Heart FailureNCT04289181
A Trial to Evaluate Medically Tailored Meals With Patients With Heart Failure
A study testing Medically Tailored Meals in people with Heart Failure, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medically Tailored Meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Medically Tailored Meals
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored MealsOther
4 weeks of medically tailored meals
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment
Feasibility will be measured by the number of patients enrolled in the study. We aim to enroll 30 total patients.
Measured: One year
Feasibility: Retention
Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 4 weeks
Measured: 4 weeks
Feasibility: Retention
Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 12 weeks
Measured: 12 weeks
Secondary outcomes (5)
Patient satisfaction with intervention
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.
Measured: 4 weeks
Feasibility of administering the patient activation measure short form (PAM-13)
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.
Measured: Baseline, 4 weeks, 12 weeks
Feasibility of administering the Dutch Heart Failure Knowledge Scale
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).
Measured: Baseline, 4 weeks, 12 weeks
Feasibility of administering the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
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.
Measured: Baseline, 4 weeks, 12 weeks
Feasibility of administering the Minnesota Living with Heart Failure Questionnaire (MLHF)
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.
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start5 Mar 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AnnaMarie Chang, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289181
- Sponsor's protocol ID
- 19G.837
- Status last verified
- Oct 2021
- First submitted
- 17 Feb 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial Assessing the Feasibility of Providing Medically-tailored Meals to Patients Diagnosed With Heart Failure
- ClinicalTrials.gov ID
- NCT04289181
- Acronym / sponsor ID
- 19G.837
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medically Tailored Meals (MTM) | Experimental | Other: Medically Tailored MealsParticipants 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. |
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically Tailored Meals4 weeks of medically tailored meals | Other | Medically Tailored Meals (MTM) |
Primary outcome
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.
Feasibility: Retention
Time frame: 4 weeks
Feasibility will be measured by the percent of enrolled patients who complete follow-up visits at 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
5 secondary outcomes
Patient satisfaction with intervention
Time frame: 4 weeks
Feasibility of administering the patient activation measure short form (PAM-13)
Time frame: Baseline, 4 weeks, 12 weeks
Feasibility of administering the Dutch Heart Failure Knowledge Scale
Time frame: Baseline, 4 weeks, 12 weeks
Feasibility of administering the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
Time frame: Baseline, 4 weeks, 12 weeks
Feasibility of administering the Minnesota Living with Heart Failure Questionnaire (MLHF)
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored Meals in people with Heart Failure, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Enrollment (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.