Enhanced Support for Cardiac Rehabilitation

(SUPeRFOOD Trial)

Overseen By Rae Oanesa, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Enrolled in hospice, unable to consent

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether extra support, such as navigation assistance and text messages, can help individuals adhere to a "Food is Medicine" program during cardiac rehab. Participants will be divided into four groups to test these methods: some will receive navigation help, some will receive text messages, some will receive both, and others will continue with regular care. The researchers aim to determine if these tools increase the number of meals or groceries received after three months. This trial suits those currently participating in cardiac rehab at UCSF and living in San Francisco County. As an unphased trial, it provides a unique opportunity to contribute to innovative approaches in cardiac rehab support.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study focuses on support for cardiac rehabilitation rather than medication changes.

What prior data suggests that these methods are safe for cardiac rehabilitation participants?

Research has shown that using navigation and text messaging for heart rehab is generally safe and well-received by patients. Studies have found that mobile technology, such as text messaging, helps more people adhere to their heart rehab plans, indicating both safety and effectiveness.

For navigation, research suggests that guiding patients through their rehab encourages participation and retention in the program without major safety concerns. This support can lead to better overall outcomes.

Similarly, text messaging programs have improved mental health issues like anxiety and depression in heart patients, indicating these programs are safe.

In summary, both navigation and text messaging interventions appear safe for heart rehab, with no major problems reported in studies. They help patients remain engaged and improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Enhanced Support for Cardiac Rehabilitation because it explores innovative ways to boost recovery after heart issues. Unlike standard cardiac rehab, which typically involves supervised exercise and education, this trial looks at integrating navigation and text messaging to enhance patient support. The navigation approach aims to guide patients through their recovery journey more effectively, while text messaging offers a convenient way to keep patients engaged and motivated. These methods could make cardiac rehabilitation more accessible and personalized, potentially improving outcomes and helping more people stick with their recovery plans.

What evidence suggests that this trial's treatments could be effective for increasing participation in a Food is Medicine program?

This trial will evaluate different strategies to enhance support for cardiac rehabilitation. Participants in one arm will receive navigation support alongside usual care, which studies have shown greatly increases participation in heart health programs. Another arm will combine navigation support with text messaging and usual care. Research indicates that text message reminders encourage patients to stay active and involved, leading to better attendance and improved mood. A separate arm will focus on text messaging with usual care. Together, these strategies aim to boost involvement in important health programs. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals in cardiac rehabilitation. It's designed to see if extra guidance and text message reminders can help them stick with a Food is Medicine program, which provides healthy meals or groceries.

Inclusion Criteria

I can communicate in English or Spanish.

Participating in UCSF Cardiac Rehabilitation

Resident of San Francisco County

Exclusion Criteria

I am unable to give my own consent for medical procedures.

Enrolled in hospice

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to one of four groups: navigation, text-messaging, both, or neither, and receive support accordingly

3 months

Surveys at start and end of 3 months

Follow-up

Participants are monitored for engagement and satisfaction with the Food is Medicine program

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Navigation
• Text Messaging

Trial Overview The study tests the effectiveness of navigation support, text messaging, both, or neither on participation in a nutrition program. Participants are randomly placed into one of four groups and surveyed at the beginning and after three months.

How Is the Trial Designed?

Group I: Text Messaging + Usual Care Experimental Treatment 2 Interventions

Group II: Navigation + Usual Care Experimental Treatment 2 Interventions

Group III: Navigation + Text Messaging + Usual Care Experimental Treatment 3 Interventions

Group IV: Usual Care Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Project Open Hand

Collaborator

Trials

5

Recruited

820+

Published Research Related to This Trial

A systematic review of studies from 2002-2016 found that 79% of the 28 studies showed that mobile health interventions, like text messaging and apps, effectively improve cardiovascular disease (CVD) outcomes.

Personalized messages, higher engagement through two-way communication, and using multiple methods were key factors in the success of these interventions, with text messaging proving to be more effective than smartphone apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Interventions for the Secondary Prevention of Cardiovascular Disease. Park, LG., Beatty, A., Stafford, Z., et al.[2022]

Patients in cardiovascular and pulmonary rehabilitation prefer SMS text messages that use gain-framed purposes and real images over loss-framed messages and cartoon images, indicating that positive and relatable content enhances engagement.

The study, which analyzed preferences from 54 respondents through a discrete choice experiment, suggests that visual messaging interventions could improve patient satisfaction and support lifestyle changes in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Preferences for Lifestyle-Focused Visual Text Messages in Patients With Cardiovascular and Chronic Respiratory Disease: Discrete Choice Experiment. Choi, M., Raeside, R., Hyun, K., et al.[2021]

A machine learning program was developed to triage SMS text message replies in health interventions, achieving high accuracy (AUC 0.86) in identifying which messages required staff review, potentially reducing the workload for health professionals.

Implementing this ML program could enhance the cost-effectiveness and scalability of SMS-based health interventions by decreasing the number of messages needing manual review, thus allowing for broader reach without significantly increasing staffing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Machine Learning Program to Correctly Triage Incoming Text Messaging Replies From a Cardiovascular Text-Based Secondary Prevention Program: Feasibility Study. Lowres, N., Duckworth, A., Redfern, J., et al.[2021]

Text messaging programs can effectively help individuals change health behaviors, leveraging automated and interactive messages to guide users through the behavior change process.

