Effectiveness of Home-monitoring of Blood Pressure in Patients with Therapy Resistant Hypertension

Hypertension is the strongest modifiable risk factor for cardiovascular disease, the leading cause of death worldwide. Nearly one in four adults in the world is suffering from hypertension (Chockalingam, Campbell, & Fodor, 2006). Between 1975 and 2015 the number of adults with hypertension increased threefold to 1.13 billion, with the increase largely in low- and middle income countries (Zhou et al., 2017). The importance of hypertension as modifiable risk factor has been acknowledged long since, which has led to many effective and inexpensive treatments (Chow et al., 2013). However, its global incidence, prevalence and cardiovascular complications are not reduced, partly due to inadequacies in prevention, diagnosis and control (Olsen et al., 2016). In 2010, less than half of adults with hypertension were aware of their condition, little over one in three were treated and as little as 14% had their blood pressure under control (Mills et al., 2016). The emergence of new technologies in the current digital era potentially has an important role in the in improving these numbers (Olsen et al., 2016).

Telemonitoring, in which patients measure their blood pressure themselves, which is consequently remotely checked by a healthcare team, is one such approach. Strong evidence suggests that home-monitoring of blood pressure, if combined with additional support such as telecounseling or web feedback, significantly lowers blood pressure in patients with hypertension compared to usual care (Earle et al., 2017). However, adding technological innovation might drive unit healthcare costs upwards and therefore have a negative impact on cost-effectiveness. In addition, telemonitoring requires new payment schemes that take into account the use of devices and applications operated by the patient and the availability of a remote healthcare team to interpret and analyse the home-measurements. So far, the lack of financial sustainability and adequate reimbursement schemes has prevented telemonitoring from a wide and successful implementation (Lindeman et al., 2016) (Hashemi, Nourbakhsh, Tehrani, & Karimi, 2018).

The Dutch HartWacht initiative was one of the first programs that introduced an innovative payment scheme in order to get mHealth fully reimbursed. The payment method shifted from the traditional fee-for-service scheme towards a bundled payment scheme. In co-operation with insurance companies the tariffs for the bundled payment were established in such a way that total costs per patient couldn’t exceed the costs of usual care. Thereby, cost-effectiveness of the program was secured as long as clinical outcomes wouldn’t deteriorate.

The feasibility of HartWacht in achieving blood pressure control for its participants has been proven in previous preliminary research. 122 patients started the HartWacht program for hypertension (female: 57 (46,7%); mean age: 61,2 (±9,5) years); mean follow-up: 13,4 (±7,6) months; mean number of anti-hypertensive drugs at start of HartWacht: 1,8 (±0,9); mean number of medication changes per year during follow-up (including changes in dose): 1,0 (±1,6); mean number of contact moments per year during follow-up (telephone calls with dedicated nurse or treating cardiologist): 4,9 (±5,0). At final follow-up, 67 patients participated at least one year. Others started later or stopped the program, mainly because of reaching normotensive values (n=22; home BP < 135/85).

The mean last office SBP measurement (n=122) was 157,9 mmHg (±19,2). The mean home SBP in the first week (n=120) was 139,9 mmHg (±13,9). After 3 months the mean home SBP lowered to 133,8 mmHg (±14,9), a significant decrease compared to week 1 (mean: 6,1 (±13,8), p<0,001). After this moment the mean home SBP was stable: 132,5 mmHg (±12,6) at six months (n=99) and 132,2 mmHg (±12,4) at 12 months.

The HartWacht program has proven to be feasible for achieving blood pressure control of patients with office hypertension. Its effect on blood pressure of therapy-resistant hypertensive patients, compared to a control group, however remains unclear. The aim of this research is to investigate the effect on blood pressure of the home-monitoring program HartWacht compared to usual care.

In patients that participate in HartWacht, the blood pressure will be significantly lower compared to patients that receive usual care, six months after baseline.

Baseline. Follow-up: 6 months.

The HartWacht home monitoring program. See above.