Telemonitoring and E-Coaching in Hypertension
- Conditions
- Hypertension
- Interventions
- Other: Standard careOther: Home blood pressure monitoring (telemonitoring)
- Registration Number
- NCT05660226
- Lead Sponsor
- Maasstad Hospital
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Standard care Standard care in patients with hypertension Intervention Home blood pressure monitoring (telemonitoring) Home blood pressure monitoring + E-coaching
- Primary Outcome Measures
Name Time Method Hypertension control rate 6 months Percentage of patients with blood pressure on target (RR\<135/85)
- Secondary Outcome Measures
Name Time Method Self-management baseline and 6 months Self-efficacy to monitor blood pressure, effect of coaching on disease insight and skills using PAM 13 and EQ5DL questionnaires
Hospitalizations 6 months and 12 months Hospitalizations resulting from poor blood pressure control or cardiovascular complications resulting from poor blood pressure control (hypertensive emergencies, MI's, stroke)
Adverse cardiovascular events 6 months and 12 months Myocardial infarction, cerebrovascular events and hypertensive emergencies.
Hypertension control rate 6 weeks and 12 months Percentage of patients with blood pressure on target (RR\<140/90)
Direct Non-Medical Costs 6 weeks, 6 months and 12 months * 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 HBPTMedication use 6 weeks, 6 months and 12 months Biochemical assessment of antihypertensive medication concentrations in blood. Number of antihypertensive agents used at 6 months. Number of antihypertensive medication changes at 6 months.
Blood pressure control 6 weeks, 6 months and 12 months Mean systolic and diastolic blood pressures for both groups
Patient and Healthcare provider Satisfaction 6 months and 12 months Patients and health-care provider satisfaction as measured with TUQ and MAUQ questionnaires. The scales are from 1 to 7 (disagree to agree)
Indirect Non-Medical costs 6 weeks, 6 months and 12 months * 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)Indirect medical costs 6 weeks, 6 months and 12 months o Future unrelated medical costs (as calculated using the iMTA PAID module: costs related to other diseases due to improved life expectancy
Direct Medical Costs 6 weeks, 6 months and 12 months * 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
Trial Locations
- Locations (1)
Maasstad Ziekenhuis
🇳🇱Rotterdam, Zuid-Holland, Netherlands