Medically Tailored Meals for Heart Failure

(HF-MTM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Hospice care, Nursing facility, Cognitive decline, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether meals specially designed for heart health, known as Medically Tailored Meals, can aid recovery after hospital discharge for heart failure. Participants will receive free meals tailored to their medical needs for four weeks. The trial aims to determine if these meals facilitate adherence to a heart-healthy diet and enhance recovery. Individuals hospitalized for heart failure and insured by Medicaid or Medicare may qualify for this study. As an unphased trial, it offers a unique opportunity to contribute to research that could improve heart health recovery strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that medically tailored meals are safe for heart failure patients?

Studies have shown that medically tailored meals (MTMs) are generally safe for patients. In one study, patients who received MTMs after leaving the hospital reported no major side effects. Another study found that MTMs improved health for patients with heart failure, with no significant negative effects. This suggests that MTMs are well-tolerated and safe for use in similar situations. For those considering joining a trial offering MTMs, current research indicates they are a safe choice for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Medically tailored meals are unique because they offer a personalized dietary approach to managing heart failure, which is different from traditional medications and lifestyle advice. Unlike standard treatments that often rely on drugs to manage symptoms, these meals are specifically designed to meet the nutritional needs of heart failure patients, potentially improving their overall health and quality of life. Researchers are excited about this approach because it emphasizes nutrition as a key component of care, which could lead to better adherence and outcomes for patients without the side effects of medication.

What evidence suggests that medically tailored meals might be an effective treatment for heart failure?

Studies have shown that medically tailored meals (MTMs) greatly benefit people with heart problems. These meals are specifically designed to meet patients' nutritional needs and have been proven to reduce hospital readmissions. Research indicates that MTMs aid recovery after hospital discharge by providing the right nutrients at the right time. Patients who received these meals often experienced better health outcomes and required less healthcare overall. This trial will evaluate the effectiveness of MTMs in supporting recovery in heart failure patients, offering participants a weekly delivery of 7, 14, or 21 medically tailored meals at no cost for 4 weeks. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with heart failure who are currently hospitalized, insured by Medicaid or Medicare, and can consent. It's not for those in hospice care, living in nursing facilities, unable to complete surveys due to cognitive issues, or seeking advanced treatments like transplants.

Inclusion Criteria

Ability to read and speak English

I am 18 years old or older.

I am currently hospitalized with a primary diagnosis of heart failure.

Exclusion Criteria

Are on hospice care or reside in an acute or skilled nursing facility

I am able to complete data collection without issues related to cognitive decline or disability.

I am being considered for advanced heart failure treatments like a transplant or a device to help my heart pump.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals delivered to their door for 4 weeks in Pilot 1 and 8 weeks in Pilot 2

4-8 weeks

Weekly meal deliveries

Follow-up

Participants complete surveys and interviews to assess the impact of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meals

Trial Overview The study tests whether providing medically tailored meals after hospital discharge helps recovery in heart failure patients. Participants will receive these special meals designed to meet their health needs as part of a pilot program in Philadelphia and Lancaster.

How Is the Trial Designed?

Group I: Medically Tailored Meals Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9528877/

The impact of medically tailored meals and nutrition ... Patients at high risk for readmission and food insecurity received up to three months of medically tailored meals and medical nutrition therapy after discharge.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038438

Exploring Facilitators and Barriers of Medically Tailored ... Implementing medically tailored meal (MTM) interventions may help to optimize nutrition and improve outcomes for patients with AHF. This study ...

3. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... Medically tailored meals (MTMs) can reduce health care use among high-risk patients with diet-related conditions.

4. journals.lww.com journals.lww.com/lww-medicalcare/fulltext/2022/10000/effect_of_medically_tailored_meals_on_clinical.4.aspx

Effect of Medically Tailored Meals on Clinical Outcomes in... The purpose of this study is to evaluate whether medically tailored meals (MTMs) improve outcomes in recently discharged adults with nutrition-sensitive ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06142903

Comparative Effectiveness of 7 Versus 21 Home-delivered ... This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1071916424009588/pdf

Medically Tailored Meals in Heart Failure: A Systematic ... In patients with heart failure, the provision of medically tailored meals (MTMs) may improve clinical outcomes such as heart failure readmission and mortality.