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Enrolling by invitation NCT06999369

Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes

No phase Interventional Heart Failure

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MedChef App, MedChefs and Instacart food voucher.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Heart Failure Food Intervention Trial (HF-FIT): Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes

Overview

Measuring the impact of a guideline-based nutrition digital tool in heart failure patients

Detailed description

The goal of this research clinical trial is to learn understand or learn whether a guideline-based nutrition application (app) called MedChefs can help heart failure patients adopt and sustain an evidence-based dietary patterns.

Interventions

  • Other MedChef App
    Once patients have been randomized to the MedChefs arm, they will be contacted by the research team and sent an email link to use the MedChefs app. The research team will contact the patient based on their preferred contact method and will walk through how to use the app and share education on its use.
  • Other MedChefs and Instacart food voucher
    Once patients have been randomized to the MedChefs arm and voucher arm, they will be contacted by the research team and sent an email link to use the MedChefs app. The research team will contact the patient based on their preferred contact method and will walk through how to use the app and share education on its use and use of Instacart food vouchers. Patients will also be given a $100 voucher to buy food recommended by the app. Vouchers will be provided once a month for the 6 months of the stu

Primary outcome measures

  • Blood Pressure [Time frame: Baseline and 6 months]
Secondary outcome measures (1)
  • Weight [Time frame: Baseline and 6 months]

Eligibility criteria

Inclusion criteria

  • 18-89 years old at time of enrollment
  • Any type of Heart failure diagnosis (e.g., I50.x) between 1/1/2023-present
  • Recent hospital admission (within a year)
  • Race/ethnicity: All race/ethnic groups
  • Location: patients have been treated in the Greater East Bay division and Greater Silicon Valley division areas.
  • Patients with have at least 1 office/outpatient visit with a primary care physician or cardiologist visit before index date

Exclusion criteria

  • • Patients with certain patient history (cognitive disabilities) and end stage renal or metastatic cancer diagnosis
  • Patients with active drug/substance use. Patients with heart failure who have active substance use are excluded from the study. HF patients with substance use require additional monitoring and follow up due to potential severe withdrawal symptoms, acute HF exacerbation and drug overdose or medication errors. Standard protocol includes additional monitor vital signs (e.g., blood pressure, heart rate) and HF symptoms (e.g., edema, dyspnea), and performing regular laboratory tests (e.g., renal function, electrolytes) which is beyond the clinical and logistical capabilities of this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • 2121 N. California Blvd., Suite 310 — Walnut Creek

Identifiers

NCT: NCT06999369 · 2024.112EXP · 382101125-0525

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