The authors provide a structured guide for developing these programs, emphasizing the importance of formative research, design, pretesting, and revision to ensure the program meets the needs of the target audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Pretesting a Text Messaging Program for Health Behavior Change: Recommended Steps. Abroms, LC., Whittaker, R., Free, C., et al.[2022]

The study analyzed 1550 SMS messages and 4071 participant replies, finding that supportive and informative messages significantly reduced the likelihood of participants prematurely stopping the program, while notification messages increased the chance of stopping.

Machine learning models effectively categorized message intent and participant replies, showing that informative and instructional messages boosted engagement, while motivational messages did not have a significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Analysis Using Machine Learning to Assess Predictors of Engagement With Mobile Health Chronic Disease Prevention Programs: Content Analysis. Klimis, H., Nothman, J., Lu, D., et al.[2022]

This study aims to evaluate the effectiveness of different reminder methods (text messages, reminder calls, or both) in increasing the use of service referrals among 300 participants from community outreach programs.

The research will help determine how mobile phone-based interventions can enhance community engagement and service utilization, potentially guiding future reminder protocols for similar programs across the country.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. Varma, DS., Hart, M., McIntyre, DS., et al.[2020]

The text message intervention in the FAIR trial effectively supported patients with cardiovascular diseases in maintaining physical activity after supervised cardiac rehabilitation, as reported by eight participants who felt it helped them transition to everyday life.

Patients appreciated the structured action plans and ongoing support through text messages, which made them feel monitored and accountable, but they also expressed a desire for more personal interactions in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is like someone holding your hand when you need it - lived experiences of patients with cardiovascular disease participating in a digital health intervention focusing on the maintenance of physical activity after cardiac rehabilitation. Hamborg, TG., Tang, LH., Andersen, RM., et al.[2023]

A study involving 171 patients showed that SMS-based health education messages significantly improved fasting plasma glucose levels and control rates compared to regular education, indicating the effectiveness of this intervention for managing chronic diseases.

The intervention group also demonstrated better self-management behaviors, including increased vegetable and fruit consumption, weight control, and physical activity, highlighting the feasibility of using SMS to promote healthier habits in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial. Wang, X., Liu, D., Du, M., et al.[2020]

The study aims to promote regular daily walking exercise among patients with Chronic Obstructive Pulmonary Disease (COPD) by using a mobile platform that sends SMS messages to guide exercise intensity.

By providing real-time feedback on exercise intensity through SMS, the intervention seeks to enhance patient engagement and adherence to exercise recommendations, potentially improving their overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPD - endurance training via mobile phone. Hung, SH., Tseng, HC., Tsai, WH., et al.[2017]

A randomized controlled trial involving 310 participants will assess the effectiveness of a 6-month text messaging support program for individuals with cardiovascular and respiratory diseases, focusing on improving clinical outcomes like exercise capacity and adherence to rehabilitation.

The study aims to evaluate not only the clinical benefits of the text messaging intervention but also its implementation and scalability, potentially offering a simple and effective strategy to enhance outpatient care for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial. Redfern, J., Hyun, K., Singleton, A., et al.[2020]

A pilot study involving 32 subjects showed that sending daily text message reminders significantly increased moderate physical activity time by an average of 244.7 minutes and reduced sedentary behavior by 77.5 minutes compared to a control group.

The intervention group also experienced improvements in heart rate, blood pressure, and strength parameters, indicating that text message reminders can effectively enhance adherence to physical activity after cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study. Foccardi, G., Vecchiato, M., Neunhaeuserer, D., et al.[2022]

A systematic evaluation of 3121 mobile health apps for cardiac rehabilitation identified nine that met quality standards, with an average quality score of 3.0 out of 5, indicating a generally high quality of available apps.

The top-rated apps, 'My Cardiac Coach' and 'Love My Heart for Women,' scored above 4.0 in quality, functionality, and adherence to American Heart Association guidelines, suggesting they are effective tools for supporting patients in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Structured Review of Commercially Available Cardiac Rehabilitation mHealth Applications Using the Mobile Application Rating Scale. Meddar, JM., Ponnapalli, A., Azhar, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3759655/

Examining the Effect of a Patient Navigation Intervention on ... Outpatient cardiac rehabilitation (OCR) is an evidence-based approach to effectively reduce the burden of CVD and improve quality of life among survivors of a ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1483957

Effect of Patient Navigation on Enrollment in Cardiac ... The objective of this study was to test the hypothesis that a patient navigation (PN) intervention would achieve significantly higher rates of OCR enrollment ...

3. jacc.org jacc.org/doi/10.1016/j.jacasi.2025.08.007

Long-Term Outcomes of Digital Cardiac Rehabilitation Patients with CAD often experience significant improvements during CR, which positively influences their long-term risk factors and lifestyle choices. It ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.020482

Mobile Technology Improves Adherence to Cardiac ... Cardiac rehabilitation (CR) has been found to reduce mortality by up to 34%. However, despite these known benefits, only 14% to 30% of eligible ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399116304839

The effectiveness of patient navigation to improve ... Patient navigation is an effective intervention to increase health screening rates. Both lay and professional patient navigators (eg, nurses) can be effective.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...