A Trial to Evaluate Medically Tailored Meals With Patients With Heart Failure

NCT04289181 | Completed

• 1 other identifier: 19G.837
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to conduct a pilot trial that provides 4 weeks of medically-tailored meals (MTM) to patients with heart failure (HF) via collaboration with the Philadelphia Meals on Wheels chapter to assess the feasibility of such an intervention. Patients will be enrolled during either an inpatient hospitalization or an emergency department (ED) visit, and will be randomized into 1 of 2 arms: 1) MTM or 2) usual care that follows guideline-directed medical therapy (GDMT). Evidence gathered from this study will guide the design of a larger randomized controlled trial to be submitted to the National Institutes of Health (NIH) to evaluate the scalability, sustainability and cost-effectiveness of MTM for improving outcomes for patients with HF.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Feasibility: Enrollment

  Feasibility will be measured by the number of patients enrolled in the study. We aim to enroll 30 total patients.

  One year

• Feasibility: Retention

  Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 4 weeks

  4 weeks

• Feasibility: Retention

  Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 12 weeks

  12 weeks

Secondary Outcomes (5)

• Patient satisfaction with intervention

  4 weeks

• Feasibility of administering the patient activation measure short form (PAM-13)

  Baseline, 4 weeks, 12 weeks

• Feasibility of administering the Dutch Heart Failure Knowledge Scale

  Baseline, 4 weeks, 12 weeks

• Feasibility of administering the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)

  Baseline, 4 weeks, 12 weeks

• Feasibility of administering the Minnesota Living with Heart Failure Questionnaire (MLHF)

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

Medically Tailored Meals (MTM)

EXPERIMENTAL

Participants randomized to the MTM arm will receive MTM for 4 weeks. Meals will be prepared and delivered by Meals on Wheels, a non-profit organization that has been delivering meals to seniors nationwide for decades. Meals on Wheels will deliver 21 complete meals to the patient's home each week. They can accommodate a wide range of patient needs and preferences (e.g., low sodium, gluten-free, no pork products, cultural preferences). Meals on Wheels will contact the patient directly to set up an initial assessment phone call to collect relevant data (e.g., specific patient goals for their HF) and to set up a delivery schedule. Nearing the 4-week mark when meal delivery ends, investigators will check-in with each participant to track progress, assess treatment fidelity and answer any questions. All patients will receive information on community resources (e.g., food pantries, food banks) in the area.

Other: Medically Tailored Meals

Usual Care

NO INTERVENTION

Patients in this arm will receive usual services offered at Jefferson for patients with HF. This includes regular visits with a HF provider (primary care or cardiology), standard nutrition teaching, medication optimization and post discharge support. During routine office visits, providers reinforce messages about self-management and provide lists of local and national resources related to nutrition and HF self-management. These services follow guideline directed medical therapy. All patients will receive information on community resources (e.g., food pantries, food banks) in the area.

Interventions

Medically Tailored Meals OTHER

4 weeks of medically tailored meals

Medically Tailored Meals (MTM)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of acute heart failure (AHF), as determined by the treating physician
• Are 50 years of age or older
• Are a patient in the ED or inpatient at TJUH or Methodist Hospita
• Are able to keep food fresh for a week after delivery (e.g., not homeless)
• Have an address that is within the delivery radius of Meals on Wheels-Philadelphia
• Be able and willing to be available for follow-up contact

You may not qualify if:

• Pregnant, planning to be pregnant, or currently breastfeeding.
• Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition \[TPN\])
• Psychiatric co-morbidity that would preclude study participation
• Non-English speaking
• In police custody or incarcerated
• Currently receiving MTM from Meals on Wheels or another provider

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not feasible to blind participants and clinic staff to assignment post enrollment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Clinical Research Operations

Model Details: Enrolled patients will be randomized to 1 of 2 arms: 1) MTM; or 2) usual care in a 1:1 ratio. A computer-generated list of random numbers will be prepared in advance by the study biostatistician and loaded into a REDCap randomization tool to ensure the research staff are blinded to assignment pre-randomization.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 28, 2020
• Study Start: March 5, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

US (1)