Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT03493204
Status:
COMPLETED
Last Update Posted:
2019-08-30
First Post:
2018-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D001201', 'term': 'Ascites'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of hospital-bed days in 12 weeks', 'timeFrame': 'From date of randomization until 12 weeks', 'description': 'The number of days the participants were hospitalized after randomization'}, {'measure': 'Change in diuretic dose', 'timeFrame': 'baseline, week 12', 'description': "The dose amount changes the participant's medications that are considered diuretics"}, {'measure': 'Change in frailty measures', 'timeFrame': 'baseline, week 12', 'description': 'Change in the hand grip strength using a hand-held dynamometer. The device will be squeezed 3 times with their dominant hand and the force measured in kilograms. The best recorded value (highest force number) will be their value.'}, {'measure': 'Change in frailty measures', 'timeFrame': 'baseline, week 12', 'description': 'Change in time taken to walk 5 meters (walk speed measured in meters per second)'}, {'measure': 'Quality of life', 'timeFrame': 'baseline, week 12', 'description': 'Change in Visual Analog Scale. The subject selects how their health is today by marking an X on the scale from 0-100; 0= worst imaginable health state / 100= best imaginable health state'}], 'primaryOutcomes': [{'measure': 'Number of therapeutic paracenteses', 'timeFrame': 'From date of randomization until 12 weeks', 'description': 'Number of paracenteses'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life', 'timeFrame': 'baseline, week 12', 'description': "Measured by Ascites Symptom Inventory (ASI-7). This is a 7 question scale that measures the subject's symptoms with a value from 0-4 (0=does not apply / 4=very strong applies). The higher the subject's score the worse the subject's symptoms. The mean change will be compared between groups."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Encephalopathy', 'Ascites', 'Liver Diseases', 'Cirrhosis'], 'conditions': ['Hepatic Encephalopathy', 'Ascites', 'Liver Diseases', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years or older of age\n* Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:\n\n 1. liver biopsy, OR\n 2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR\n 3. 2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score \\>13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) \\>2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices\n* 3\\) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days\n\nExclusion Criteria:\n\n* Language barriers that cannot be surmounted with in-person interpreters\n* Estimated life expectancy \\< 3 months\n* Pregnancy (self-reported)\n* Unable or unwilling to provide consent\n* History of liver transplant\n* Planned discharge to nursing facility\n* Anuria or serum creatinine \\> 2.0 mg/dL\n* Uncontrolled hepatic encephalopathy'}, 'identificationModule': {'nctId': 'NCT03493204', 'briefTitle': 'Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial', 'orgStudyIdInfo': {'id': 'HUM00141457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-delivered, salt restricted', 'description': 'Meal description: salt-restricted (1500 mg to 2000 mg daily), \\> 2100 kilocalorie, high protein (\\>80 g daily) in addition to receiving standard pamphlet receipt', 'interventionNames': ['Other: Meal delivery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Advice', 'description': 'Standard of care, advice on salt-restriction using standard pamphlet receipt', 'interventionNames': ['Other: Standard pamphlet with Dietary Advice']}], 'interventions': [{'name': 'Meal delivery', 'type': 'OTHER', 'description': 'The food will be pre-packaged for storage and patient will prepare these meals at home', 'armGroupLabels': ['Home-delivered, salt restricted']}, {'name': 'Standard pamphlet with Dietary Advice', 'type': 'OTHER', 'description': 'Explains how to maintain a low-sodium diet', 'armGroupLabels': ['Dietary Advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Elliot Tapper', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine', 'investigatorFullName': 'Elliot B. Tapper', 'investigatorAffiliation': 'University of Michigan'}}}}