Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-17 @ 12:17 AM
Study NCT ID:
NCT07251894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the MTM intervention', 'timeFrame': 'From enrollment to the end of the intervention at 4 weeks for Pilot 1', 'description': 'The % of meals successfully delivered to the patient, where a 75% rate of successful delivery indicates feasibility.'}, {'measure': 'Acceptability of the MTM intervention as measured by the Net Promoter Score', 'timeFrame': 'At the end of the intervention at 4 weeks for Pilot 1.', 'description': 'Will evaluate the acceptability of the intervention among patients through the Net Promoter Score (scale of 0 to 10; 9-10 being promoters, 7-8 being passives, and 0-6 being detractors)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medically tailored meals', 'Food is medicine', 'Food as medicine', 'Heart failure', 'Diet quality', 'Readmissions'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional pilot study is to evaluate the feasibility, acceptability, and impact of medically tailored meals (MTM) on post-discharge recovery in patients with heart failure for Penn Medicine patients in Philadelphia and Lancaster through two pilots.', 'detailedDescription': 'Pilot 1: Will enroll 30 eligible Penn Medicine patients to receive 4 weeks of medically tailored meals (MTMs) directly to their door. Patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 4 week pilot.\n\nPilot 1 participants will be asked to complete a baseline survey, and end of study survey, and an end of study semi-structured interview.\n\nPilot 2: Will expand upon the learnings from Pilot 1 and be a larger scale longer Food is Medicine (FIM) intervention with patients receiving 8 weeks of MTM deliveries directly to their door. As with Pilot 1, patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 8 week pilot.\n\nPilot 2 participants will be asked to complete a baseline survey, a mid-point survey at 4 weeks, and an end of study survey and semi-structured interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Have a primary diagnosis of health failure based on ICD code I50\\* with active hospitalization at time of enrollment\n* Must be insured by Medicaid or Medicare or dual eligible\n* Ability to read and speak English\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Are on hospice care or reside in an acute or skilled nursing facility\n* Are undergoing evaluation for advanced HF treatments including heart transplant or ventricular assist devices\n* Are unable to complete data collection due to cognitive decline or disability (based on the electronic health record or referring provider assessment)'}, 'identificationModule': {'nctId': 'NCT07251894', 'acronym': 'HF-MTM', 'briefTitle': 'Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'HF-MTM Pilot: Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure', 'orgStudyIdInfo': {'id': '859165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medically Tailored Meals', 'description': 'Participants can choose to receive a weekly delivery of 7, 14, or 21 medically tailored meals at no cost to them for 4 weeks.', 'interventionNames': ['Other: Medically Tailored Meals']}], 'interventions': [{'name': 'Medically Tailored Meals', 'type': 'OTHER', 'description': 'Medically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization', 'armGroupLabels': ['Medically Tailored Meals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Jennifer A Orr, MSPH', 'role': 'CONTACT', 'email': 'Jennifer.Orr@pennmedicine.upenn.edu', 'phone': '2155739179'}, {'name': 'Lauren A. Eberly, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kevin G. Volpp, MD, PhD, FAHA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Penn Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}