Cardiac RehabilitationNCT05643976
Investigating KardioPAC Mobile App to Improve Physical Fitness Among Cardiac Rehabilitation Patients
A study testing KardioPAC Mobile Application in people with Cardiac Rehabilitation and Exercise, run by University of California, San Diego at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Rehabilitation, Exercise, Quality of Life
- What is being tested?
- KardioPAC Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: 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.
- Conditions
- Cardiac Rehabilitation, Exercise, Quality of Life
- Being tested
- KardioPAC Mobile Application, Standard of Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KardioPAC Mobile ApplicationBehavioural
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care cardiac rehabilitation (SOC CR) | Active comparator | Not described Receives: Other: Standard of Care |
| Cardiac Rehabilitation + KardioPAC (CR+KardioPAC) | Experimental | Not described Receives: Behavioral: KardioPAC Mobile Application; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~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.
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to improve functional capacity (METs) at pre- and post-CR.
Measured: ~4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start18 Jan 2023
- Primary completion21 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- KURA Care
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643976
- Sponsor's protocol ID
- 805399
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2022
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Ability of KardioPAC, a Digital Tool, to Facilitate Lifestyle Change in Participants Enrolled in a Cardiac Rehabilitation Program
- ClinicalTrials.gov ID
- NCT05643976
- Acronym / sponsor ID
- 805399
- Conditions
- Cardiac Rehabilitation, Exercise, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- KURA Care
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KardioPAC Mobile ApplicationLike 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. | Behavioural | Cardiac Rehabilitation + KardioPAC (CR+KardioPAC) |
| Standard of CareDuring 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. | Other | Cardiac Rehabilitation + KardioPAC (CR+KardioPAC), Standard-of-care cardiac rehabilitation (SOC CR) |
Primary outcome
Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.
Time frame: ~4 Months
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change the activity level of participants.
1 secondary outcome
Delta change in METs (Metabolic Equivalents of Task), a measure of the amount of oxygen consumed during activity compared to resting oxygen consumption.
Time frame: ~4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KardioPAC Mobile Application in people with Cardiac Rehabilitation and Exercise, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy. (time frame: ~4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.