Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
Study NCT ID:
NCT04938661
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-05-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-27', 'size': 519128, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-07T08:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '3 Months', 'description': 'VO2 peak'}, {'measure': 'Number of participants who are re-hospitalized during the trial', 'timeFrame': '1 Year', 'description': 'We will look at the number of patients who are hospitalized for any reason during the follow-up period'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': '3 Months', 'description': 'body weight will be measured from pre to post intervention to see if weight decreases'}, {'measure': 'Fasting Basic Lipid Panel', 'timeFrame': '3 Months', 'description': 'All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.'}, {'measure': 'Fasting Blood Glucose', 'timeFrame': '3 Months', 'description': 'All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.'}, {'measure': 'Fasting Hemoglobin', 'timeFrame': '3 Months', 'description': 'All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.'}, {'measure': 'Fasting Hemoglobin A1C', 'timeFrame': '3 Months', 'description': 'All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.'}, {'measure': '6 Minute Walk Test', 'timeFrame': '3 Months', 'description': 'exercise capacity'}, {'measure': 'Self-Reported Physical Activity', 'timeFrame': '3 Months', 'description': 'assessed via IPAQ questionnaire'}, {'measure': 'Self-Reported Physical Activity', 'timeFrame': '3 Months', 'description': 'assessed via DASI questionnaire'}, {'measure': 'Self-Reported Dietary Patterns', 'timeFrame': '3 Months', 'description': 'obtained using a standard food frequency questionnaire'}, {'measure': 'Self-Reported Quality of Life', 'timeFrame': '3 Months', 'description': 'Assessed using PHQ-9'}, {'measure': 'Self-Reported Quality of Life', 'timeFrame': '3 Months', 'description': 'Assessed using Darmouth 9-item short-form health survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehabilitation'], 'conditions': ['Acute Myocardial Infarction', 'Acute Coronary Syndrome', 'Stable Angina Pectoris', 'Percutaneous Coronary Intervention', 'Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.', 'detailedDescription': 'To address our specific aims we will use a single-center, prospective, three-arm, parallel group, randomized controlled trial design. At the time of identification of eligibility for participation, patients will be randomized to one of three arms (1:1:1 ratio): Arm 1 consists of patients randomized to conventional cardiac rehab only, Arm 2 consists of patients randomized to conventional cardiac rehab with the addition of the mHealth platform, and Arm 3 consists of patients randomized to remote case management using the mHealth platform only. Clinical metrics will include traditional cardiovascular risk factors with additional tracking of service utilization and adherence, and quality of life. Measures will be made at baseline (pre-intervention) and \\~3-months (coinciding with completion of conventional CR). Additional follow-up will occur at 12 months post CR entry. Randomization to study arms will be done with a multidimensional dynamic allocation algorithm, minimizing imbalances in age, sex, body mass index, and race across study arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Own or have reliable access to a smartphone or desktop computer with internet access\n* Have an email address\n* Patients who have a history of one of the following; acute myocardial infarction/acute coronary syndrome, stable angina pectoris, percutaneous coronary intervention, or heart failure.\n* Patients who have undergone a surgical procedure which includes an indication for cardiac rehabilitation (coronary artery bypass surgery, heart valve repair/replacement, or heart transplant)\n\nExclusion Criteria:\n\n* Patients referred to cardiac rehab with ventricular assist devices.'}, 'identificationModule': {'nctId': 'NCT04938661', 'acronym': 'iCARE', 'briefTitle': 'Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)', 'orgStudyIdInfo': {'id': '20-002258'}, 'secondaryIdInfos': [{'id': 'R01NR018832', 'link': 'https://reporter.nih.gov/quickSearch/R01NR018832', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Center-Based Cardiac Rehab (CON)', 'description': 'Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.', 'interventionNames': ['Other: Center-Based Cardiac Rehab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Center-Based Cardiac Rehab + mHealth (CON+)', 'description': 'Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.', 'interventionNames': ['Other: Center-Based Cardiac Rehab', 'Other: mHealth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home-Based Cardiac Rehab + mHealth (HOM+)', 'description': 'Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.', 'interventionNames': ['Other: mHealth', 'Other: Home-Based Cardiac Rehab']}], 'interventions': [{'name': 'Center-Based Cardiac Rehab', 'type': 'OTHER', 'description': '36 center-Based Cardiac Rehab Sessions', 'armGroupLabels': ['Conventional Center-Based Cardiac Rehab (CON)', 'Conventional Center-Based Cardiac Rehab + mHealth (CON+)']}, {'name': 'mHealth', 'type': 'OTHER', 'description': 'Mobile Health Platform', 'armGroupLabels': ['Conventional Center-Based Cardiac Rehab + mHealth (CON+)', 'Home-Based Cardiac Rehab + mHealth (HOM+)']}, {'name': 'Home-Based Cardiac Rehab', 'type': 'OTHER', 'description': 'Encouraged to exercise 3 times per week at home', 'armGroupLabels': ['Home-Based Cardiac Rehab + mHealth (HOM+)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Thomas P Olson, Ph.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Thomas P. Olson, M.S., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}