Telemonitoring and E-Coaching for managing hypertension
Telemonitoring and E-Coaching in Hypertension
This study tests if using a smartphone app for tracking blood pressure along with personal coaching can help adults with high blood pressure manage their condition better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maasstad Hospital Academic / other |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT05660226 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a telemonitoring approach combined with a personal counseling program for adults with hypertension. Participants will use a smartphone application for self-monitoring their blood pressure and receive automated services aimed at improving medication adherence and lifestyle changes. The study compares this intervention to standard care to determine its impact on hypertension control rates and overall health care costs. The trial is designed as a non-blinded randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hypertension who can use a smartphone or have support for technical assistance.
Not a fit: Patients with severe kidney disease, recent cardiovascular events, or those currently using specific blood pressure monitoring apps may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hypertension management and reduce healthcare costs for patients.
How similar studies have performed: Other studies have shown promising results with telemonitoring approaches for hypertension management, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rotterdam, Zuid-Holland
- Maasstad Ziekenhuis — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Job van Steenkiste, MD
- Email: jobvansteenkiste@gmail.com
- Phone: +31631799089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.