Assessing the Ability of KardioPAC, a Digital Tool, to Facilitate Lifestyle Change in Participants Enrolled in a Cardiac Rehabilitation Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Pam Taub, MD
Director of Step Family Foundation Cardiovascular Rehabilitation and Wellness Center Professor of Medicine
University of California, San Diego