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NCT Number: NCT06243978

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, Free and Hanseatic City of Hamburg, 22085, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

liebria

Behavioral

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

information brochure on hypertension

Other

Participants will receive an information brochure on hypertension

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient activation

    Time frame: 6 months

    Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).

  2. Social and work-related functioning

    Time frame: 6 months

    Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).

  3. Adherence to medication

    Time frame: 6 months

    Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).

  4. DBP (in mmHg)

    Time frame: 6 months

    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.

  5. Pulse pressure (in mmHg)

    Time frame: 6 months

    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.

Other outcomes

  1. Body Mass Index

    Time frame: 6 months, 3 months

    weight in kilograms and height in meters will be assessed and combined to report BMI in kg/m^2

  2. concomitant antihypertensive medication

    Time frame: 6 months, 3 months

    number and dosage of concomitant antihypertensive medications (agents in section C of the Anatomical Therapeutic Chemical Classification System)

  3. 24-hour average SBP (in mmHg)

    Time frame: 6 months, 3 months

    A 24-hour ambulatory blood pressure measurement (ABPM) will be performed according to recommendations of the International Society of Cardiology: ABPM will be conducted using an FDA-cleared, CE-labeled wireless, non-invasive chest-patch sensor for 24-hour, with measurements four times an hour over 24-hours, resulting in a total of 96 possible measurements.

  4. 24-hour average DBP (in mmHg)

    Time frame: 6 months, 3 months

    A 24-hour ambulatory blood pressure measurement (ABPM) will be performed according to recommendations of the International Society of Cardiology: ABPM will be conducted using an FDA-cleared, CE-labeled wireless, non-invasive chest-patch sensor for 24-hour, with measurements four times an hour over 24-hours, resulting in a total of 96 possible measurements.

  5. 24-hour average PP (in mmHg)

    Time frame: 6 months, 3 months

    A 24-hour ambulatory blood pressure measurement (ABPM) will be performed according to recommendations of the International Society of Cardiology: ABPM will be conducted using an FDA-cleared, CE-labeled wireless, non-invasive chest-patch sensor for 24-hour, with measurements four times an hour over 24-hours, resulting in a total of 96 possible measurements.

  6. Daytime average SBP (in mmHg)

    Time frame: 6 months, 3 months

    Daytime average SBP will be defined as the average of those ABPM measurements collected between 10:00 and 20:00, in agreement with the International Database of ABP in relation to Cardiovascular Outcome (IDACO) criteria for Europeans.

  7. Nighttime average SBP (in mmHg)

    Time frame: 6 months, 3 months

    Nighttime average SBP will be defined as the average of those ABPM measurements collected between 0:00 and 06:00, in agreement with the IDACO criteria for Europeans

  8. SBP (in mmHg)

    Time frame: 3 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.

  9. Patient activation

    Time frame: 3 months

    Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).

  10. Social and work-related functioning

    Time frame: 3 months

    Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).

  11. Adherence to medication

    Time frame: 3 months

    Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).

  12. DBP (in mmHg)

    Time frame: 3 months

    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.

  13. Pulse pressure (in mmHg)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • Charite University, Berlin, Germany
  • University Hospital Schleswig-Holstein

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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