mHealth Intervention for Cardiac Rehabilitation

Overseen By Leana Goncalves Araujo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth University

Disqualifiers: Pregnant, Surgery, Other programs, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment mHealth Intervention for Cardiac Rehabilitation?

Research shows that using digital health interventions, like mobile health (mHealth) and activity trackers, can improve access to cardiac rehabilitation and help tailor recovery programs to individual needs. While some studies did not find significant improvements in physical activity levels at 6 months, there were positive changes in exercise intensity and blood pressure in certain groups, suggesting potential benefits of combining technology with traditional rehabilitation. ^{1 2 3 4 5}

Is mHealth intervention for cardiac rehabilitation safe for humans?

The research on mHealth interventions, including digital health and activity-monitoring devices, suggests they are generally safe for use in cardiac rehabilitation. These technologies are designed to support heart health and improve patient outcomes without significant safety concerns. ^{1 4 6 7 8}

How is the mHealth treatment for cardiac rehabilitation different from other treatments?

The mHealth treatment for cardiac rehabilitation is unique because it uses mobile technology to deliver health interventions, making it more accessible and convenient compared to traditional in-person programs. This approach can help overcome barriers like distance and time, allowing patients to engage in rehabilitation activities from home and potentially improving participation and long-term health outcomes. ^{6 7 9 10 11}

What is the purpose of this trial?

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project: 1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA. 2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Eligibility Criteria

This trial is for adults over 18 who are in Phase III Cardiac Rehabilitation (CR) at Hope Clinic. Participants must be able to walk, follow instructions, wear a Fitbit, and use a smartphone with text messaging. They should not be overly active or have upcoming surgery/travel plans within 8 weeks, nor should they be pregnant/lactating or involved in other health programs.

Inclusion Criteria

I am willing to get texts and calls from the research team.

Clients currently receiving Phase III CR at Hope Clinic

I can walk following instructions.

Exclusion Criteria

Clients who are pregnant or lactating

I do not have any surgeries or travel planned in the next 8 weeks.

Clients currently participating in other health promotion program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants use an activity tracker (i.e., Fitbit) to monitor daily steps and sleep patterns

8 weeks

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Mhealth

Trial Overview The study tests an mHealth intervention using activity trackers like Fitbit to monitor physical activity and sleep patterns of Phase III CR clients for 8 weeks. It aims to develop a protocol for self-monitoring and assess the impact on exercise habits, sleep quality, functional capacity, and overall life quality.

Participant Groups

Group I: Hope Clinic Experimental Treatment 2 Interventions

Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission.

Mhealth is already approved in United States, European Union for the following indications:

Approved in United States as MHealth Intervention for:

• Promoting Physical Activity in Cardiac Rehabilitation

Approved in European Union as MHealth Intervention for:

• Supporting Cardiac Rehabilitation through Physical Activity Monitoring

Who Is Running the Clinical Trial?

AdventHealth University

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

A digital health intervention (DHI) combined with remote cardiac rehabilitation (CR) significantly improved access to CR, with 90% of participants completing the program out of 258 who consented from 1,643 referrals.

Participants in the DHI showed notable improvements in their 6-minute walk test distance and reductions in low-density lipoprotein cholesterol, along with a decrease in smoking rates, all without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. Harzand, A., Alrohaibani, A., Idris, MY., et al.[2023]

In a study involving 220 low and moderate risk patients undergoing cardiac rehabilitation, a mobile health (mHealth) intervention did not significantly improve physical activity levels, as measured by the 6-minute walk distance, after 6 months compared to usual care.

While the mHealth intervention showed no overall benefit at 6 months, there were some indications of improved outcomes at 3 months for certain users, particularly those using Fitbit devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a mobile health intervention to augment cardiac rehabilitation. Golbus, JR., Gupta, K., Stevens, R., et al.[2023]

The study will evaluate the effectiveness of a mobile health augmented cardiac rehabilitation program (MCard) over 23-24 weeks for improving health-related quality of life (HRQoL) and clinical outcomes in 160 post-acute coronary syndrome (ACS) patients.

If successful, MCard could provide a cost-effective and resource-efficient rehabilitation option that can be scaled to other cardiac centers, especially important during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Augmented Cardiac Rehabilitation (MCard) in Post-Acute Coronary Syndrome Patients: A randomised controlled trial protocol. Hisam, A., Haq, ZU., Khan, Z., et al.[2022]

This review aims to evaluate how effective activity-monitoring devices and mobile applications are in improving physical activity and health outcomes for patients with cardiovascular disease undergoing cardiac rehabilitation, highlighting their potential role in supporting long-term exercise habits.

