Telemonitoring and E-Coaching in Hypertension
Maasstad Hospital
400 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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)
Interventions
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)
Standard outpatient blood pressure management
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05660226