Effectiveness of a Digital Health Application for Primary Hypertension (Liebria): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Gaia AG
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- SBP (in mmHg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Home-based SBP > 180 mmHg
- •> Triple combination of antihypertensive medication
- •History of secondary hypertension (e.g., thyroid disease, kidney disease)
- •Pregnancy
研究组 & 干预措施
liebria
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.
干预措施: liebria (Behavioral)
brochure on hypertension
Participants allocated to the control group will receive a brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU.
干预措施: information brochure on hypertension (Other)
结局指标
主要结局
SBP (in mmHg)
时间窗: 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.
次要结局
- Patient activation(6 months)
- DBP (in mmHg)(6 months)
- Pulse pressure (in mmHg)(6 months)
- Social and work-related functioning(6 months)
- Adherence to medication(6 months)