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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243978
• Other study ID #: liebria RCT 2024
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: June 2024
• Source: Gaia AG
• Contact: Gitta A. Jacob, PhD
• Phone: +49.40.349930-374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Other:
• information brochure on hypertension
Participants will receive an information brochure on hypertension

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Charite University, Berlin, Germany, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	weight in kilograms and height in meters will be assessed and combined to report BMI in kg/m^2	6 months, 3 months
Other	concomitant antihypertensive medication	number and dosage of concomitant antihypertensive medications (agents in section C of the Anatomical Therapeutic Chemical Classification System)	6 months, 3 months
Other	24-hour average SBP (in mmHg)	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 months, 3 months
Other	24-hour average DBP (in mmHg)	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 months, 3 months
Other	24-hour average PP (in mmHg)	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 months, 3 months
Other	Daytime average SBP (in mmHg)	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.	6 months, 3 months
Other	Nighttime average SBP (in mmHg)	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	6 months, 3 months
Other	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.	3 months
Other	Patient activation	Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).	3 months
Other	Social and work-related functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).	3 months
Other	Adherence to medication	Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).	3 months
Other	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.	3 months
Other	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.	3 months
Primary	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	Patient activation	Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).	6 months
Secondary	Social and work-related functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).	6 months
Secondary	Adherence to medication	Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).	6 months
Secondary	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.	6 months
Secondary	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.	6 months