Improving Quality of Life in Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03288194|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Quality of Life||Behavioral: Problem-Solving Treatment Behavioral: Time Management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial|
|Actual Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Problem-Solving Treatment
Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.
Behavioral: Problem-Solving Treatment
Active Comparator: Time Management
Time Management is a structured, yet flexible, intervention intended to increase creativity.
Behavioral: Time Management
- Change in Kansas City Cardiomyopathy Questionnaire [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months ]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.
- Change in Beck Depression Inventory [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288194
|Contact: Jonathan A Shaffer, PhDfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado||Recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Jonathan A Shaffer, PhD 303-556-2312 email@example.com|
|Principal Investigator:||Jonathan A Shaffer, PhD||University of Colorado, Denver|