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
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
This research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF).
Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge burden in the United States in terms of morbidity, mortality, and economic cost. Although disease management programs have been developed to curb these costs and address the complexities of HF management, evaluations of these programs have yielded equivocal results.
With this study the Investigators plan to: (1) to determine the feasibility of telephone delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield, retention, patient acceptance, and patient satisfaction; (2) to determine whether telephone-delivered PST is associated with greater improvements in QoL than telephone-delivered Time Management over 8 weeks; and (3) to determine whether telephone-delivered PST is associated with greater reductions in depressive symptoms and/or greater improvements in self-efficacy or objectively assessed daily physical activity than telephone-delivered Time Management over 8 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Problem-Solving Treatment | Experimental | Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills. |
|
| Time Management | Active Comparator | Time Management is a structured, yet flexible, intervention intended to increase creativity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-Solving Treatment | Behavioral |
| ||
| Time Management |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. | 1 month, 2 months, 3 months, 4 months, 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Depression Inventory | The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. | 1 month, 2 months, 3 months, 4 months, 5 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Cannot speak English
Lack telephone access
Unwilling to be randomized, or
Unavailable for the study period
Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
Planned (within 6 months) cardiac surgery
Cognitive impairment indicative of dementia
Recent (3 months)
Use intravenous inotropic medication
Use an assistive circulatory device
Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)
Currently receiving mental health counseling;
A history of:
Severe depressive symptoms or suicidality
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan A Shaffer, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017748 | Time Management |
| ID | Term |
|---|---|
| D011590 | Psychology, Industrial |
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |