Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-01-01 @ 1:12 AM
Study NCT ID:
NCT03560206
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads
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': 'misook.chung@uky.edu', 'phone': '(859) 323-8024', 'title': 'Misook Chung, PhD', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year follow up from the baseline data collection', 'description': 'We reviewed electronic medical records to identify the first event during 1-year follow-up. Adverse events as the first events in this study include death related to cardiovascular health, death with non-cardiac reasons, inpatient hospitalization related to cardiovascular health, and inpatient hospitalization related to non-cardiac reasons.', 'eventGroups': [{'id': 'EG000', 'title': 'Family SWaP Intervention', 'description': "an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.\n\nFamily SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet.", 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'deathsNumAffected': 4, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.\n\nusual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 0, 'seriousNumAtRisk': 158, 'deathsNumAffected': 2, 'seriousNumAffected': 28}], 'seriousEvents': [{'term': 'Cardiac Hospitalization', 'notes': 'Inpatient hospitalization related to cardiovascular health conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 158, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'Non-cardiac Hospitalization', 'notes': 'Inpatient hospitalization related to non-cardiac reasons. We did not collect specific causes of non-cardiac hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'Cardiac death', 'notes': 'Death related to the cardiovascular health condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'Non-cardiac Death', 'notes': 'Death related to non-cardiac death. We did not collect specific causes of non-cardiac death.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Family SWaP Intervention', 'description': "an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.\n\nFamily SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.\n\nusual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4390.2', 'spread': '2286.1', 'groupId': 'OG000'}, {'value': '4048.9', 'spread': '1969.6', 'groupId': 'OG001'}]}]}, {'title': '4-month', 'categories': [{'measurements': [{'value': '3338.1', 'spread': '1580.1', 'groupId': 'OG000'}, {'value': '4402.9', 'spread': '2214.6', 'groupId': 'OG001'}]}]}, {'title': '12-month', 'categories': [{'measurements': [{'value': '3523.1', 'spread': '2173.3', 'groupId': 'OG000'}, {'value': '3855.3', 'spread': '1446.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 year', 'description': 'Baseline: Patient adherence to a sodium-restricted diet was assessed using 24-hour urinary sodium excretion at 3-time points at baseline, 4-months, and 12 months.', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 158 patient-caregiver dyads (158 patients with heart failure and 158 primary caregivers), we report the primary outcome of patient adherence to the sodium-restricted diet. Of the 158 patients with heart failure, 79 patients were randomly assigned to the Family Sodium Watchers intervention group and another 79 patients were assigned to the usual care group.'}, {'type': 'SECONDARY', 'title': 'All Cause Hospitalization/Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Family SWaP Intervention', 'description': "an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.\n\nFamily SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.\n\nusual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.', 'unitOfMeasure': 'first event during follow up', 'reportingStatus': 'POSTED', 'populationDescription': 'Events included death and hospitalization events for participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Family SWaP Intervention', 'description': "an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.\n\nFamily SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.\n\nusual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': "caregivers' health condition and not becoming non-caregiver", 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Busy schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': "patients' new health condition such as cancer", 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'We recruited a total of 316 individuals consisting of 158 patients with heart failure and 158 primary caregivers at outpatient cardiology clinics in one academic medical center and one community medical center.', 'preAssignmentDetails': 'As a result of the screening of 5,365 patients, a total of 819 dyads who met the inclusion criteria and 214 dyads verbally agreed to participate (26.1% recruitment rate). Of these, 199 dyads provided written consent,but 41 dyads withdrew before the home visit for baseline data collection. Thus, only158 dyads (316 individuals: 158 patients and 158 caregivers) completed the baseline assessment. Thus, we reported the final sample of 158 patients with heart failure in this report.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Family SWaP Intervention', 'description': "an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.\n\nFamily SWaP intervention with mini iPad: The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet."}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.