Telemonitoring and E-Coaching in Hypertension

Study 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)

Official Title
-----------------
Telemonitoring and E-Coaching in Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Home blood pressure monitoring (telemonitoring)
* Other: Standard care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Home blood pressure monitoring + E-coaching | Other: Home blood pressure monitoring (telemonitoring)<br>* 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)<br>|
| Placebo Comparator: Control<br>Standard care in patients with hypertension | Other: Standard care<br>* Standard outpatient blood pressure management<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension control rate | Percentage of patients with blood pressure on target (RR<135/85) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | Mean systolic and diastolic blood pressures for both groups | 6 weeks, 6 months and 12 months | 
| Medication use | Biochemical assessment of antihypertensive medication concentrations in blood. Number of antihypertensive agents used at 6 months. Number of antihypertensive medication changes at 6 months. | 6 weeks, 6 months and 12 months | 
| Self-management | Self-efficacy to monitor blood pressure, effect of coaching on disease insight and skills using PAM 13 and EQ5DL questionnaires | baseline and 6 months | 
| Patient and Healthcare provider Satisfaction | Patients and health-care provider satisfaction as measured with TUQ and MAUQ questionnaires. The scales are from 1 to 7 (disagree to agree) | 6 months and 12 months | 
| Hospitalizations | Hospitalizations resulting from poor blood pressure control or cardiovascular complications resulting from poor blood pressure control (hypertensive emergencies, MI's, stroke) | 6 months and 12 months | 
| Adverse cardiovascular events | Myocardial infarction, cerebrovascular events and hypertensive emergencies. | 6 months and 12 months | 
| Hypertension control rate | Percentage of patients with blood pressure on target (RR<140/90) | 6 weeks and 12 months | 
| Direct Medical Costs | Costs related to HBPT (blood pressure monitor costs) Costs related to additional prescribing of antihypertensive drugs Costs related to a physical appointment for patients in a hypertension care pathway Costs related to reimbursement for patients in a HBPT program Costs related to hospital admissions resulting primarily from poorly controlled hypertension or hypertensive emergencies. Costs related to hospital admissions or required care pathways following a cardiovascular complication as a result from poorly controlled hypertension Future related medical costs | 6 weeks, 6 months and 12 months | 
| Direct Non-Medical Costs | Training costs related to the use of HBPT for both telenurses, nurse specialists and clinicians Development and exploitation costs (time spent developing the HBPT protocol, license costs for the application) Salaries for involved health care providers during HBPT | 6 weeks, 6 months and 12 months | 
| Indirect Non-Medical costs | Costs related to work absence (loss of productivity for short-term absence, friction cost for long-term absence) Costs related to the hospital visit (travel costs, parking costs) | 6 weeks, 6 months and 12 months | 
| Indirect medical costs | o Future unrelated medical costs (as calculated using the iMTA PAID module: costs related to other diseases due to improved life expectancy | 6 weeks, 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemonitoring, Hypertension, E-Health, Coaching