HypertensionNCT06243978
Effectiveness of a Digital Health Application for Primary Hypertension (Liebria)
A study testing liebria and information brochure on hypertension in people with Hypertension, run by Gaia AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- liebria and information brochure on hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteGermany
- Study dates
- 2 Apr 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Home-based SBP > 180 mmHg
- > Triple combination of antihypertensive medication
- History of secondary hypertension (e.g., thyroid disease, kidney disease)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Digital Health Application for Primary Hypertension (Liebria): Randomized Controlled Trial
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.
Read the detailed description
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. Inclusion criteria are: age ≥ 18; presence of primary hypertension (confirmed by medical certificate or equivalent); 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 are: home-based SBP > 180 mmHg; > triple combination of antihypertensive medication; history of secondary hypertension (e.g., thyroid disease, kidney disease); pregnancy.
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
- Hypertension
- Being tested
- liebria, information brochure on hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liebriaBehavioural
Participants will receive access to the digital health intervention liebria in addition to TAU
information brochure on hypertensionOther
Participants will receive an information brochure on hypertension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: information brochure on hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Patient activation
Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).
Measured: 6 months
Social and work-related functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Measured: 6 months
Adherence to medication
Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).
Measured: 6 months
DBP (in mmHg)
DBP is 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.
Measured: 6 months
Pulse pressure (in mmHg)
Pulse pressure (PP) is 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start2 Apr 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Kamila Jauch-Chara, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243978
- Sponsor's protocol ID
- liebria RCT 2024
- Status last verified
- Jun 2026
- First submitted
- 17 Jan 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Health Application for Primary Hypertension (Liebria): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06243978
- Acronym / sponsor ID
- liebria RCT 2024
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, Charite University, Berlin, Germany
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Inclusion criteria are: age ≥ 18; presence of primary hypertension (confirmed by medical certificate or equivalent); 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 are: home-based SBP > 180 mmHg; > triple combination of antihypertensive medication; history of secondary hypertension (e.g., thyroid disease, kidney disease); pregnancy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liebria | Experimental | Behavioral: liebriaParticipants 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. |
| brochure on hypertension | Other | Other: information brochure on hypertensionParticipants allocated to the control group will receive a brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- Home-based SBP > 180 mmHg
- > Triple combination of antihypertensive medication
- History of secondary hypertension (e.g., thyroid disease, kidney disease)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liebriaParticipants will receive access to the digital health intervention liebria in addition to TAU | Behavioural | liebria |
| information brochure on hypertensionParticipants will receive an information brochure on hypertension | Other | brochure on hypertension |
Primary outcome
SBP (in mmHg)
Time frame: 6 months
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.
5 secondary outcomes
Patient activation
Time frame: 6 months
Social and work-related functioning
Time frame: 6 months
Adherence to medication
Time frame: 6 months
DBP (in mmHg)
Time frame: 6 months
Pulse pressure (in mmHg)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Jauch-Chara, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liebria and information brochure on hypertension in people with Hypertension, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBP (in mmHg) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.