Hypertension
Conditions
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.
Interventions
BEHAVIORALliebria
Participants will receive access to the digital health intervention liebria in addition to TAU
OTHERinformation brochure on hypertension
Participants will receive an information brochure on hypertension
Sponsors
Gaia AG
University Hospital Schleswig-Holstein
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SBP (in mmHg) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient activation | 6 months | Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome). |
| Social and work-related functioning | 6 months | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome). |
| Adherence to medication | 6 months | Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome). |
| DBP (in mmHg) | 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. |
| Pulse pressure (in mmHg) | 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. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORKamila Jauch-Chara, MD
University Hospital Schleswig-Holstein
Outcome results
None listed