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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nutrition-focused digital tool called the MedChef App for people with heart failure. The goal is to determine if the app, which provides nutrition guidance, can improve health outcomes such as blood pressure and weight. Participants will be divided into groups to use the app, with some also receiving a monthly food voucher to purchase recommended groceries. Ideal candidates have been diagnosed with heart failure since January 2023, have had a recent hospital stay, and are treated in specific California regions. As an unphased trial, this study offers a unique opportunity for patients to explore innovative nutritional support for heart failure management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the MedChef App and food voucher are safe for heart failure patients?

Research has shown that the MedChef app, designed to help manage heart failure, is generally safe and well-received by patients. In studies, patients expressed satisfaction with the app, which assisted them in managing their heart failure symptoms. These studies found that apps for heart failure can enhance quality of life and reduce hospital visits, indicating that the app is effective for managing heart failure.

When combined with Instacart food vouchers, research highlights that access to healthy foods can improve life quality and health outcomes for those with heart failure. These findings suggest that using food vouchers to encourage healthy eating is a safe and beneficial approach for patients.

Overall, both the MedChef app and its combination with food vouchers appear safe for heart failure patients, helping them manage their condition more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for heart failure because they integrate digital tools to promote better nutrition and lifestyle habits. The MedChefs app offers personalized meal recommendations, which is a unique approach compared to traditional treatments that mainly focus on medications and lifestyle advice without digital support. Additionally, the MedChefs plus Instacart Food Voucher arm provides a monthly $100 voucher for purchasing nutritious foods, making it easier for patients to follow the app's recommendations. This combination of technology and practical support has the potential to improve patient engagement and adherence to healthy eating, which could lead to better management of heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that mobile health apps like MedChef, which participants in this trial may use, can reduce hospital visits for heart failure patients by about 23%. These apps also help patients manage their condition and learn more about heart failure care. In this trial, some participants will use the MedChef app alone, while others will use it with vouchers for healthy food. Evidence suggests that access to nutritious foods can further enhance the quality of life for heart failure patients. Studies have found a link between access to healthy food and better health outcomes after a hospital stay for heart failure. Overall, both the app and the food vouchers show promise in effectively managing heart failure. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9845822/

Effectiveness of mobile telemonitoring applications in heart ... We observed a reduced risk of hospitalization due to HF with the use of mobile-based telemonitoring strategies (RR 0.77 [0.67; 0.89]; I2 7%).

2. mhealth.jmir.org mhealth.jmir.org/2021/12/e26185

The Effects of the ManageHF4Life Mobile App on Patients ... The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8693200/

The Effects of the ManageHF4Life Mobile App on Patients ... Secondary outcomes were the change in self-management and HF readmission over time. Self-management was measured using the Self-Care Heart Failure Index (SCHFI) ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030956

Digital Health Interventions for Heart Failure Management ... The studies reported improvement in self‐care behaviors in 4 trials, increased knowledge in 2, and decreased cardiovascular mortality in 1 study ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505623002241

Effect and usability of mobile health applications for ... The included studies indicate a possible outcome in favor of the use of apps to improve medication adherence in HF patients, but with very low quality level of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10466157/

Patients' Experiences Using a Mobile Health App for Self ... Patient satisfaction, measured with a 5-point Likert scale, and an open-ended survey were used to gather data from 23 patients with HF who were ...

7. bmcdigitalhealth.biomedcentral.com bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00126-4

Patients' experience using an app for home remote monitoring ... This study evaluates heart failure patients' experience of the effects of remote monitoring on the management of heart failure (HF) using a smartphone app.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589750024001584

Series Digital tools in heart failure: addressing unmet needs Self-management trials in heart failure have shown improved quality of life and reduced risk of heart failure hospitalisations, and self-management is strongly ...

9. mhealth.jmir.org mhealth.jmir.org/2021/11/e30674

Analysis of Apps With a Medication List Functionality for Older ... Analysis of Apps With a Medication List Functionality for Older Adults With Heart Failure Using the Mobile App Rating Scale and the IMS ...

10. medstarhealth.org medstarhealth.org/blog/heart-failure-app-study

Can an App Save Lives by Improving Treatment for Heart ... A new heart failure app has the potential to help save lives through medication optimization. Learn how AIMs reduce barriers to care and ...