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

October 4, 2021 updated by: AnnaMarie Chang, Thomas Jefferson University

A Pilot Trial Assessing the Feasibility of Providing Medically-tailored Meals to Patients Diagnosed With Heart Failure

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

While medication adherence and transitions from hospitalization to home care play important roles in heart failure (HF) care, the majority of HF maintenance is by the patients in the home. Despite the availability of evidence-based guidance and treatments, many patients with HF do not achieve optimal outcomes. In prior work, patients with HF identified primary needs of improved access to food and nutrition education. Dietary recommendations for HF in clinical practice have historically emphasized the reduction of a single micronutrient (sodium) and fluid management, which oversimplifies the complexity between multiple dietary inadequacies, including micronutrient deficiencies, and HF pathophysiology. In addition, patients may have other comorbidities thus requiring further modification of the patient's diet. As a result, several innovative models for food services have emerged to address patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S. deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that food can be as helpful as medicine in improving patient outcomes. Small studies assessing MTM in isolation have demonstrated reduced healthcare utilization and cost, however, no randomized trials have assessed the sustained impact of this intervention. The goal is to evaluate the feasibility of providing medically-tailored meals to patients with HF. Data from this study can be used to design further studies testing the effectiveness of MTM on improving outcomes for patients with HF.

Meals on Wheels, a provider of meals to senior citizens across the country, has only recently begun piloting medically-tailored meals, and this presents the opportunity to work with the organization to test the feasibility of MTM in the Philadelphia region.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medically Tailored Meals (MTM)
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
4 weeks of medically tailored meals
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility: Enrollment
Time Frame: One year
Feasibility will be measured by the number of patients enrolled in the study. We aim to enroll 30 total patients.
One year
Feasibility: Retention
Time Frame: 4 weeks
Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 4 weeks
4 weeks
Feasibility: Retention
Time Frame: 12 weeks
Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction with intervention
Time Frame: 4 weeks
Satisfaction will be measured using a series of satisfaction related questions to better understand patients' experience with receiving medically tailored meals. Likert scale questions will be asked upon the completion of the meal deliveries at the 4 week follow-up assessment. Questions will assess the convenience, taste, and size of received meals.
4 weeks
Feasibility of administering the patient activation measure short form (PAM-13)
Time Frame: Baseline, 4 weeks, 12 weeks
The PAM-13 is composed of 13 items measuring patients' self-reported knowledge, motivation, and skills for health management. Each item is measured on a 5-point likert scale from disagree strongly to agree strongly. Those who score lower on the scale have lower self-management skills, while those who score higher on the scale are more engaged in their self-management.
Baseline, 4 weeks, 12 weeks
Feasibility of administering the Dutch Heart Failure Knowledge Scale
Time Frame: Baseline, 4 weeks, 12 weeks
The Dutch Heart Failure Knowledge Scale consists of 15 multiple choice questions assessing knowledge about Heart Failure in general (4 items), treatment (6 items), and symptoms and symptom recognition (5 items). Patients are instructed to choose the correct response from the three choices provided. The assessment is scored from 0 (no knowledge) to 15 (optimal knowledge).
Baseline, 4 weeks, 12 weeks
Feasibility of administering the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
Time Frame: Baseline, 4 weeks, 12 weeks
The KCCQ-12, a self-administered 12-item instrument, assesses physical limitations, symptoms, self-efficacy, social interference, and overall quality of life (QoL) in HF patients. Higher scores on the KCCQ-12 indicate better QoL. The KCCQ summary score independently predicts clinical outcomes such as hospitalization and mortality in outpatients with HF, including those recently hospitalized for acute decompensation. It is a reliable and valid measure in HF patients that is more sensitive to change than other measures of QoL, and is especially responsive in patients with multiple comorbidities. A change in KCCQ score of 5 points is clinically significant and correlates with changes in clinical status, physical function, and outcomes.
Baseline, 4 weeks, 12 weeks
Feasibility of administering the Minnesota Living with Heart Failure Questionnaire (MLHF)
Time Frame: Baseline, 4 weeks, 12 weeks
The MLHF measures the effects of heart failure and treatments for heart failure on an individual's quality of life. The questionnaire includes 21 items scored on a 6-point likert scale from zero (no impact) to five (big impact). All questions ask the patient to identify how much HF has affected their life during the past month. The survey is scored by adding all 21 responses for a total score. A physical dimension score (8 items) and emotional dimension score (5 items) can also be derived by adding the scores for specific items.
Baseline, 4 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19G.837

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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