Investigating KardioPAC Mobile App to Improve Physical Fitness Among Cardiac Rehabilitation Patients

Quality of Life Clinical Trial

Official title:

Assessing the Ability of KardioPAC, a Digital Tool, to Facilitate Lifestyle Change in Participants Enrolled in a Cardiac Rehabilitation Program

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05643976
• Other study ID #: 805399
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to sustain regular physical activity, improve health-related quality of life, improve resting blood pressure, improve anthropometrics, and improve adherence to prescribed cardiac rehabilitation sessions among individuals referred for cardiac rehabilitation (CR). Numerous studies show that CR improves clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adjunctive intervention, however, remains limited due to poor short- and long-term adherence. This proposed study will examine the effectiveness of the Kura Care KardioPac digital application plus CR to significantly sustain exercise adherence among CR patients, as compared to standard of care alone.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Referred to the University of California San Diego Health Cardiac Rehabilitation Center for 36-72 sessions of intensive cardiac rehabilitation for one of the following medical conditions: myocardial infarction, coronary artery bypass surgery, stable angina, heart valve repair or replacement, coronary angioplasty or stenting, congestive heart failure, heart transplant, or peripheral arterial disease

2. Able to give informed consent in English

3. Able to perform study assessments as described

4. Resting BP<180/110 mmHg

5. Able to perform light to moderate exercise

6. Have not had a fall during the previous 6 months resulting in an injury

7. Clinical staff's permission to participate, including their assessment that participant is a good candidate for this research study

8. Ability to complete written or app-based surveys

9. Owns an Apple or Android mobile telephone capable of downloading and running the app

Exclusion Criteria:

1. Referred to CR following Ventricular Assist Device procedure

2. Angina not adequately managed with nitrates

3. Oxygen-dependent Chronic Obstructive Pulmonary Disease

4. Recent stroke or significant cerebral neurologic impairment that would interfere with participation.

5. Unable to operate a BP device

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Exercise
• Quality of Life

Intervention

Behavioral:
• KardioPAC Mobile Application
Like those in the SOC CR arm, participants assigned to the CR+KardioPAC arm will receive standard of care and attend CR as prescribed by their physician. Additionally, they will receive access to the digital app, KardioPAC, & a BP device for home use that will record their BP readings in the app. KardioPAC is a remote patient monitoring system that allows providers to monitor patients and send out daily reminders. It integrates with BP monitors and fitness watches to collect patient health information at home. The information is uploaded to the HIPAA-compliant server and presented on the website for providers to read. Its reminder system can be customized to meet diverse clinical needs. Lastly, the Kura Care in-house Registered Nurse will provide 20-30 min of health coaching to intervention arm participants on a weekly or bi-weekly basis via the app. The coaching will include greetings, review of medication adherence, encouragement to exercise, and symptom management, if applicable.

Other:
• Standard of Care
During the prescribed cardiac rehabilitation, the SOC CR intervention participants will receive standard of care by attending the 36-72 sessions of CR as prescribed by his/her physician and administered by the University of California San Diego Health Cardiac Rehabilitation Center.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	KURA Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting Blood Pressure	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change resting blood pressure at pre- and post-CR.	~4 Months
Other	Body Composition	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change body composition at pre- and post-CR.	~4 Months
Primary	Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change the activity level of participants.	~4 Months
Secondary	Health-related quality of life as measured by the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®-29)	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change health-related quality of life at pre- and post-CR.	~4 Months