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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
GAIA AG
RECRUITING
Hamburg
Contact Information
Primary
Gitta A. Jacob, PhD
gitta.jacob@gaia-group.com
+49.40.349930-374
Backup
Antje Riepenhausen, PhD
antje.riepenhausen@gaia-group.com
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2025-04-15
Participants
Target number of participants: 328
Treatments
Experimental: liebria
Participants allocated to the intervention group will receive access to liebria in addition to treatment as usual (TAU).~reviga is a digital health application designed for individuals with hypertension, accessible through a web browser. The application focuses on evidence-based psychological and psychotherapeutic methods combined with psychoeducation and health behavior change. Topics addressed by liebria include clarifying and strengthening motivation, training the parasympathetic nervous system, recognizing and overcoming obstacles, strengthening impulse control, development of an individualized day plan, and relapse prevention.~The program operates through interactive dialogues, which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 360 days.
Other: brochure on hypertension
Participants allocated to the control group will receive a brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU.
Related Therapeutic Areas
Sponsors
Leads: Gaia AG
Collaborators: Charite University, Berlin, Germany, University Hospital Schleswig-Holstein

This content was sourced from clinicaltrials.gov