Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 11:13 AM
Study NCT ID:
NCT03288194
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Quality of Life in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017748', 'term': 'Time Management'}], 'ancestors': [{'id': 'D011590', 'term': 'Psychology, Industrial'}, {'id': 'D011584', 'term': 'Psychology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '1 month, 2 months, 3 months, 4 months, 5 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Beck Depression Inventory', 'timeFrame': '1 month, 2 months, 3 months, 4 months, 5 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Quality of Life']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nWith 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient\n* Age \\> 21\n* Exhibits symptoms of hear failure (NYHA Class II or III)\n* Left ventricular ejection fraction (LVEF) \\>= 40%\n* Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score \\< 60\n\nExclusion Criteria:\n\n* Cannot speak English\n* Lack telephone access\n* Unwilling to be randomized, or\n* Unavailable for the study period\n* Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or\n* Planned (within 6 months) cardiac surgery\n* Cognitive impairment indicative of dementia\n* Recent (3 months)\n\n * acute myocardial infarction,\n * cardiac decompensation, or\n * HF-related hospitalization.\n* Use intravenous inotropic medication\n* Use an assistive circulatory device\n* Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)\n* Currently receiving mental health counseling;\n* A history of:\n\n * bipolar disorder,\n * psychosis, or\n * substance abuse/dependency\n* Severe depressive symptoms or suicidality'}, 'identificationModule': {'nctId': 'NCT03288194', 'briefTitle': 'Improving Quality of Life in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '15-1619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Problem-Solving Treatment', 'description': 'Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.', 'interventionNames': ['Behavioral: Problem-Solving Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Time Management', 'description': 'Time Management is a structured, yet flexible, intervention intended to increase creativity.', 'interventionNames': ['Behavioral: Time Management']}], 'interventions': [{'name': 'Problem-Solving Treatment', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Problem-Solving Treatment']}, {'name': 'Time Management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Time Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Jonathan A Shaffer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}