RecruitingNot ApplicableNCT06243978

Effectiveness of a Digital Health Application for Primary Hypertension (Liebria)

Effectiveness of a Digital Health Application for Primary Hypertension (Liebria): Randomized Controlled Trial


Sponsor

Gaia AG

Enrollment

328 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • Home-based SBP \> 180 mmHg
  • \> Triple combination of antihypertensive medication
  • History of secondary hypertension (e.g., thyroid disease, kidney disease)
  • Pregnancy

Interventions

BEHAVIORALliebria

Participants will receive access to the digital health intervention liebria in addition to TAU

OTHERinformation brochure on hypertension

Participants will receive an information brochure on hypertension


Locations(1)

GAIA AG

Hamburg, Germany

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NCT06243978


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