Telemonitoring and E-Coaching in Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Maasstad Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Hypertension control rate
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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)
Investigators
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)
Outcomes
Primary Outcomes
Hypertension control rate
Time Frame: 6 months
Percentage of patients with blood pressure on target (RR\<135/85)
Secondary Outcomes
- Medication use(6 weeks, 6 months and 12 months)
- Blood pressure control(6 weeks, 6 months and 12 months)
- Self-management(baseline and 6 months)
- Patient and Healthcare provider Satisfaction(6 months and 12 months)
- Hospitalizations(6 months and 12 months)
- Adverse cardiovascular events(6 months and 12 months)
- Hypertension control rate(6 weeks and 12 months)
- Direct Non-Medical Costs(6 weeks, 6 months and 12 months)
- Indirect Non-Medical costs(6 weeks, 6 months and 12 months)
- Indirect medical costs(6 weeks, 6 months and 12 months)
- Direct Medical Costs(6 weeks, 6 months and 12 months)