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临床试验/NCT07741396
NCT07741396尚未招募不适用

BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation as a Model for Chronic Disease Management

University of Illinois at Chicago0 个研究点目标入组 30 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Functional capacity as measured by peak metabolic equivalents (METs).

研究概览

简要总结

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.

详细描述

Phase II Cardiac Rehabilitation (CR) is an evidence-based secondary prevention program for patients with cardiovascular disease (CVD).The core components of comprehensive CR are well-established and include patient assessment, exercise training, physical activity (PA) promotion, health education, nutritional counseling, psychological support, and CVD risk management. Phase II CR programs generally offer three sessions per week in an outpatient center - known as center-based CR (CBCR) - and supplemental healthy lifestyle behaviors are encouraged in patients' daily living environments. Despite strong evidence supporting the effectiveness of CBCR, its impact is constrained by four main barriers: 1) patients often fail to maintain adequate physical activity on non-CR days; 2) many patients fail to attend all prescribed CR sessions while others prematurely discontinue the program; 3) many CBCR programs are exercise-centered, offering minimal attention to other core components (e.g. risk management); and 4) reach remains limited, with poor adherence to home-based recommendations. Data shows that up to 86.5% of CR participants fail to meet guideline-recommended weekly PA targets and remain largely inactive on non-CR days. Also, only 26.9% of participants completed the 36-session course of CBCR, while 56.7% attended at least 25 sessions - a threshold associated with significant health benefits. Additionally, standardized educational programs for CR participants are lacking across many healthcare systems, and it is reported that a lack of CR knowledge and low self-efficacy are significant barriers to CR adherence and PA regimen adherence. Many CR programs do not fully deliver all components of comprehensive CR, with a tendency to emphasize exercise training while providing less consistent attention to diet, medication adherence, and other risk management components. Innovative and scalable strategies that extend patient support beyond the clinic and reinforce behavior change are urgently needed to maximize the clinical benefits of CBCR.

Mobile health (mHealth) technologies, such as smartphones, apps, text messages, wearables, and other commercially available connected health devices, have gained popularity in recent years. These mHealth tools offer a promising adjunctive approach to traditional CBCR programs, helping overcome some of the existing challenges. Mobile apps and wearable activity trackers can facilitate more frequent self-monitoring in the community and encourage positive health behaviors, including self-management of CVD. Evidence shows that text messages (TMs) are associated with improvements in PA and medication adherence among different populations and support self-management of chronic conditions. Our recent systematic review published in The Lancet Digital Health demonstrates that provision of exercise-based CR at home facilitated by mHealth technologies is associated with significantly greater benefits in functional capacity and other health outcomes compared with usual care. These findings confirmed that mHealth can effectively enable patients to engage in CR-related behaviors outside formal outpatient settings. However, very few studies have evaluated mHealth as an adjunct to CBCR to extend behavioral support in people's daily living environments. The question of whether mHealth tools can meaningfully augment the effectiveness of CBCR remains largely underexplored. Additionally, prior studies have mainly tested research-developed apps that are not commercially available, thus limiting scalability and potential for real-world implementation. The effect of tailored theory-based TM programs combined with widely used commercial mHealth tools among CBCR participants remains underexplored.

To address these gaps, our study team has developed an mHealth intervention (BRIDGE) that integrates commercially available mHealth apps (Fitbit app and Withings app) and connected devices (Fitbit tracker, Withings BP and weight monitor) with individually tailored TMs selected from a study-developed TM library. BRIDGE intervention will augment CBCR by targeting multiple CR components, including exercise training, PA, heart-healthy diet, weight management, and CVD risk management.

The goal of the proposed project is to evaluate the feasibility, acceptability, and preliminary efficacy of the BRIDGE intervention in improving exercise capacity and self-reported health outcomes through a randomized controlled trial (RCT). A total of 30 CR participants will be recruited and randomized to one of two treatment groups: (1) CBCR alone, (2) CBCR + BRIDGE intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Functional capacity as measured by peak metabolic equivalents (METs).

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

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

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