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Not Yet Recruiting NCT05660226

Telemonitoring and E-Coaching in Hypertension

Conditions: Hypertension

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 400
Sponsor: Maasstad Hospital

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)

Eligibility Criteria

Inclusion Criteria:Age ≥18 yearsHypertension (>140/90)Have and use a smartphone or a partner/caregiver who is able to provide the necessary technical supportAble to provide written informed consent prior to participation in the studyExclusion Criteria:Current user of a blood pressure monitor apporoved by the Dutch Heart foundation in combination with the Luscii appPersistent atrial fibrillation as indicated in the electronic health record (EHR)Pregnant or planning to become pregnant during the study periodSevere 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 monthsDiagnosis of dementia, psychosis as indicated in the electronic health recordLife expectancy <1 year, for instance in terminal cancer or NYHA III or IV heart failureIndividuals requiring BP monitor cuff size larger than 42cmPatients with proven secondary cause of hypertension for which drug treatment is not first choice (e.g. excessive licorice use, proven renal artery stenosis etc)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05660226). StuddyBuddy aggregates publicly available trial information.