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Wearable equipment-based telemedical management via multiparameter monitoring on cardiovascular outcomes in elderly patients with chronic coronary heart disease: an open-labelled, randomised, controlled trial

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Discussion

This study depicted the sustainable engagement feasibility for a 12-month telemedical management with wearable equipment to optimise self-management of CHD. This study resulted in a modest reduction of the incidence of hospitalisation and MACEs. Such effect appeared to be mainly attributed to a significant reduction in the secondary outcomes. Moreover, long-term care for chronic diseases is necessary, but frequent outpatient visits are unlikely to be achieved, which could impose a great time and financial burden. These findings highlight the potential utility of telemedical management to augment existing public health services for elderly patients with CHD.

The telemedical management in this study noted an overt drop in the levels of SBP, FBG and LDL-C, by −10.6±17.2 mm Hg, −0.62±1.61 mmol/L and −0.43±0.86 mmol/L, respectively. The results were comparable although lower than those reported in the WellCare clinical trial, where the changes in SBP and FBG were −13.7 mm Hg and −0.83 mmol/L, respectively.22 In our study, most participants in this study were diagnosed with CHD and had a higher median age of 75 years, which may explain the lower reduction in SBP and FBG compared with the WellCare clinical trial.

This study demonstrated a reduction in the incidence of hospitalisations and MACEs via telemedical managements. We found that remote monitoring and management demonstrated a positive impact on the health management of chronic disease risk factors control. We observed little effect of prespecified subgroups on the difference of the primary endpoints between TFM and WTM groups, except the gender subgroup with regards to the hospitalisation endpoint (pinteraction=0.028). Since multiple studies have shown that the risk of CVD in elderly women increases with age, eventually equaling the lifetime risk observed in men.23 Since the sample size decreased after subgroup analysis in this study, we interpreted these results with caution. However, since wearable equipments were provided to participants at no cost, a cost-effectiveness analysis still needs to be further conducted. Additionally, future research should account for challenges such as patient privacy, adherence, physician workload and economic sustainability, etc.

In this study, modifiable risk factors were better controlled in WTM group. Telemedical management was efficient in the improvement of medication adherence in WTM than that in TFM group, which was consistent with the result in the CHAT-DM study.24 Furthermore, arrhythmia and ST-T changes in dynamic ECG were included in the statistical and intervention indices. In a previous study, the sensitivity of ST-T changes in Holter ECG examination was 32.2%.25 There was a slightly higher sensitivity for detecting myocardial ischemia in the elderly patients with CHD than that in young cases. In our study, the sensitivity of ST-T changes in Holter ECG examination was 49.2% in 417 patients, which was relatively higher than 32.2%. And there was an improvement in ST-T changes according to the regular Holter ECG examinations (p=0.034) in 51 (51.1%) patients in WTM group and 39 (36.8%) patients in TFM group. The improvement in ST-T changes may be due to telemedical management.

Multimorbidity, the coexistence of at least two chronic diseases in the same individual, is common among the elderly.26 It requires patient-centred care that does not routinely prioritise any single condition.2 27 However, most studies on chronic disease are limited to ‏mono chronic diseases.28 In our study, multimorbidity was present in over 90% of the participants. Elderly comorbidity will need multiple discipline therapy to work together and make decision. However, few ‏wearable health monitoring equipments perform multiparameter monitoring for comorbidity in the elderly. Additionally, most current prospective interventional studies on telemedicine suffer from pitfalls including small sample sizes and short follow-up ‏period. To address these issues, our study conducted a prospective randomised controlled cohort study including 1248 subjects, with a follow-up time up to 1 year. After a 1 year management, we analysed the control effect of telemedicine on elderly patients with CHD and its risk factors. Although the multiparameter monitoring employed in this study was accomplished with several equipments, with the assistance of real-time management, the telemedical management was proven to be effective. The use of multiple equipments still needs to be further evaluated for simplicity in the future. However, it is important to notice that the intermittent clinical visits continue to be a crucial component of healthcare services. We expect that the use of wearable equipment will play an increasingly significant role in this process. Similarly, in this study, given the existing medical conditions, the wearable equipment-based telemedicine model was not entirely independent of traditional clinical visits. Participants in TFM group still had in-person clinical visits at least once every 6 months. Therefore, when analysing the results, it is not possible to attribute the statistically significant differences solely to the effects of remote management.

Telemedicine has been helpful in the management of several pandemics, including former coronavirus outbreaks such as SARS-CoV-2.29 Our study was conducted during the COVID-19 pandemics. This outpatient telemedicine was proven to be effective in reducing patient travel and outpatient visits and display better management outcome compared with traditional outpatient service. The combination of telemedicine, instant clinical data transfer, real-time remote monitoring and personalised medicine might shape the future of longevity care. However, several challenges remain for the globalisation and integration of telemedicine into public health. Some countries lack a complete regulatory framework to authorise, integrate and reimburse telemedicine in healthcare delivery for patients, particularly in emergency and pandemic situations.30 The present study may represent a more realistic picture of self-management due to the usage of wearable equipment. More qualitative scrutiny on the participant’s motivation with regards to the use of the wearable equipment is required to shed light on adherence to and motivation to use wearable equipment. The prevention and management of chronic diseases in the elderly require a multifaceted approach.

While our study addresses some of the limitations of previous research, it still has several limitations. First, the baseline comparison after randomisation showed statistically significant differences in SBP and FBG levels between the two groups. In future studies, we will pay more attention to the setting of the randomisation protocol. Second, as this study was an open-labelled trial, investigators were not masked to the group allocation, which may cause bias in both the baseline data and follow-up managements. Moreover, the telemedical management in this study could not be completely distinguished from the traditional follow-up management, which could potentially induce bias in evaluating the effectiveness of the telemedical management. Lastly, this study did not place sufficient focus on medication adherence, satisfaction with device usage and the related costs, all of which are relevant to the implementation of telemedical management in the future.

In conclusion, this study demonstrated a preventive measure of telemedical management with wearable equipment in elderly patients with CHD, which can deliver more effective care beyond traditional clinician-patient settings and offer substantial benefits for the secondary prevention of CHD. Telemedical management based on wearable equipment further improves the out-of-hospital management in this study. We believe that the outpatient telemedical management might be an effective supplement for in-person clinical visits, which will form an effective closed loop with in-hospital treatment and improve the disease management for elderly patients with chronic diseases.

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