NCT06243978

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 2, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

January 17, 2024

Last Update Submit

June 18, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • SBP (in mmHg)

    The primary endpoint is SBP collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.

    6 months

Secondary Outcomes (5)

  • Patient activation

    6 months

  • Social and work-related functioning

    6 months

  • Adherence to medication

    6 months

  • DBP (in mmHg)

    6 months

  • Pulse pressure (in mmHg)

    6 months

Other Outcomes (13)

  • Body Mass Index

    6 months, 3 months

  • concomitant antihypertensive medication

    6 months, 3 months

  • 24-hour average SBP (in mmHg)

    6 months, 3 months

  • +10 more other outcomes

Study Arms (2)

liebria

EXPERIMENTAL

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.

Behavioral: liebria

brochure on hypertension

OTHER

Participants allocated to the control group will receive a brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU.

Other: information brochure on hypertension

Interventions

liebriaBEHAVIORAL

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

liebria
information brochure on hypertensionOTHER

Participants will receive an information brochure on hypertension

brochure on hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GAIA AG

Hamburg, 22085, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kamila Jauch-Chara, MD

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitta A. Jacob, PhD

CONTACT

+49.40.349930-374gitta.jacob@gaia-group.com

Antje Riepenhausen, PhD

CONTACT

antje.riepenhausen@gaia-group.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 6, 2024

Study Start

April 2, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)