NCT05660226

Telemonitoring and E-Coaching in Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Maasstad Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Hypertension is the most significant risk factor for cardiovascular disease and can be mitigated by lifestyle and medical management. Telemonitoring as a novel management approach to perform hypertension management at distance has been thriving but became indispensable during the COVID-19 pandemic. However, evidence of an effective implementation for telemonitoring remains to be elucidated. Hypothesis: Telemonitoring with a smartphone application, which includes mixed automated services for a personal counselling program (PCP), on top of self-monitoring (SM) will lead to improvement of hypertension control rates, medication adherence and lifestyle behaviors and lower health care costs in patients with hypertension when compared to usual care. Objective: To investigate the effects of PCP+SM on hypertension control rate and lifestyle behaviors as compared with usual care. Study design: The study is a non-blinded randomized controlled clinical trial in adults with hypertension, in a multicenter hospital setting . We will randomize participants in a 1:1 fashion to the intervention group (PCP+SM), or to the control group (usual care). Study population: 400 patients, patients, aged ≥18 years with hypertension (RR \>140/90) Main study outcome: hypertension control rate (%\<140/90mmHg) after 6 months (as measured by the SPRINT protocol)

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Home blood pressure monitoring (telemonitoring)	Using a digital mobile phone based telemonitoring platform to A: monitor patients and adjust their treatment accordingly based on the remote monitoring outcomes and B: provide E-Coaching/self learning modules (lifestyle)
OTHER	Standard care	Standard outpatient blood pressure management

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2022-12-21
• Last updated: 2023-04-13

Locations

1 site across 1 country: Netherlands