\n\nusual care: The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.'}, {'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': '100', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '158 patients and 158 caregivers participated in this dyadic research. We report age, gender, and ethnicity for total individuals by combining patients and caregivers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-11', 'size': 595666, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-10-15T09:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2015-01-06', 'resultsFirstSubmitDate': '2021-10-15', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-02', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' Adherence to Sodium-restricted Diet Assessed by Urinary Sodium Excretion Levels", 'timeFrame': 'Up to 1 year', 'description': 'Baseline: Patient adherence to a sodium-restricted diet was assessed using 24-hour urinary sodium excretion at 3-time points at baseline, 4-months, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'All Cause Hospitalization/Mortality', 'timeFrame': '12 months', 'description': 'Data for all events of hospitalizations and mortality were collected from the baseline to 12 months follow up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet, low-sodium', 'caregivers'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The Family Sodium Watcher program in this study is designed to improve adherence to a sodium restricted diet in patients with HF using strategies that educate both patients and family caregivers about sodium monitoring and that stress a gradual progressive adaptation to low sodium food for both patients and family caregivers.', 'detailedDescription': 'Heart failure (HF) emerged as a significant public health threat in the 1990s and has now reached epidemic proportions. Despite advances in the medical treatment of HF, patients with HF face frequent hospitalizations for acute exacerbations. Inadequate self-care strategies, in particular non-adherence to a sodium restricted diet (SRD), is a main cause of these rehospitalizations. Prior interventions to increase adherence have focused on increasing knowledge about restricting sodium in the diet have met with limited success. Unaddressed by these interventions are the major barriers of measuring and tracking daily sodium intake, family members who continue to eat high sodium diets, and a preference for salty foods-particularly in the elderly who have a decreased sense of taste. It is possible to retrain the taste buds to enjoy low salt foods by gradually reducing the amount of sodium in foods over the course of 16 weeks. This retraining works best with direct involvement and support from family members. The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a SRD by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible patients will:\n\n* have diagnosis of chronic HF with either preserved or reduced ejection fraction\n* have a dedicated primary family caregiver\n* be able to speak and write English\n\nEligible caregivers will:\n\n* be a primary caregiver identified by the patient\n* the spouse, committed partner, or family member living with the HF patient\n* be able to speak and understand English\n* have no obvious major clinical cognitive impairment that would impair ability to give informed consent\n* have no major co-morbidities (i.e. HF, cancer, renal/liver failure, or uncontrolled diabetes as determined by self-report).\n\nExclusion Criteria:\n\nPatients will be excluded if they have:\n\n* major clinical cognitive impairment (i.e., dementia, Alzheimer disease, and severe stroke)\n* a co-existing terminal illness (e.g., cancer)\n* a referral for heart transplantation\n* a dietary prescription that prevents following a 2-3 gram sodium diet (e.g., clinician does not support use of a SRD).\n* no dedicated caregivers'}, 'identificationModule': {'nctId': 'NCT03560206', 'acronym': 'FAMSWAP', 'briefTitle': 'Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Effects of Family Sodium Watcher Program on Outcomes in Heart Failure Patient-Family Caregiver Dyads', 'orgStudyIdInfo': {'id': '46045'}, 'secondaryIdInfos': [{'id': 'R01NR012967', 'link': 'https://reporter.nih.gov/quickSearch/R01NR012967', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family SWaP intervention', 'description': "an educational-behavioral intervention consisting of 6 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions (15-20 minutes) that will be held at the dyad's preferred time delivered to their homes using a video conferencing program through a mini iPad.", 'interventionNames': ['Behavioral: Family SWaP intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.', 'interventionNames': ['Behavioral: usual care']}], 'interventions': [{'name': 'Family SWaP intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Family SWaP'], 'description': 'The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet.', 'armGroupLabels': ['Family SWaP intervention']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'description': 'The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky HealthCare', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Misook L Chung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misook L. Chung', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Misook L. Chung', 'investigatorAffiliation': 'University of Kentucky'}}}}