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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Albert Schweitzer Hospital | OTHER |
| Sint Franciscus Gasthuis | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Home blood pressure monitoring + E-coaching |
|
| Control | Placebo Comparator | Standard care in patients with hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home blood pressure monitoring (telemonitoring) | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension control rate | Percentage of patients with blood pressure on target (RR<135/85) | 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Job van Steenkiste, MD | Contact | +31631799089 | jobvansteenkiste@gmail.com | |
| Sjaam Jainandunsing, MD,PhD | Contact | jainandunsingS@maasstadziekenhuis.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maasstad Ziekenhuis | Recruiting | Rotterdam | South Holland | 3019DZ | Netherlands |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Other | Standard outpatient blood pressure management |
|
| 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 |
| 6 weeks, 6 months 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 | 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 |