Nutrition Digital Tool for Heart Failure

(HF-FIT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sutter Health

Disqualifiers: Cognitive disabilities, End stage renal, Metastatic cancer, Active substance use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for heart failure patients aged 18-89, who've been hospitalized within the last year and seen a primary care physician or cardiologist. Participants must be from specific areas in the Greater East Bay or Silicon Valley and diagnosed with heart failure after January 1, 2023. Those with cognitive disabilities, active substance abuse, or severe kidney/cancer conditions cannot join.

Inclusion Criteria

Recent hospital admission within a year

All race/ethnic groups

Treated in the Greater East Bay division and Greater Silicon Valley division areas

Exclusion Criteria

History of cognitive disabilities

Active drug/substance use

My condition is end-stage kidney disease or cancer that has spread.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants provide baseline BP and weight measurements and complete a baseline survey

1 month

Intervention

Participants use the MedChefs app and, if applicable, receive monthly food vouchers

6 months

Contact at month 3 and 6 for follow-up measurements

Follow-up

Participants complete a final survey and provide follow-up BP and weight measurements

6 months

Treatment Details

Interventions

• MedChef App
• MedChefs and Instacart food voucher

Trial Overview The trial tests a digital nutrition tool called MedChef App alongside food vouchers to see if they improve health outcomes in heart failure patients. It's about whether using this app and getting certain foods can help manage heart failure better.

Participant Groups

Group I: MedChefs plus Instacart Food Voucher Experimental Treatment 2 Interventions

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.

Group II: Intervention: MedChefs Experimental Treatment 1 Intervention

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.

Group III: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Sutter Health

Lead Sponsor

Trials

26

Recruited

68,900+