Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05205018
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2022-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 432}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-care maintenance', 'timeFrame': '3 months from enrollment', 'description': 'Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2'}], 'secondaryOutcomes': [{'measure': 'Self-care maintenance', 'timeFrame': '6, 9 and 12 months from enrollment', 'description': 'Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2'}, {'measure': 'Self-care monitoring', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Self-care monitoring will be measured with the Self-Care Monitoring Scale of the Self-Care of Heart Failure Index v.7.2'}, {'measure': 'Self-care management', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Self-care monitoring will be measured with the Self-Care Management Scale of the Self-Care of Heart Failure Index v.7.2'}, {'measure': 'Self-Care Self-Efficacy levels', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Self-Care Self-Efficacy will be measured with the Self-Care Self-Efficacy Scale; this scale gives a score from 0 to 100 with higher score meaning higher self-care self-efficacy'}, {'measure': 'Burden of heart failure physical symptoms', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale'}, {'measure': 'Disease specific quality of life', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire'}, {'measure': 'Caregiver contribution to heart failure self-care', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2'}, {'measure': 'Caregiver preparedness', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Will be evaluated with the Caregiver Preparedness Scale'}, {'measure': 'Caregiver burden', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Will be evaluated with the Caregiver Burden Inventory'}, {'measure': 'Health care service uses', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'They will be evaluated with a questionnaire developed by the research team. Specifically wi will evaluate patient mortality, hospitalizations and used of emergency services.'}, {'measure': 'Patient and caregiver generic quality of life', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey'}, {'measure': 'Patient and caregiver anxiety and depression', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'They will ve evaluated with the Hospital Anxiety and Depression Scale'}, {'measure': 'Naturalistic decision making of patients and caregivers', 'timeFrame': '3, 6, 9 and 12 months from enrollment', 'description': 'They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'motivational interviewing', 'self-care', 'self-management', 'behavior change', 'Video calls'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if motivational interviewing, performed remotely through videocalls, is effective to improve self-care in patients with heart failure', 'detailedDescription': 'After signing the informed consent form, patients with heart failure will be assigned to the intervention or control group (1:1). The intervention group will receive a total of seven motivational interviewing sessions over 12 months. The control group will receive the standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. a diagnosis of HF according to international guidelines;\n2. Class II, III or IV in the New York Heart Association (NYHA) functional;\n3. poor self-care, defined as at least two items of the Self-Care Heart Failure Index 7.2 (SCHFI 7.2) with a score of 0, 1 or 2;\n4. age ≥ 18 years;\n5. having an internet access to allow the videocalls;\n6. willingness to sign the informed consent form. -\n\nExclusion Criteria:\n\n1. severe cognitive dysfunction, with a score 0 - 4 on the Six-item screener;\n2. acute coronary events event in the prior three months;\n3. living in nursing homes a residential settings where self-care cannot be performed;\n4. if the patient's informal caregiver is not willing to participate in the study."}, 'identificationModule': {'nctId': 'NCT05205018', 'acronym': 'ReMotivateHF', 'briefTitle': 'Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients', 'orgStudyIdInfo': {'id': '263/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing Arm', 'description': 'This Arm will receive a remote intervention (via videacalls) based on motivational interviewing to improve self-care. The intervention will be delivered seven time over 12 months.', 'interventionNames': ['Behavioral: Motivational interviewing performed remotely through videocalls']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care Arm', 'description': 'This Arm will receive the standard of care.'}], 'interventions': [{'name': 'Motivational interviewing performed remotely through videocalls', 'type': 'BEHAVIORAL', 'description': 'Remote motivational interviewing will be performed seven time over 12 months, through videocalls. The first four interventions will be performed within two months and the following three will be performed at five, eight and eleven months from enrollment.', 'armGroupLabels': ['Motivational Interviewing Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tatiana Bolgeo', 'role': 'CONTACT'}], 'facility': 'Hospital of Alessandria', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}], 'centralContacts': [{'name': 'Ercole Vellone, PhD', 'role': 'CONTACT', 'email': 'ercole.vellone@uniroma2.it', 'phone': '+393387491811'}], 'overallOfficials': [{'name': 'Ercole Vellone, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rome Tor Vergata'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ercole Vellone', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}