Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure

NCT ID: NCT07251894

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

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.

Pilot 1 participants will be asked to complete a baseline survey, and end of study survey, and an end of study semi-structured interview.

Pilot 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.

Pilot 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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Medically Tailored Meals

Participants can choose to receive a weekly delivery of 7, 14, or 21 medically tailored meals at no cost to them for 4 weeks.

Group Type: EXPERIMENTAL

Medically Tailored Meals

Intervention Type: OTHER

Medically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization

Interventions

Medically Tailored Meals

Medically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Have a primary diagnosis of health failure based on ICD code I50* with active hospitalization at time of enrollment
• Must be insured by Medicaid or Medicare or dual eligible
• Ability to read and speak English
• Ability to provide informed consent

Exclusion Criteria

• Are on hospice care or reside in an acute or skilled nursing facility
• Are undergoing evaluation for advanced HF treatments including heart transplant or ventricular assist devices
• Are unable to complete data collection due to cognitive decline or disability (based on the electronic health record or referring provider assessment)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penn Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

859165

Identifier Type: -

Identifier Source: org_study_id