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Telemonitoring and E-Coaching in Hypertension

NCT05660226 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-04-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • Albert Schweitzer Hospital

    collaborator OTHER

  • Sint Franciscus Gasthuis

    collaborator OTHER

  • Maasstad Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • Netherlands

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660226 on ClinicalTrials.gov