Clinical trial NCT06243978: Effectiveness of a Digital Health Application for Primary Hypertension (Liebria)
Official title: Effectiveness of a Digital Health Application for Primary Hypertension (Liebria): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
name: Charite University, Berlin, Germany
First posted: 2024-02-06
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SBP (in mmHg)
timeFrame: 6 months
Secondary outcomes:
measure: Patient activation
timeFrame: 6 months
measure: Social and work-related functioning
timeFrame: 6 months
measure: Adherence to medication
timeFrame: 6 months
measure: DBP (in mmHg)
timeFrame: 6 months
measure: Pulse pressure (in mmHg)
timeFrame: 6 months
Other outcomes:
measure: Body Mass Index
timeFrame: 6 months, 3 months
measure: concomitant antihypertensive medication
timeFrame: 6 months, 3 months
measure: 24-hour average SBP (in mmHg)
timeFrame: 6 months, 3 months
measure: 24-hour average DBP (in mmHg)
timeFrame: 6 months, 3 months
measure: 24-hour average PP (in mmHg)
timeFrame: 6 months, 3 months
measure: Daytime average SBP (in mmHg)
timeFrame: 6 months, 3 months
measure: Nighttime average SBP (in mmHg)
timeFrame: 6 months, 3 months
measure: SBP (in mmHg)
timeFrame: 3 months
measure: Patient activation
timeFrame: 3 months
measure: Social and work-related functioning
timeFrame: 3 months
measure: Adherence to medication
timeFrame: 3 months
measure: DBP (in mmHg)
timeFrame: 3 months
measure: Pulse pressure (in mmHg)
timeFrame: 3 months
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Kamila Jauch-Chara, MD
role: PRINCIPAL_INVESTIGATOR
References: