Telemonitoring of elderly with hypertension and type 2 diabetes at the primary care level: Protocol for a multicentric randomized controlled pilot study

Arterial hypertension (AH) and type 2 diabetes (T2D) are leading chronic diseases that frequently co-occur, share the same risk factors, and together account for nearly 70% of all-cause deaths (1). The prevalence of their comorbidity increases with age and is particularly high in the elderly group. It is estimated that up to 75% of patients aged ≥65 years have AH, while 25% have T2D (2, 3). Despite the potential for successful treatment, their prevalence is steadily increasing (2, 3). Consequently, these global trends place a significant burden on population health and a financial burden on healthcare systems (2, 3).

One approach to reversing the rising trends, empowering chronic patients, and reducing the incidence of secondary complications from uncontrolled blood pressure (BP) and blood glucose (BG), could be integrated care supported by BP and BG telemonitoring (1, 4, 5, 6). Telemonitoring is a subset of telemedicine and refers to the transmission of physiological data, such as BP and BG values, via automated electronic means or via web-based or telephone data. The data received allows physicians to interpret the data synchronously and make timely decisions about the patient’s treatment (5, 6, 7). Currently, telemonitoring is often combined with teleconsultations, which can be synchronous via videoconferencing devices or asynchronous via email, internet, or mobile phones (57). The combination of frequent BP/BG measurements and timely feedback/consultation from the registered nurse or physician is the main reason why telemonitoring has the potential to significantly improve clinical outcomes (5, 6, 7, 8). In addition, telemonitoring indirectly promotes patient empowerment by increasing their engagement, knowledge, and skills needed to manage their disease (8).

Previous studies have found that BP and BG telemonitoring combined with teleconsultations lasting 12 months or longer had the greatest effect on BP and BG reduction, while isolated interventions lasting 6 months or less were unsuccessful in the long term (1, 5, 7, 9). Meta-analyses of randomized clinical trials examining the clinical effectiveness of BP and BG telemonitoring found a 5-mmHg reduction in SBP and a 0.3% reduction in HbA1c compared with standard care 12 months after study inclusion (1, 5, 7, 9). More complex telehealth interventions may yield even better results, but are associated with higher costs (10).

In Slovenia the healthcare system is based on the Bismarck model, which provides equal and fair access to health care for all patients (4). In 2011, a new working model was introduced in Slovenian family medicine practices. A registered nurse was added to the team consisting of a family physician and a practice nurse. A registered nurse took over the preventive activities and management of patients with stable chronic diseases (including AH and T2D), providing standardized and integrated care at the level of screening, treatment, education, and quality control (11). Patients with AH or T2D are seen by their family physician and registered nurse at least once a year. The physician examines patients, refers them to the laboratory, assesses disease control and the need for titration of therapy, while the registered nurse screens patients for AH/T2D complications, assesses their psychosocial status, educates them about non-pharmacological measures, and refers them to additional health promotion activities within the health education centre, including nutritionists, psychologists or psychotherapists, as appropriate (11, 12). A general problem with previous research is that it has neglected the central role of primary care in the management of chronic diseases, such as AH and T2D. Clinical pathways have generally been designed to be conducted in clinical settings rather than small healthcare centres. Studies were conducted in younger, motivated patients with either AH or T2D, rather than in older, multimorbid patients with little knowledge about the use of modern technologies. The latter have the highest risk of cardiovascular mortality and could benefit significantly from telemonitoring interventions (13). Furthermore, a high threshold for clinical significance in relation to BP and BG reduction calls into question the clinical relevance of telemonitoring. Currently, a 10-mmHg decrease in systolic BP (SBP) and a 0.5% reduction in glycated haemoglobin (HbA1c) are considered clinically relevant (14, 15). Moreover, there is a need for additional evidence on the acceptability of telemonitoring in the elderly group.

From the perspective of the Slovenian healthcare system, there is currently a lack of self-management support for patients with AH and T2D (4, 16). In addition, the challenges of the ageing population and the shortage of primary care physicians require the testing of care models that shift responsibility for their health vertically to patients to a greater extent (16).

Finally, there is insufficient evidence on the cost-effectiveness of telemonitoring interventions to drive our research. Previous studies have found telemonitoring to be more cost-effective in patients with T2D, while cost-effectiveness was achieved in a group of patients with AH assuming a lifetime telemonitoring effect (17, 18). This was found with an incremental cost-effectiveness ratio (ICER) of £20,000 per quality-adjusted life year (QALY) (17). Currently, a higher ICER threshold of €25,000/QALY is considered cost-effective in Slovenia (19). A cost-effectiveness analysis in a group of elderly patients with AH and T2D at the primary care level has not yet been published.

This study thus aims to test the acceptability, clinical effectiveness, and cost-effectiveness of telemonitoring in elderly patients with AH and T2D at the primary care level. The specific goals of the study are: (a) to assess the effect of telemonitoring on observed clinical variables and quality of life indexes up to 12 months after inclusion, (b) to compare the difference in costs relative to the difference in QALY between telemonitoring and standard care group 12 months after inclusion, and (c) to assess acceptability of telemonitoring among elderly patients and healthcare workers.

This is the first study to investigate the feasibility, clinical effectiveness, and cost-effectiveness of BP and BG telemonitoring in elderly patients with comorbid AH and T2D at the primary care level.

In previous studies, older multimorbid patients were often excluded because they could not use modern technologies, were not motivated to participate in the study, or needed additional support from family members (1, 5, 7). According to recent projections, the global population of people over 65 years of age will more than double by 2050, while the proportion of elderly people in the global population will increase from 9% to 16% (34). Therefore, exploring novel approaches such as telemonitoring to promote patient-centred care focused on quality of life and self-management support is essential.

The reason for the slow integration of telemonitoring into daily practice could be its unconvincing clinical and cost-effectiveness (5, 7, 17, 18). From the healthcare workers’ perspective, the main barriers are the lack of adaptation to workflows within practices, concerns about creating anxiety and dependency, and fear of additional workload (35). All these concerns should be taken into account when developing future models of care.

The strength of this pilot study lies in the sufficient follow-up time, the multi-centre randomized controlled nature, the complexity of the observed outcomes, and the originality of the population observed. Moreover, we designed the inclusion criteria to include not only patients with derailed BP (>150/100 mmHg) and HbA1c (>7.5%) values, but also those with relatively well-controlled parameters. This was done to capture the population that would otherwise be treated at the primary care level. This could result in lower observed differences, but will give us diversity in the observed population, which will also be reflected in the results of the qualitative content analysis. Due to multimorbidity, intensive BP measurement regimen, and difficulty in completing regular check-ups with their GPs and specialists in the control group during the COVID-19 pandemic, we expect to observe larger differences between groups compared to previous studies (1, 5, 7). In terms of cost-effectiveness, we expect an increase in EQ-5D-5L and EQ VAS index scores. However, based on previous evidence, the threshold for cost-effectiveness may not be reached (17, 18).

Finally, there might be limitations in our study design. Due to the pilot nature of the study and the relatively small sample size, the power of the study will be low. In addition, we defined SBP and DBP values at baseline and follow-up as 7-day BP averages of morning and evening readings, although the gold standard is still the 24-hour average of BP monitoring (20). This was done for practical reasons, and is more reliable than in previous studies where the mean of the second and third ambulance readings was used as the primary outcome (29). Furthermore, there are some common risks of randomized controlled trials, such as loss to follow-up, the risk that randomized patients are not representative of the population studied, and imbalance between groups in baseline variables, which may affect the results.

This study will provide new evidence for scaling up a telemonitoring network at the primary care level and modifying telemonitoring protocols to achieve the best clinical and cost-effective outcomes, and good patient adherence. Further studies should examine a larger population and follow patients for at least 5 years to assess long-term outcomes. However, without recognition of telemonitoring as an essential component of chronic patient care by policymakers, further large-scale and long-term expansion is questionable.