The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes.
Cardiac rehabilitation is an evidence-based outpatient program designed to help people recover from heart-related conditions through supervised exercise, education, counseling, and support for healthy lifestyle changes. Although cardiac rehabilitation is highly recommended and beneficial, many patients do not receive the full benefits of the program. Some patients attend fewer sessions than recommended, and many find it difficult to maintain healthy habits outside of the clinic, such as regular physical activity, heart-healthy eating, taking medications as prescribed, monitoring blood pressure, and managing weight.
This study will test whether combining CBCR with mobile health tools may improve participation and support healthy behaviors at home. Mobile health tools include mobile phone applications, connected devices such as a weight scale, blood pressure monitor, and activity tracker, as well as personalized text messages designed to encourage and support healthy self-care.
This study will help determine whether these mobile health tools can make cardiac rehabilitation more effective and help patients maintain healthy behaviors beyond the clinic setting.
Adults aged 18 years or older.
Enrolled in or referred to Phase II Center-based Cardiac Rehabilitation Program.
Acute myocardial infarction
Percutaneous coronary intervention
Not enrolled in or not planning to participate in Phase II Center-based Cardiac Rehabilitation Program.
Presence of a medical, cognitive, psychiatric, or physical condition that, in the opinion of the investigators or CR team, would preclude safe participation in the study or adherence to study procedures.
Severe cognitive impairment or active psychiatric illness that would interfere with informed consent or study participation.
Terminal illness or other serious medical condition that in the judgement of the treating clinician or investigator would likely preclude completion of the study follow-up period. .
Parallel
CBCR
Other interventionThe CBCR program at UI Health is a structured, medically supervised secondary prevention program for patients with qualifying cardiovascular conditions. It includes individualized aerobic and resistance exercise training, clinical monitoring during exercise sessions, education on heart disease and risk factor management, counseling to promote healthy lifestyle behaviors, and support for long-term adherence to prescribed treatment and self-care recommendations. Participants are encouraged to attend up to 36 supervised sessions over \~12 weeks.
BRIDGE mHealth intervention
BehavioralDescription: The intervention includes three commercially available mHealth apps and devices: Withings Body Composition weight scale, Withings BP monitor, and Fitbit Charge 6 activity tracker along with their companion mobile apps. Each app incorporates behavior change tools that support daily self-monitoring, feedback, and reminders across key cardiac rehabilitation domains, including physical activity, weight and blood pressure management, and cardiovascular risk factor reduction. Participants will also receive up to five individually tailored text messages per week throughout the intervention period. Messages will be individualized based on (1) patient responses to validated questionnaires administered at baseline and (2) patient-generated health data from the app/devices. Messages will target physical activity, healthy eating, weight management, blood pressure control, and cardiovascular risk reduction.
Functional capacity as measured by peak metabolic equivalents (METs).
Peak metabolic equivalents (METs) is a valid, clinically meaningful, and widely accepted measure of functional capacity in patients with CVD and in CR settings. It's found that peak functional capacity measured in METs is the strongest predictor of mortality risk in both normal subjects and patients with CVD. Each one MET increase is has been associated with 25% reduction in all-cause mortality among CR patients. Peak METs will be generated by the clinic's telemetry system (cardiline) during graded exercise test (GXT), using workload estimates derived from treadmill speed and grade. Peak METs are routinely used in the CR clinic to guide individualized exercise prescription.
Blood pressure
Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be measured at the clinic and reported in the patient's chart (EMR).
Body Mass Index (BMI)
BMI will be used to measure weight management and body composition.
Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)
Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a reliable and valid measure to screen and measure the level of depression. It has been extensively tested in various populations with excellent psychometric properties (Cronbach's α 0.86-0.89). The total score ranges from 0 to 27, with a higher score indicating a more severe level of depression.
Health related quality of life (HRQoL)
Health related quality of life (HRQoL) will be assessed with the Medical Outcomes 36-Item Short Survey (SF-36). SF-36 has been used extensively in CR studies, and its psychometric properties have been tested among patients with CVD. The 36 items are divided into 8 subscales: Physical Functioning, Roles Limitations due to Physical Problems, General Health Perceptions, Vitality, Social Functioning, Role Limitations due to Emotional Problems, General Mental Health, and Health Transition. Items within each subscale are totaled to yield a summed score for that subscale. Each summed score ranges from 0 (negative health) to 100 (positive health).
Physical activity as measured by the Fitbit-measured step counts
Average number of steps and moderate-to-vigorous physical activity (MVPA) minutes per day will be assessed with Fitbit - a valid wrist- based monitor for patients in the intervention group. All time-stamped activity and wear-time data will automatically be transferred via participants' phone to the iCardia server. Activity Questionnaire short form (IPAQ-SF) for patients in both the intervention group and control group.
Physical activity as measured by the International Physical Activity Questionnaire short form (IPAQ-SF)
Self-reported physical activity will be assessed by the International Physical Activity Questionnaire short form (IPAQ-SF) for patients in both the intervention group and control group. The IPAQ-SF is a 9-item form that records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. The correlation between the IPAQ-SF overall scale and any index never reached the standard of 0.50.
Heart healthy diet adherence as measured by the the 14-item Mediterranean Diet adherence screener (MEDAS)
Mediterranean Diet adherence screener (MEDAS) is a 14-item questionnaire. MEDAS assesses the participants' Mediterranean diet adherence. The Mediterranean diet is a cardioprotective eating pattern that emphasizes whole, minimally processed foods.The Mediterranean diet has been shown to offer significant health benefits for patients with cardiovascular and cerebrovascular conditions, certain cancers, type 2 diabetes, and cognitive decline. It is a valid (ICC =0.692, Pearson r = 0.573) and low-burden instrument suitable for clinical and research use. MEDAS will be used to evaluate and generate TMs targeting nutrition. The overall score of Mediterranean Diet adherence screener (MEDAS) ranges from 0 to 14, with a higher score indicating healthy diet adherence.
Medication adherence as measured by the 12-item Adherence to Refills and Medication Scale (ARMS).
Adherence to Refills and Medication Scale (ARMS) is a 12-item questionnaire. ARMS assesses behaviors related to prescription and medication use. This tool has demonstrated strong reliability (Cronbach's α = 0.814) and validity (Spearman's ρ =-0.651, P \< 0.01), including in populations with limited health literacy. ARMS will be used to evaluate and generate TMs targeting CVD risk management (i.e., medication adherence).
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
