Clinical trial NCT05660226: Telemonitoring and E-Coaching in Hypertension
Official title: Telemonitoring and E-Coaching in Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Telemonitoring
Hypertension
E-Health
Coaching
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Albert Schweitzer Hospital
name: Sint Franciscus Gasthuis
First posted: 2022-12-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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)

Primary outcomes:
measure: Hypertension control rate
timeFrame: 6 months
Secondary outcomes:
measure: Blood pressure control
timeFrame: 6 weeks, 6 months and 12 months
measure: Medication use
timeFrame: 6 weeks, 6 months and 12 months
measure: Self-management
timeFrame: baseline and 6 months
measure: Patient and Healthcare provider Satisfaction
timeFrame: 6 months and 12 months
measure: Hospitalizations
timeFrame: 6 months and 12 months
measure: Adverse cardiovascular events
timeFrame: 6 months and 12 months
measure: Hypertension control rate
timeFrame: 6 weeks and 12 months
measure: Direct Medical Costs
timeFrame: 6 weeks, 6 months and 12 months
measure: Direct Non-Medical Costs
timeFrame: 6 weeks, 6 months and 12 months
measure: Indirect Non-Medical costs
timeFrame: 6 weeks, 6 months and 12 months
measure: Indirect medical costs
timeFrame: 6 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
Study officials:
References: