Telemonitoring and E-Coaching in Hypertension (TECH)

Maasstad Hospital

Status: Enrolling

Conditions: Hypertension

Treatments: Other: Home blood pressure monitoring (telemonitoring); Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT05660226

82758

Details and patient eligibility

About

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)

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Home blood pressure monitoring + E-coaching

Treatment:

Other: Home blood pressure monitoring (telemonitoring)

Control

Placebo Comparator group

Description:

Standard care in patients with hypertension

Treatment:

Other: Standard care