Clinical trial NCT03288194: Improving Quality of Life in Heart Failure
Official title: Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Quality of Life
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-09-19
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Outpatient
* Age \> 21
* Exhibits symptoms of hear failure (NYHA Class II or III)
* Left ventricular ejection fraction (LVEF) \>= 40%
* Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score \< 60

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)

  * acute myocardial infarction,
  * cardiac decompensation, or
  * HF-related hospitalization.
* 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:

  * bipolar disorder,
  * psychosis, or
  * substance abuse/dependency
* Severe depressive symptoms or suicidality

Primary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire
timeFrame: 1 month, 2 months, 3 months, 4 months, 5 months
Secondary outcomes:
measure: Change in Beck Depression Inventory
timeFrame: 1 month, 2 months, 3 months, 4 months, 5 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jonathan A Shaffer, PhD
role: PRINCIPAL_INVESTIGATOR
References: