Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-28 @ 5:22 AM
Study NCT ID:
NCT00555360
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2007-11-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jpiette@umich.edu', 'phone': '734-845-3626', 'title': 'Dr. John Piette, PhD', 'organization': 'Ann Arbor VA Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard mHealth', 'description': 'Weekly IVR calls for 12 months', 'otherNumAtRisk': 183, 'otherNumAffected': 0, 'seriousNumAtRisk': 183, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'mHealth+Carepartner', 'description': 'Weekly IVR calls for 12 months+feedback to CarePartner', 'otherNumAtRisk': 189, 'otherNumAffected': 0, 'seriousNumAtRisk': 189, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Heart Failure-specific Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard mHealth', 'description': 'Weekly IVR calls for 12 months'}, {'id': 'OG001', 'title': 'mHealth+Carepartner', 'description': 'Weekly IVR calls for 12 months+CarePartner feedback'}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.975', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.74', 'ciLowerLimit': '-4.62', 'ciUpperLimit': '4.77', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'twelve-month followup', 'description': 'Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Revised Heart Failure Self-Care Behavior Scale (HFSCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard mHealth', 'description': 'Weekly IVR calls for 12 months'}, {'id': 'OG001', 'title': 'mHealth+Carepartner', 'description': 'Weekly IVR calls for 12 months+feedback to CarePartner'}], 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '90.5', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.87', 'ciLowerLimit': '-5.78', 'ciUpperLimit': '2.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.7', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'twelve-month follow-up', 'description': 'Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adherent to Heart Failure Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard mHealth', 'description': 'Weekly IVR calls for 12 months'}, {'id': 'OG001', 'title': 'mHealth+Carepartner', 'description': 'Weekly IVR calls for 12 months+feedback to CarePartner'}], 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14', 'ciLowerLimit': '3.9', 'ciUpperLimit': '24.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'twelve-month follow-up', 'description': 'Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.', 'unitOfMeasure': 'percentage of participants/perfect adher', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard mHealth', 'description': 'Weekly IVR calls for 12 months'}, {'id': 'FG001', 'title': 'mHealth Plus CarePartner', 'description': 'Wkly IVR calls for 12 months+feedback to CarePartner'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '36'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard mHealth', 'description': 'Weekly IVR calls for 12 months'}, {'id': 'BG001', 'title': 'mHealth Plus CarePartner', 'description': 'Wkly IVR calls for 12 months+feedback to CarePartner'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '68.1', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Heart Failure-specific Quality of Life', 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '25.1', 'groupId': 'BG000'}, {'value': '41.2', 'spread': '23.7', 'groupId': 'BG001'}, {'value': '40.8', 'spread': '24.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by the Minnesota Living with heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Revised Heart Failure Self-Care Behavior Scale (HFSCB)', 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'spread': '19.3', 'groupId': 'BG000'}, {'value': '83.1', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '83.0', 'spread': '17.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to 145.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Adherent to Heart Failure Medication', 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2007-11-06', 'resultsFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2007-11-07', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-12', 'studyFirstPostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Failure-specific Quality of Life', 'timeFrame': 'twelve-month followup', 'description': 'Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.'}], 'secondaryOutcomes': [{'measure': 'Revised Heart Failure Self-Care Behavior Scale (HFSCB)', 'timeFrame': 'twelve-month follow-up', 'description': 'Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.'}, {'measure': 'Adherent to Heart Failure Medication', 'timeFrame': 'twelve-month follow-up', 'description': 'Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health Information Technology', 'Patient Care Management', 'Self Care', 'Quality of Life', 'Family or non-Family Informal Caregivers'], 'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '23222527', 'type': 'RESULT', 'citation': 'Piette JD, Rosland AM, Marinec NS, Striplin D, Bernstein SJ, Silveira MJ. Engagement with automated patient monitoring and self-management support calls: experience with a thousand chronically ill patients. Med Care. 2013 Mar;51(3):216-23. doi: 10.1097/MLR.0b013e318277ebf8.'}, {'pmid': '26125415', 'type': 'DERIVED', 'citation': 'Piette JD, Striplin D, Marinec N, Chen J, Aikens JE. A randomized trial of mobile health support for heart failure patients and their informal caregivers: impacts on caregiver-reported outcomes. Med Care. 2015 Aug;53(8):692-9. doi: 10.1097/MLR.0000000000000378.'}, {'pmid': '26063161', 'type': 'DERIVED', 'citation': 'Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial. J Med Internet Res. 2015 Jun 10;17(6):e142. doi: 10.2196/jmir.4550.'}]}, 'descriptionModule': {'briefSummary': "Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.", 'detailedDescription': "Background: Heart failure (HF) is a leading cause of preventable hospitalization and death in the VA and many patients fall short of self-care goals. Numerous efficacy trials have shown that HF care management supported by health information technology (i.e., HITCM) can improve patients' outcomes, although VA care managers in 'real-world' health systems are often overwhelmed by the need to provide monitoring and behavior change services. Informal caregivers may help to fill the gaps in VA care management and enhance support for patients' treatment adherence, behavior changes, and symptom monitoring. The challenge will be to identify ways to leverage assistance from informal caregivers (ICGs) who lack the resources to fill this role effectively.\n\nObjectives: We will evaluate the impact of extending the reach of HITCM by incorporating a protocol-driven model for improved monitoring and self-management support by a CarePartner (CP). CPs will be adult children or friends living outside the patient's home who are willing to play a structured role to support self-care. The specific aims of the trial are: (1) to determine whether an intervention that uses automated patient monitoring and behavior change calls with follow-up to HF patients' care manager and CP (HITCM+CP) improves key patient-centered outcomes relative to a system that only uses the same technology to support patients' care management (HITCM-only). Outcomes of interest include patients' health-related quality of life, mental health, health service use, and mortality risk; (2) to evaluate the impact of HITCM+CP on patients' self-care behaviors compared to HITCM-only; and (3) to determine whether the intervention increases the quality and quantity of support for HF patients' self-care compared to HITCM-only.\n\nMethods: 372 HF patient-CP pairs will be recruited from the VA Louis Stokes (Cleveland) Healthcare System. Patients will receive automated telephone assessment and behavior change calls weekly for 12 months. For patients in both study arms, a care manager will monitor patients' assessment results via a secure website and will receive reports concerning urgent health problems by fax and pager. In the HITCM+CP group, patients' CPs also will receive tailored e-mail reports based on patients' weekly assessments. HITCM+CP patients and their CPs will use a structured protocol to review the patient's assessment results, identify self-care goals and barriers, and ensure that the patient's in-home caregivers and healthcare team remain involved. All patients and CPs will complete quantitative surveys at baseline, 6, and 12 months. The study will include a mixed-methods approach including qualitative interviews with patients, CPs and clinicians to evaluate intervention use and the service's potential for translation. The primary outcome will be HF-related quality of life at 12 months. Secondary outcomes will include self-care behavior, patient-CP relationship indicators, hospitalization, and death.\n\nImpact: This study will evaluate a model for leveraging ICGs and structuring their role in HF patients' overall disease management. If effective, the service may provide the frequent monitoring and behavior change assistance that patients need, allowing VA to extend its impact beyond what current care management programs can realistically deliver."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVeterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facilities will be eligible if they have New York Heart Association (NYHA) Class II-III diastolic or systolic HF noted by inpatient or outpatient ICD-9 codes.\n\nExclusion Criteria:\n\nVeterans treated at the VA Louis Stokes (Cleveland) facilities will be ineligible if they:\n\n* have a serious mental illness or cognitive dysfunction, e.g., psychosis, dementia, or active substance abuse (alcohol and/or other drugs);\n* do not speak English fluently;\n* are receiving palliative care due to advanced HF or other health problems;\n* receive the majority of their HF care from providers outside of the VA;\n* are unable to use a telephone to respond to weekly automated self-management support calls; or\n* are unable to nominate an eligible informal caregiver.'}, 'identificationModule': {'nctId': 'NCT00555360', 'briefTitle': 'Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Enhancing Caregiver Support for Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'IIR 07-185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Veterans with heart failure that can identify an out-of-home informal caregiver', 'interventionNames': ['Behavioral: HITCM+CP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Veterans with heart failure that can identify an out-of-home informal caregiver', 'interventionNames': ['Behavioral: HITCM only']}], 'interventions': [{'name': 'HITCM+CP', 'type': 'BEHAVIORAL', 'description': 'Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6-month and 12-month follow-up.', 'armGroupLabels': ['Arm 1']}, {'name': 'HITCM only', 'type': 'BEHAVIORAL', 'description': 'Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48113-0170', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'VA Medical Center, Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'John D. Piette, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}