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

Sponsor

University of California, San Diego (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05643976

Collaborator

KURA Care (Other)

Enrollment

Location

Arms

15.4

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rehabilitation Exercise Quality of Life	Behavioral: KardioPAC Mobile Application Other: Standard of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Dec 19, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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)	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.

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)

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

Outcome Measures

Primary Outcome Measures

Number of participants meeting at least 150 min/week of moderate physical activity as measured by 7-day actigraphy [~4 Months]
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change the number of participants meeting at least 150 minutes per week of moderate-intensity aerobic exercise at pre- and post-CR.

Secondary Outcome Measures

Health-related quality of life as measured by the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®-29 ) [~4 Months]
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.

Other Outcome Measures

Resting Blood Pressure [~4 Months]
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change resting blood pressure at pre- and post-CR.
Body Mass Index [~4 Months]
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change body mass index (kg/m^2) at pre- and post-CR.
Cardiac Rehabilitation adherence as measured by percent of prescribed sessions attended [~4 Months]
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change adherence to the prescribed cardiac rehabilitation sessions at pre- and post-CR (~3 months).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Referred to the University of California San Diego Health Cardiac Rehabilitation Center for 36-72 sessions of 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, 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

Exclusion Criteria:

Referred to CR following Ventricular Assist Device procedure or heart or lung transplantation
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92093

Sponsors and Collaborators

University of California, San Diego
KURA Care

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pam Taub, MD, Director of Step Family Foundation Cardiovascular Rehabilitation and Wellness Center Professor of Medicine, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT05643976

Other Study ID Numbers:

805399

First Posted:

Dec 9, 2022

Last Update Posted:

Dec 15, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 15, 2022