Effectiveness of a Digital Health Application for Primary Hypertension (Liebria)
NCT ID: NCT06243978
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
328 participants
INTERVENTIONAL
2024-04-02
2025-04-15
Brief Summary
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Detailed Description
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Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to liebria in addition to treatment as usual (TAU, n = 164), or to a control group, in which they will receive a relevant brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU (n = 164). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e. g. cardiologist).
The primary endpoint will be home-based SBP, with 6 months post-allocation being the primary time point for assessment of effectiveness. Three months post-allocation will be used as an additional endpoint. Secondary endpoints will be patient activation, social and work-related functioning, medication adherence, home-based diastolic blood pressure (DBP), and pulse pressure.
Analysis of effectiveness of the intervention will be performed by ANCOVA of the primary endpoint and all secondary endpoints, in which the posttreatment scores will be compared between treatment groups (intervention group vs. control group), using the baseline scores of the respective outcome as a covariate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
liebria
Participants will receive access to the digital health intervention liebria in addition to TAU
brochure on hypertension
Participants allocated to the control group will receive a brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU.
information brochure on hypertension
Participants will receive an information brochure on hypertension
Interventions
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liebria
Participants will receive access to the digital health intervention liebria in addition to TAU
information brochure on hypertension
Participants will receive an information brochure on hypertension
Eligibility Criteria
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Inclusion Criteria
* 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
* \> Triple combination of antihypertensive medication
* History of secondary hypertension (e.g., thyroid disease, kidney disease)
* Pregnancy
18 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Charite University, Berlin, Germany
OTHER
Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Kamila Jauch-Chara, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Locations
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GAIA AG
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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liebria RCT 2024
Identifier Type: -
Identifier Source: org_study_id
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