Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Illness Managment | Active Comparator | 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. |
|
| Comorbid Illness Management | Experimental | This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Illness Management | Behavioral | 8 week nursing intervention addressing Congestive Heart Failure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Depression and psychological health will be assessed at week 1, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life | Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning. | Measured at week 1, week 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carolyn L Turvey, PhD MS | VA Medical Center, Iowa City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Medical Center | Iowa City | Iowa | 52246 | United States | ||
| Harry S. Truman Memorial VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22933480 | Result | Turvey C, Sheeran T, Dindo L, Wakefield B, Klein D. Validity of the Patient Health Questionnaire, PHQ-9, administered through interactive-voice-response technology. J Telemed Telecare. 2012 Sep;18(6):348-51. doi: 10.1258/jtt.2012.120220. Epub 2012 Aug 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 8-Week Phone-based Comorbid Illness Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Older Veterans with Heart Failure | Posted | Mean | Standard Deviation | units on a scale | Depression and psychological health will be assessed at week 1, week 8 |
|
8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.
Participants indicating depression were assessed for suicidality and any mortality due to suicide was monitored. These were the only adverse events monitored specifically.
Suicidal ideation was assessed using the Beck Depression Inventory (Question #9) and the Structured Clinical Interview for DSM (Suicidal ideation question).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 8-week Telephone 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide | Psychiatric disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Turvey | Iowa City VA Health Care System | 319 338 0581 | 7714 | Carolyn-Turvey@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comorbid Illness Management | Behavioral | 8 week nursing intervention to address Congestive Heart Failure and emotional coping |
|
| Columbia |
| Missouri |
| 65201-5297 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
|
|
| 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. | Older Veterans with Congestive Heart Failure | Posted | Mean | Standard Deviation | units on a scale | Measured at week 1, week 8 |
|
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | 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 | 0 | 68 | 0 | 68 |
Not provided
Not provided