 |
| Completed | 66 | 68 |
| Not completed | 8 | 6 |
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.
| units on a scale | 8-week Phone-based Single Illness Management | 8-week Phone-based Comorbid Illness Management |
|---|---|---|
| Week 1 | 9.3 ± 0.85 | 9.2 ± 0.84 |
| Week 8 | 9.0 ± 0.95 | 8.6 ± 0.96 |
Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.
| units on a scale | 8-Week Phone-Based Single Illness Management | 8-Week Phone-Based Comorbid Illness Management |
|---|---|---|
| Week 1 | 36.82 ± 2.7 | 37.2 ± 2.7 |
| Week 8 | 36.5 ± 2.9 | 43.1 ± 2.9 |
Collected over 8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 8-week Telephone Based Single Illness Management | — | 0/66 (0%) | 0/66 (0%) |
| 8-Week Phone Based Comorbid Illness Management | — | 0/68 (0%) | 0/68 (0%) |
| Event | 8-week Telephone Based Single Illness Management | 8-Week Phone Based Comorbid Illness Management |
|---|---|---|
| SuicidePsychiatric disorders | 0/66 | 0/68 |
| Age, Continuous(years) | 8-week Phone Based Single Illness Management | 8-Week Phone-based Comorbid Illness Management | Total |
|---|---|---|---|
| Mean | 72.4 ± 8.9 | 67.8 ± 9.1 | 70.1 ± 9.0 |
| Sex: Female, Male(Participants) | 8-week Phone Based Single Illness Management | 8-Week Phone-based Comorbid Illness Management | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 65 | 66 | 131 |
| Region of Enrollment(participants) | 8-week Phone Based Single Illness Management | 8-Week Phone-based Comorbid Illness Management | Total |
|---|---|---|---|
| United States | 66 | 68 | 134 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development