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

84 Participants Needed

Trial Summary

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 data supports the idea that Enhanced Support for Cardiac Rehabilitation is an effective treatment?

The available research shows that Enhanced Support for Cardiac Rehabilitation, which includes text messaging and mobile applications, is effective in improving outcomes for people with cardiovascular disease. For example, a large majority of studies (79%) found that these interventions helped improve health results. One study highlighted that sending daily text message reminders after cardiac rehabilitation led to increased physical activity and reduced sedentary behavior. Participants who received these messages showed improvements in heart rate, blood pressure, and physical strength compared to those who did not. Additionally, text messaging was found to be more effective than smartphone apps in promoting healthy lifestyle changes. Overall, these interventions help patients maintain healthy habits and improve their health after cardiac rehabilitation. ^{1 2 3 4 5}

What safety data is available for mobile health messaging in cardiac rehabilitation?

The research indicates that mobile phone-based text messaging interventions, including SMS, have been widely used in clinical settings for cardiovascular disease management and have shown effectiveness in improving health outcomes. Importantly, there have been no reports of adverse events related to text messaging, such as misreading or misinterpreting data, privacy issues, or message delivery failures. However, there is a noted need for personalized messages to enhance effectiveness. ^{1 3 6 7 8}

Is text messaging a promising treatment for cardiac rehabilitation?

Yes, text messaging is a promising treatment for cardiac rehabilitation. It helps people make healthy lifestyle changes, like reducing heart disease risk, losing weight, exercising more, and quitting smoking. As more people use mobile phones, text messaging can reach a lot of people and keep them engaged in their health. ^{3 9 10 11 12}

What is the purpose of this trial?

The purpose of this research is to see if offering more navigation and text-message support will help increase participation and engagement in a Food is Medicine program. The study will recruit people currently participating in cardiac rehabilitation. People will be randomly assigned to 1 of 4 study groups: navigation, text-messaging, both, or neither. People will complete surveys at the start of the study and after 3 months. After 3 months, we will compare how many Food is Medicine meals or groceries people in each group received.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mobile Phone Interventions for the Secondary Prevention of Cardiovascular Disease. [2022]

2. England 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. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Understanding Preferences for Lifestyle-Focused Visual Text Messages in Patients With Cardiovascular and Chronic Respiratory Disease: Discrete Choice Experiment. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Structured Review of Commercially Available Cardiac Rehabilitation mHealth Applications Using the Mobile Application Rating Scale. [2023]

6. Canada 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. [2021]

7. Canada 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. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Developing and Pretesting a Text Messaging Program for Health Behavior Change: Recommended Steps. [2022]

9. England 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. [2020]

10. Canada 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

COPD - endurance training via mobile phone. [2017]

12. England pubmed.ncbi.nlm.nih.gov

ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial. [2020]