scholarly journals Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Richard Y. Cao ◽  
Hongchao Zheng ◽  
Qiongyao Mi ◽  
Qing Li ◽  
Wenchao Yuan ◽  
...  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jing Jing Su ◽  
Doris Sau Fung Yu

Abstract Background Cardiac rehabilitation (CR) uptake and adherence remain sub-optimal despite the apparent health benefits of modifying healthy behavior and slowing disease progression. eHealth is the use of information and communication technology (ICT) for health. eHealth lifestyle interventions and disease management have emerged as modalities to enhance CR accessibility, enable an individualized progress page, and enrich real-time contact, video-based information, and technology monitored functionality. This study aims to develop a nurse-led eHealth cardiac rehabilitation (NeCR) intervention and investigate its effectiveness on coronary heart disease (CHD) patients’ health outcomes. Methods This single-blinded two-arm parallel randomized controlled trial will randomize 146 patients from the inpatient cardiovascular units of a hospital in Wuhan, China to receive either the NeCR or the usual care. The NeCR intervention uses a hybrid approach consisting of a brief face-to-face preparatory phase and an empowerment phase delivered by health technology. The preparatory phase aims at identifying self-care needs, developing a goal-oriented patient centered action plan, incorporating a peer support network and orientation to the use of the e-platform. The empowerment phase includes use of the multi-media interactive NeCR for promoting symptom management, monitoring lifestyle changes and offering psychological support. A tele-care platform is also integrated to enhance health care dialogue with health professionals and peer groups. The control group will receive the usual care. An evaluation of lifestyle behavioral changes, self-efficacy, health-related quality of life, anxiety and depression, cardiovascular risk parameters, and unplanned health services use will be conducted at baseline, 6 weeks and 12 weeks post-intervention. Discussion This protocol proposes an individualized, comprehensive, and interactive NeCR delivered using a hybrid approach and guided by an empowerment model to optimize health outcomes of CHD patients. The intervention content and web-design is based on international health guidelines to improve credibility, comprehensibility and implementation. This study also proposes a new method of peer support in which the researcher shares participants’ progress toward goal attainment with the peer group. Results of this research have the potential to increase accessibility and availability of CR, improve cardiac rehabilitation service development in China, and inform eHealth lifestyle interventions. Trial registration Chinese Clinical Trial Registry: ChiCTR1800020411; Date of registration: December 28, 2018.


2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022


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