Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial

医学 康复 物理疗法 心理干预 不利影响 随机对照试验 二级预防 临床试验 内科学 护理部
作者
Tashi Dorje,Gang Zhao,Khandro Tso,Jing Wang,Yaolin Chen,Lhamo Tsokey,B-K Tan,Anna Scheer,Angela Jacques,Zhixing Li,Ruochen Wang,Clara K Chow,Junbo Ge,Andrew Maiorana
出处
期刊:The Lancet Digital Health [Elsevier]
卷期号:1 (7): e363-e374 被引量:122
标识
DOI:10.1016/s2589-7500(19)30151-7
摘要

Summary

Background

Coronary heart disease is rapidly increasing in developing countries, but access to cardiac rehabilitation and secondary prevention remains low. In this study, we aimed to assess the effectiveness of a smartphone-based cardiac rehabilitation and secondary prevention programme delivered via the social media platform WeChat (SMART-CR/SP).

Methods

In this parallel-group, single-blind, randomised controlled trial, we recruited patients aged 18 years or older with coronary heart disease who had received percutaneous coronary interventions from a large tertiary hospital in Shanghai, China. Participants were randomly assigned (1:1) by block randomisation to either a 2-month intensive programme followed by a 4-month step-down phase of SMART-CR/SP or to usual care. In the SMART-CR/SP group, participants received comprehensive cardiac rehabilitation and secondary prevention via WeChat. The usual care group received standard outpatient cardiology follow-up but without formal cardiac rehabilitation and secondary prevention. Assessments were done at baseline, 2 months, 6 months, and 12 months. The primary outcome was change in functional capacity from baseline, measured by 6-min walk distance, at 2 months and 6 months. Analysis was by intention to treat. Research personnel involved in assessments were blinded to group allocation. Adverse-event analysis was based on percentage of patients who discontinued the study owing to adverse events. SMART-CR/SP programme-related safety issues were also recorded. This study was registered with the Chinese Clinical Trial Registry, number ChiCTR-INR-16009598.

Findings

Between Nov 17, 2016, and March 18, 2017, 312 patients (mean age 60·5 years [SD 9·2]), of whom 58 (19%) were female and 254 (81%) were male, were recruited and subsequently randomly assigned to SMART-CR/SP (n=156) or usual care (n=156). The improvement in 6-min walk distance at 2 months was significantly greater in the SMART-CR/SP group (from 489·2 m [99·4] at baseline to 539·1 m [68·0]) than in the control group (from 485·0 m [93·5] at baseline to 517·8 m [74.6]), with an adjusted mean difference of 20·64 m (95% CI 7·50–33·77; p=0·034). This improvement was maintained at 6 months (mean 6-min walk distance 543·4 m [67·5] in the SMART-CR/SP group vs 523·5 m [60·2] in the control group), with a mean between-group difference of 22·29 m (8·19–36·38; p=0·027). No adverse events or SMART-CR/SP programme-related safety issues were reported by participants during the study.

Interpretation

SMART-CR/SP was found to be a cardiac rehabilitation and secondary prevention service model with high efficacy and accessibility and to be easy to use. These results justify the implementation of similar models of care on a broader scale.

Funding

Curtin University.
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