Telemonitoring and E-Coaching in Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-03-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Home blood pressure monitoring + E-coaching

Group Type EXPERIMENTAL

Home blood pressure monitoring (telemonitoring)

Intervention Type OTHER

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)

Control

Standard care in patients with hypertension

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type OTHER

Standard outpatient blood pressure management

Interventions

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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)

Intervention Type OTHER

Standard care

Standard outpatient blood pressure management

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Hypertension (\>140/90)
* Have and use a smartphone or a partner/caregiver who is able to provide the necessary technical support
* Able to provide written informed consent prior to participation in the study

Exclusion Criteria

* Current user of a blood pressure monitor apporoved by the Dutch Heart foundation in combination with the Luscii app
* Persistent atrial fibrillation as indicated in the electronic health record (EHR)
* Pregnant or planning to become pregnant during the study period
* Severe kidney disease, defined as estimated glomerular filtration rate \<30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
* Unable to communicate (not language specific)
* Recent cardiovascular event (ischemic stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months
* Diagnosis of dementia, psychosis as indicated in the electronic health record
* Life expectancy \<1 year, for instance in terminal cancer or NYHA III or IV heart failure
* Individuals requiring BP monitor cuff size larger than 42cm
* Patients with proven secondary cause of hypertension for which drug treatment is not first choice (e.g. excessive licorice use, proven renal artery stenosis etc)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No