Discussion
International guidelines and position papers recommend that measurement of outcomes at the EOP should be a core component of modern CR programmes.18 19 However, this has been particularly challenging to achieve during the COVID-19 pandemic. To our knowledge, this is one of the first studies to report both short and longer-term clinical, lifestyle and psychosocial outcomes from a digital CR programme delivered during the pandemic. Consistent with recent systematic reviews,10 11 our study shows that it is feasible to deliver comprehensive CR remotely and achieve the recommended lifestyle, medical and therapeutic targets that are known to be associated with reduced CVD events and improved health outcomes.1
Furthermore, while acknowledging the small sample size and different patient cohorts, the findings of the Croí MySláinte digital CR programme compare favourably to published outcomes for the in-person MyAction programme previously delivered in Galway (Ireland) and in Westminster (UK).16 24 For example, at MySláinte EOP, the proportions achieving the recommended targets for LDL increased by 27% (14% at IA to 41%at EOP), versus 6.3% (48.2% at IA to 54.5% at EOP) and 23.8% (25.2% at IA to 49% at EOP) for the Westminster and Galway programmes, respectively. Similarly, EOP proportions achieving the recommended targets for blood pressure in MySláinte increased by 44% (24% at IA–68% at EOP), versus 15.3% (70.3% at IA to 85.6% at EOP) and 25.3% (51.6% at IA to 76.9% at EOP) for the Westminster and Galway programmes, respectively. For physical activity, mean functional capacity increased by 2.1 (7.9 at IA to 10 at EOP) MET maximum in comparison to 0.9 (7.6 at IA to 8.5 at EOP) on the Westminster and 1.7 (7.5 at IA to 9.2 at EOP) on the Galway programme. Furthermore, the reductions in anxiety and depression levels (HADS ≥8) of 23% (40% at IA to 17% at EOP) and 12% (22% at IA to 10% at EOP) compared favourably with those achieved on the Westminster programme of 1.55% (27.8% at IA to 26.3% at EOP) and 11.6% (23.2% at IA to 11.6% at EOP) and the Galway programme of 12.1% (32.5% at IA to 20.4% at EOP) and 10.9% (18.2% at IA to 7.3% at EOP). 16 24
These findings may be due to Croí MySláinte’s increased emphasis on self-management and the provision of tools such as home blood pressure monitors and Fitbit wearables. Self-management DHIs have been shown to be an effective treatment for the management of hypertension, with two recent systematic reviews reporting improved systolic and diastolic control and medication adherence in comparison to the control groups.25 26 Furthermore, the meta analysis results of 17 randomised controlled trials (RCTs) in a systematic review by Kirk et al showed wearable devices significantly increased both steps and moderate to vigorous physical activity in CVD patients.27
Furthermore, in contrast to the in person MyAction programme, the prescribing and optimisation of cardioprotective medication in MySláinte was initiated by a nurse prescriber, with cardiologist, GP and pharmacist support. This helped ensure efficient guideline-driven management of lipids and blood pressure at a time when access to general practice and hospital-based cardiology support was limited. While there were modest improvements in the use of most cardioprotective medications, these were not significant, the exception being increased prescribing of other lipid lowering agents and up titration of statin doses. It is likely that the significant reductions to blood pressure and LDL cholesterol were due to a combination of increased prescribing, dose-changes, support with medication adherence and lifestyle modification. Consistent with Cochrane systematic review evidence,28 findings from this study highlight the important role of non-medical prescribing by nurses and wider implementation of this practice in CR DHIs, should be considered.
In keeping with findings by Candelaria et al and Huang et al,29 30 our study showed that CR DHIs can significantly improve health related quality of life and anxiety and depression at EOP, with the majority of these changes being sustained at 6-month follow-up. These improvements can be attributed to the strong emphasis placed on addressing psychosocial health through group-based activities, stress management and psychological support. The timing of this support was particularly important given the reported increase in pandemic related psychological distress, including social isolation among patients with CVD.31 Furthermore, it is well established that a healthy diet and regular physical activity can positively impact on quality of life and symptoms of anxiety and depression.1
A key feature of our programme was the delivery of a remote programme of supervised exercise training. Recent survey data highlighted that only 25.5% of CR centres globally provided supervised exercise training in the first few months of the pandemic.6 We achieved this through individualised risk assessment, supported by functional capacity testing using the sub maximal Chester Step Test, and monitoring through Fitbit and live video conferencing.
Multiple studies have demonstrated that effective diet and weight management interventions can be delivered using DHIs.32 We observed significant improvements in self-reported adherence to the Mediterranean diet (+2.1 units, p<0.001) and reductions in BMI (−1.0, p<0.001) and weight (−2.6 kg, p<0.001), which were sustained at 6-month follow-up.
Programme participation
The high programme uptake and retention rates are consistent with existing evidence which shows that adherence to DHIs is not inferior to in person CR programmes.10 It is likely that the support and training provided to patients in the use of the programme technology helped enable access and increase participation. Of note, we observed that 56% of programme participants (n=43) were living in rural areas, suggesting that the convenience of less travel may have been an important factor in influencing attendance. Despite waiting on average 8 weeks for referral to CR, once referred, patients received access to Croí MySláinte within 3 weeks. The need for timely CR is well established, with guidelines recommending that CR should start as early as possible after a cardiac event.1 33 However, in reality global access and uptake of CR remains consistently poor,2 with a recent Irish survey reporting that 40% of patients are waiting at least 3 months for CR.34 This highlights the potential role that digital CR programmes such as Croí MySláinte could play in broadening CR access, minimising waiting times and ensuring consistent delivery of services beyond the pandemic.
Delivering the core components
Notwithstanding the rapid implementation of Croí MySláinte, a key strength of the programme was its focus on delivering the internationally recommended core components (medical and lifestyle risk factor management, health behaviour change, psychosocial health and cardioprotective medications), which are necessary to achieve optimal CR benefits.18 19 It is highly likely that the inclusion of these components contributed to the significant clinical outcomes achieved on Croí MySláinte. In contrast, there is significant heterogeneity in the delivery of the core components in CR DHIs with a recent systematic review by Wongvibulsin et al highlighting that from 31 selected studies of DHIs only 6 included 5 or more of the recommended CR components with risk factors such as smoking cessation, lipid management and blood glucose levels being poorly addressed.10 While there have been increasing calls by organisations such as the EAPC to maintain the delivery of the core components during the pandemic, this proved difficult for many centres, where limiting the provision of elements such as supervised exercise training and initial and EOP assessments was essential to retain some level of service.6 32 35 The successful delivery of the core components on Croí MySláinte can be attributed to the skilled interdisciplinary team of healthcare professionals, who together with the technologies employed helped to ensure that a tailored programme of care that aligned to the patients’ needs and risk factor profile was offered.
Limitations
There are a number of limitations to our study. First, cause and effect cannot be inferred due to the observational nature of the study design. For example, CVD risk factors may have been improving in the patients enrolled as a function of their usual care and not due to the intervention. As such, future research should ideally include a comparison group preferably based in the same centre. However, it is reassuring that our virtual Croí MySláinte intervention is almost identical to the in-person intervention delivered during the EuroAction trial (this trial did have a comparison group and did demonstrate superior efficacy for the intervention relative to control)17 Second, despite participants being recruited from five hospital sites in Ireland, the generalisability of our findings may be limited, as these sites were located in one region of Ireland. Nonetheless, the results are comparable to those achieved in international face-to-face programmes on which Croí MySláinte is modelled. Third, there was the potential for selection bias as patients who were more motivated and engaged in their health may have been more likely to participate, however the suboptimal control of risk factors at baseline could suggest otherwise (table 1). Furthermore, as patients were required to have an internet connection and access to either an iPad/laptop this potentially excluded those with low digital health literacy. For DHIs to reach their full potential, consideration must be given to health literacy and ensuring equitable access to technologies. Moreover, to understand the potential inequalities associated with DHIs, future research needs to be more inclusive of marginalised populations such as ethnic minorities and socioeconomic deprived groups and, where possible, sources of inequalities should be reported so that effective strategies can be developed to address them. Fourth, as this study was conducted during two National lockdowns, the imposed restrictions impacted on the ability to collect outcome data in a standardised way for all participants, for example, CR centres may have used different equipment such as weighing scales and bloods may have been sent to different laboratories for analysis. In addition, many participants found it difficult to secure appointments with their GPs for bloods; this resulted in incomplete data for some risk factors. Finally, while the focus of this study was on evaluating service and patient outcomes, there is also a need to explore the patient and healthcare professional’s perspectives of DHIs. This will help inform future development of digital CR programmes and the systems required to support implementation and scalability. To address this the authors are conducting qualitative research in this area.