The review will analyze systematic reviews and meta-analyses of randomized controlled trials, ensuring a comprehensive assessment of the impact of these technologies on patient outcomes, with a focus on varying effectiveness based on patient characteristics and rehabilitation stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. Dafny, HA., Champion, S., Gebremichael, LG., et al.[2023]

A study involving post-myocardial infarction patients using wearable activity monitors linked to a customized app showed a significant reduction in systolic blood pressure compared to a control group, indicating potential cardiovascular benefits from this technology-enhanced rehabilitation approach.

While both groups reported similar changes in physical activity levels by the end of the cardiac rehabilitation program, the digitally monitored group demonstrated a trend towards achieving higher exercise intensity (measured in METS) at 12 weeks, suggesting that technology may help enhance engagement in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitally enabled cardiac rehabilitation following coronary revascularization: results from a single centre feasibility study. Hatch, V., Davies, WR.[2022]

A survey of 74 adults with cardiovascular disease showed that 95% owned mobile phones and 77% were interested in receiving cardiac rehabilitation information via text messages, indicating a strong potential for mobile technology to enhance CR attendance.

A pilot study with 20 participants revealed that a 4-week healthy eating program delivered through mobile technology significantly improved self-efficacy related to heart-healthy eating, particularly in environmental self-efficacy, suggesting that text messaging is an effective method for delivering nutrition information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Self-Management: Pilot Testing of an mHealth Healthy Eating Program. Dale, LP., Whittaker, R., Eyles, H., et al.[2022]

Cardiac rehabilitation is highly beneficial for various cardiovascular conditions but is often underutilized, indicating a need for improved patient engagement and support.

Digital technology can enhance traditional cardiac rehabilitation by providing flexible, accessible interventions that improve health outcomes and promote health equity, as outlined in this American Heart Association advisory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. Golbus, JR., Lopez-Jimenez, F., Barac, A., et al.[2023]

The mHealth program 'Text4Heart' significantly improved adherence to healthy lifestyle behaviors in adults with coronary heart disease (CHD) at 3 months compared to usual care, indicating its potential effectiveness as a complementary intervention.

While the intervention showed a positive impact on medication adherence and lifestyle changes initially, these effects were not sustained at the 6-month follow-up, suggesting the need for further research to evaluate long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial. Pfaeffli Dale, L., Whittaker, R., Jiang, Y., et al.[2023]

In a study involving 1025 patients from a cardiac rehabilitation program, only 12% preferred to replace some in-person sessions with smartphone-based health interventions (mHealth), indicating limited interest in mHealth during the initial rehabilitation phase.

However, nearly 48% of patients expressed interest in using mHealth for continued exercise training after completing their rehabilitation, suggesting a potential for mHealth in long-term patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient interest in mHealth as part of cardiac rehabilitation in Switzerland. Marcin, T., Bengel, C., Goldberg, T., et al.[2021]

A randomized controlled trial involving 170 adults with cardiovascular disease is testing a mobile phone-delivered exercise-based cardiac rehabilitation program to improve exercise capacity and functional outcomes compared to usual care.

The trial aims to assess not only the effectiveness of the mHealth program in increasing exercise behavior over six months but also its impact on cardiovascular risk factors and overall quality of life, potentially offering a scalable solution for cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HEART: heart exercise and remote technologies: a randomized controlled trial study protocol. Maddison, R., Whittaker, R., Stewart, R., et al.[2021]

The VALENTINE Study is a randomized-controlled trial evaluating the effectiveness of a mobile health (mHealth) intervention to enhance physical activity in low- and moderate-risk cardiovascular patients, using smartwatches and tailored notifications to encourage exercise.

The primary outcome of the study is the change in 6-minute walk distance after 6 months, with secondary outcomes including daily step count, aiming to understand how mHealth technologies can sustain activity levels post-cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. Jeganathan, VS., Golbus, JR., Gupta, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A randomized trial of a mobile health intervention to augment cardiac rehabilitation. [2023]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Mobile Health Augmented Cardiac Rehabilitation (MCard) in Post-Acute Coronary Syndrome Patients: A randomised controlled trial protocol. [2022]

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

Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Digitally enabled cardiac rehabilitation following coronary revascularization: results from a single centre feasibility study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Self-Management: Pilot Testing of an mHealth Healthy Eating Program. [2022]

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

Digital Technologies in Cardiac Rehabilitation: A Science Advisory From the American Heart Association. [2023]

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

Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Patient interest in mHealth as part of cardiac rehabilitation in Switzerland. [2021]

10. England pubmed.ncbi.nlm.nih.gov

HEART: heart exercise and remote technologies: a randomized controlled trial study protocol. [2021]

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

Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. [2022]