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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Exercise; Cardiac Rehabilitation
• Intervention / Treatment: Other: Standard of Care; Behavioral: KardioPAC Mobile Application

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard-of-care cardiac rehabilitation (SOC CR)	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.
Experimental: Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta change in METs (Metabolic Equivalents of Task), a measure of the amount of oxygen consumed during activity compared to resting oxygen consumption.	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to improve functional capacity (METs) at pre- and post-CR.	~4 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: KURA Care

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Motor Activity; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 805399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No