AIRWISE Intervention for Cardiovascular Disease

Overseen By Ethan S Walker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Montana

Disqualifiers: Smoking, HEPA use, Moving, others

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

Compensation: Varies

Number of Visits: 2

20 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. It focuses on improving indoor air quality and does not mention medication changes.

What data supports the effectiveness of the AIRWISE treatment for cardiovascular disease?

Research shows that using wearable devices and mobile apps can help people with cardiovascular disease improve their physical activity, manage risk factors like high blood pressure and cholesterol, and enhance their overall well-being. These tools often include features like tracking healthy behaviors and providing personalized education, which can lead to better health outcomes. ^{1 2 3 4 5}

How is the AIRWISE treatment for cardiovascular disease different from other treatments?

The AIRWISE treatment is unique because it focuses on improving air quality and uses real-time monitoring through wearable devices to track health indicators, which helps in the prevention and management of cardiovascular disease by providing continuous data outside of clinical visits. ^{4 6 7 8 9}

What is the purpose of this trial?

This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among adults 55 years of age or older. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance.

Eligibility Criteria

This trial is for adults over 20 who've had a recent heart procedure called percutaneous coronary intervention at the Providence Heart Institute. They must live in one place most of the week, have electricity, an email address, and internet or cell service to participate in surveys.

Inclusion Criteria

I am 20 years old or older.

I had a heart procedure at Providence Heart Institute.

I live in one place most of the week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the AIRWISE intervention, which includes air filtration, education, and behavioral recommendations

6 months

Electronic surveys every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• AIRWISE

Trial Overview The AIRWISE study tests an indoor air pollution intervention that includes air filtration systems, education, and behavior tips aimed at improving heart patients' health. All participants will try this approach to see if it's accepted and used effectively.

Participant Groups

Group I: Air pollution intervention implementation Experimental Treatment 1 Intervention

AIRWISE intervention implementation

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials

29

Recruited

4,700+

Providence Heart Institute

Collaborator

Trials

1

Recruited

20+

Findings from Research

Wearable physical activity monitoring devices significantly increase daily walking activity in patients with cardiovascular disease (CVD), with a notable effect size of 0.85 based on a systematic review of 16 randomized controlled trials.

The most substantial improvements in daily steps were observed in interventions lasting less than 3 months, suggesting that shorter-term use of these devices may be more effective for enhancing physical activity in CVD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of wearable device-based interventions with feedback for increasing daily walking activity and physical capacities in cardiovascular patients: a systematic review and meta-analysis of randomised controlled trials. Heizmann, AN., Chapelle, C., Laporte, S., et al.[2023]

Mobile applications for cardiovascular disease self-management have shown effectiveness in improving various health outcomes, such as reducing rehospitalization rates and enhancing quality of life among 607 patients across 10 studies.

Key features of successful apps included tracking healthy behaviors and personalized content, but the overall evidence quality was low, highlighting the need for larger, longer-term studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data. Coorey, GM., Neubeck, L., Mulley, J., 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]

Consumer technologies for monitoring cardiovascular health have expanded from exercise tracking to include various physiological measurements, reflecting a growing public interest in their potential to identify and manage cardiovascular diseases.

The review assesses the accuracy and validation of these devices, suggesting that when used correctly, they could enhance healthcare delivery and support research in conditions like hypertension and heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technology and the cardiovascular system: the future of patient assessment. Williams, GJ., Al-Baraikan, A., Rademakers, FE., et al.[2023]

A 6-week pedometer-based telephone intervention significantly increased physical activity levels in 215 cardiac patients who did not attend a cardiac rehabilitation program, with improvements in total activity time and walking sessions observed at both 6 weeks and 6 months.

This intervention could serve as an effective and accessible alternative for enhancing physical activity in cardiac patients post-hospitalization, potentially leading to major health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation. Furber, S., Butler, L., Phongsavan, P., et al.[2022]

In a study of over 214,000 patients, 55.8% reported using a wearable device for health tracking, indicating that these devices are widely adopted among individuals receiving cardiovascular care.

Most non-users (95.3%) expressed willingness to use a wearable device if provided for free, and nearly all respondents (98%) were open to sharing their device data for health research, highlighting a strong interest in integrating wearable technology into healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Attitudes of Wearable Device Users and Non-Users in a Large Healthcare System. Venn, RA., Khurshid, S., Grayson, M., et al.[2023]

An integrative review of 15 articles found that educational technologies, particularly those implemented as year-long programs, significantly improved cardiovascular health outcomes in adults, including reductions in blood pressure and weight.

The most effective programs utilized playful technologies, such as storytelling and smartphone applications, leading to decreased hospitalizations and increased longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educational technologies designed to promote cardiovascular health in adults: integrative review]. Souza, AC., Moreira, TM., Borges, JW.[2019]

Continuous monitoring of health indicators through wearable devices can significantly improve the assessment and management of cardiovascular diseases, which currently claim 18 million lives annually.

The review highlights three key areas for monitoring: physical activity, indoor home environments, and physiological parameters, each offering unique advantages and challenges for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Monitoring of Health and Mobility Indicators in Patients with Cardiovascular Disease: A Review of Recent Technologies. Shiwani, MA., Chico, TJA., Ciravegna, F., et al.[2023]

Smart wearables, like fitness bands and smartwatches, can continuously monitor heart health through photoplethysmography, which measures the arterial pulse wave influenced by cardiovascular function.

The survey highlights the potential of these devices to detect cardiovascular disease early and emphasizes the need for further research to fully harness their capabilities in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Photoplethysmography for Cardiovascular Monitoring. Charlton, PH., Kyriaco, PA., Mant, J., et al.[2023]

References

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

Impact of wearable device-based interventions with feedback for increasing daily walking activity and physical capacities in cardiovascular patients: a systematic review and meta-analysis of randomised controlled trials. [2023]

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

Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Wearable technology and the cardiovascular system: the future of patient assessment. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation. [2022]

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

Characteristics and Attitudes of Wearable Device Users and Non-Users in a Large Healthcare System. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

[Educational technologies designed to promote cardiovascular health in adults: integrative review]. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Monitoring of Health and Mobility Indicators in Patients with Cardiovascular Disease: A Review of Recent Technologies. [2023]

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

Wearable Photoplethysmography for Cardiovascular Monitoring. [2023]