Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes
NCT ID: NCT06999369
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
180 participants
INTERVENTIONAL
2025-02-25
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
Patients in the control arm will be asked to complete a baseline survey questionnaire and a final survey questionnaire 6 months after they enroll. During enrollment or (if not obtained at baseline) up to 1 month after, patients will be asked to provide their baseline BP and weight measurements. Study team members will contact patients at month 3 and 6 to ask how they are doing and get follow up BP and weight measurements.
No interventions assigned to this group
Intervention: MedChefs
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 During enrollment or up to 1 month after, patients will be contacted to provide their baseline BP and weight measurements. Patients will be contacted at month 3 and 6 by the research team to see how they are doing, about their app use, get their BP and weight measurements and will be sent a final survey 6 months after they first log into MedChefs.
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.
MedChefs plus 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. 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 study. During enrollment or up to 1 month after, patients will be asked to provide their baseline BP and weight measurements. At month 3 and 6 the research team will contact the patients to see how they are doing and ask for patients follow up BP and weight measurements. Patients will also be asked to complete a final survey 6 months after they first log into MedChefs.
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.
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 study
Interventions
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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.
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 study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
89 Years
ALL
No
Sponsors
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Sutter Health
OTHER
Responsible Party
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Locations
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2121 N. California Blvd., Suite 310
Walnut Creek, California, United States
Countries
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Other Identifiers
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382101125-0525
Identifier Type: OTHER
Identifier Source: secondary_id
2024.112EXP
Identifier Type: -
Identifier Source: org_study_id