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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 BV]
卷期号:1 (7): e363-e374 被引量:151
标识
DOI:10.1016/s2589-7500(19)30151-7
摘要

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).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.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.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.Curtin University.
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