BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation

NCT07741396 | Not Yet Recruiting

• 1 other identifier: STUDY2025-0931
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Myocardial Infarction (AMI); Percutaneous Coronary Intervention (PCI); Heart Valve Repair or Replacement; Stable Angina Pectoris; Coronary Artery Bypass Graft Surgery (CABG); Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

cardiac rehabilitation; mHealth; digital tool; consumer-grade technology

Outcome Measures

Primary Outcomes (1)

• 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.

  * Baseline; * End of the CBCR program, an average of 12 weeks

Secondary Outcomes (5)

• Blood pressure

  * Baseline; * End of the CBCR program, an average of 12 weeks

• Body Mass Index (BMI)

  * Baseline; * End of the CBCR program, an average of 12 weeks

• Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)

  * Baseline; * End of the CBCR program, an average of 12 weeks

• Health related quality of life (HRQoL)

  * Baseline; * End of the CBCR program, an average of 12 weeks

• CR completion rate

  * End of the CBCR program, an average of 12 weeks

Other Outcomes (8)

• Physical activity as measured by the Fitbit-measured step counts

  From date of randomization until the end of the CBCR program, an average duration of 12 weeks

• Physical activity as measured by the International Physical Activity Questionnaire short form (IPAQ-SF)

  * Baseline; * End of the CBCR program, an average of 12 weeks

• Heart healthy diet adherence as measured by the the 14-item Mediterranean Diet adherence screener (MEDAS)

  * Baseline; * End of the CBCR program, an average of 12 weeks

Study Arms (2)

CBCR only

ACTIVE COMPARATOR

Participants randomized to the control group will receive standard outpatient CBCR at UI Health with no additional study-delivered mHealth intervention. The 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. In addition to supervised exercise, CBCR includes education related to cardiovascular disease self-management, physical activity, healthy eating, weight management, lipid control, blood pressure management, smoking cessation, stress reduction, and other risk factor modification strtegies.

Other: CBCR

CBCR + BRIDGE

EXPERIMENTAL

Participants randomized to the intervention group will receive BRIDGE in addition to the standard CBCR program at UI Health. BRIDGE is a multimodal mHealth intervention designed to extend behavioral support beyond clinic visits through mobile app- and device-based self-monitoring, feedback, and individually tailored text messages promoting healthy lifestyle behaviors (e.g. physical activity, heart healthy diet, and medication adherence).

Other: CBCR; Behavioral: BRIDGE mHealth intervention

Interventions

CBCR OTHER

The 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.

Also known as: Comprehensive CBCR

CBCR + BRIDGE; CBCR only

BRIDGE mHealth intervention BEHAVIORAL

Description: 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.

CBCR + BRIDGE

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older.
• Enrolled in or referred to Phase II Center-based Cardiac Rehabilitation Program.
• Have a qualifying cardiovascular diagnosis or event that meets standard eligibility for Phase II Center-based Cardiac Rehabilitation, such as:
• Acute myocardial infarction
• Percutaneous coronary intervention
• Coronary artery bypass graft surgery
• Chronic heart failure with reduced ejection fraction
• Heart valve repair or replacement
• Stable angina
• Able to ambulate and participate in exercise testing and training as required by the CR program
• Ability to speak and read in English
• Willing and able to provide informed consent.
• Willing to use study-related devices/apps and complete study assessments.

You may not qualify if:

• 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. .
• Current hospice enrollment or residence in a long-term care facility that would preclude participation in the intervention or completion of study follow-up procedures.
• Currently participating in another behavioral or digital health intervention trial that could confound study outcomes.
• Inability or unwillingness to use the required mobile devices, applications, or monitoring equipment, if applicable.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Spyros Kitsiou, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Li, MSN, RN

CONTACT

13123553519; yli351@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share