Effectiveness of a digital health application for managing primary hypertension
Effectiveness of a Digital Health Application for Primary Hypertension (Liebria): Randomized Controlled Trial
NA · Gaia AG · NCT06243978
This study is testing if a new digital health app can help people with high blood pressure manage their condition better than just using a brochure with standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gaia AG (industry) |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06243978 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 328 patients with primary hypertension to evaluate the effectiveness of the self-guided digital application, liebria. Participants will be randomly assigned to either receive the application alongside standard treatment or a brochure from the German Hypertension League with standard treatment. The primary outcome will be measured by home-based systolic blood pressure after six months, with additional assessments at three months. The study aims to enhance patient engagement and improve hypertension management through digital health tools.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed primary hypertension who are either unmedicated or on stable antihypertensive therapy.
Not a fit: Patients with secondary hypertension, those on multiple antihypertensive medications, or with severely elevated blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with a more effective and engaging way to manage their hypertension.
How similar studies have performed: Other studies have shown promise in using digital health applications for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Presence of primary hypertension, confirmed by submission of a medical certificate or equivalent (e.g., informal letter signed by primary care physician); relevant ICD-10-GM diagnoses: * I10.00 (Benign essential hypertension: Without indication of hypertensive crisis) * I10.90 (Essential hypertension, unspecified: Without indication of hypertensive crisis) * Unmedicated or with existing antihypertensive drug therapy (with stable dose in the past 6 weeks prior to study enrolment) * Last reported office-based systolic blood pressure (SBP) ≥ 140 mmHg followed by home-based SBP ≥ 135 mmHg * Consent to participate Exclusion Criteria: * Home-based SBP \> 180 mmHg * \> Triple combination of antihypertensive medication * History of secondary hypertension (e.g., thyroid disease, kidney disease) * Pregnancy
Where this trial is running
Hamburg
- GAIA AG — Hamburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Kamila Jauch-Chara, MD — University Hospital Schleswig-Holstein
- Study coordinator: Gitta A. Jacob, PhD
- Email: gitta.jacob@gaia-group.com
- Phone: +49.40.349930-374
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.
Conditions: Hypertension