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

NCT05643976 | Completed

• 1 other identifier: 805399
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Rehabilitation; Exercise; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Delta change in METs (Metabolic Equivalents of Task), a measure of the amount of oxygen consumed during activity compared to resting oxygen consumption.

  ~4 Months

Other Outcomes (2)

• Resting Blood Pressure

  ~4 Months

• Body Composition

  ~4 Months

Study Arms (2)

Standard-of-care cardiac rehabilitation (SOC CR)

ACTIVE COMPARATOR

Other: Standard of Care

Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)

EXPERIMENTAL

Behavioral: KardioPAC Mobile Application; Other: Standard of Care

Interventions

KardioPAC Mobile Application BEHAVIORAL

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.

Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)

Standard of Care OTHER

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.

Cardiac Rehabilitation + KardioPAC (CR+KardioPAC); Standard-of-care cardiac rehabilitation (SOC CR)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to give informed consent in English
• Able to perform study assessments as described
• Resting BP\<180/110 mmHg
• Able to perform light to moderate exercise
• Have not had a fall during the previous 6 months resulting in an injury
• Clinical staff's permission to participate, including their assessment that participant is a good candidate for this research study
• Ability to complete written or app-based surveys
• Owns an Apple or Android mobile telephone capable of downloading and running the app

You may not qualify if:

• Referred to CR following Ventricular Assist Device procedure
• Angina not adequately managed with nitrates
• Oxygen-dependent Chronic Obstructive Pulmonary Disease
• Recent stroke or significant cerebral neurologic impairment that would interfere with participation.
• Unable to operate a BP device

Sponsors & Collaborators

• University of California, San Diego: lead
• KURA Care: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Step Family Foundation Cardiovascular Rehabilitation and Wellness Center Professor of Medicine

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 9, 2022
• Study Start: January 18, 2023
• Primary Completion: June 21, 2024
• Study Completion: November 30, 2024
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)