- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251894
Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure (HF-MTM)
HF-MTM Pilot: Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Medically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the MTM intervention
Time Frame: From enrollment to the end of the intervention at 4 weeks for Pilot 1
|
The % of meals successfully delivered to the patient, where a 75% rate of successful delivery indicates feasibility.
|
From enrollment to the end of the intervention at 4 weeks for Pilot 1
|
|
Acceptability of the MTM intervention as measured by the Net Promoter Score
Time Frame: At the end of the intervention at 4 weeks for Pilot 1.
|
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)
|
At the end of the intervention at 4 weeks for Pilot 1.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 859165
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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