The ELFIE-HYPERTENSION Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 930
- 试验地点
- 16
- 主要终点
- Office systolic blood pressure (SBP)
研究概览
简要总结
The ELFIE-HYPERTENSION randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the Elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension.
详细描述
The ELFIE-HYPERTENSION randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the Elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension. The study will also evaluate whether this digital health intervention compared to usual care will improve diastolic blood pressure, adherence to anti-hypertensive medication, anti-hypertensive treatment intensification, body mass index, hypertension knowledge, self-care, quality of life, and the need for unscheduled cardiovascular-related medical assessment.
The hypothesis is that the Elfie solution will improve blood pressure control in individuals with hypertension
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
- Single (Outcomes Assessor)
盲法说明
Participants will be instructed not to mention their allocated group to the outcome assessor until the end of the follow-up visit.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years
- •Male and female patients
- •Hypertension diagnosis based on the local guidelines criteria
- •Uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg) on the screening visit
- •Patients in whom medication adherence needs to be improved according to the healthcare provider clinical judgment
- •Use of at least 1 anti-hypertensive medication
- •Ownership of an active smartphone with operational system iOS (version 13.0 or later) or Android (version 8.0 or later) with access to the internet on 3G, 4G or 5G
- •Ability to use a smartphone app
排除标准
- •Refusal to provide written informed consent
- •Current use of a health app with the aim to improve medication adherence and blood pressure control
- •Illiteracy to read in the local language
- •Known cognitive decline, dementia, or diagnosis of severe psychiatric conditions (depression, schizophrenia, bipolar disorder)
- •Known use of illicit drugs or alcoholism
- •Current participation in a cardiovascular randomized clinical trial
- •Life expectancy < 1 year
研究组 & 干预措施
Usual care group
Patients randomized to usual care will receive standard care, in which hypertension treatment will be provided according to local practices and will not have access to the Elfie solution. Additionally, they will be requested not to access/use other mobile phone apps or participate in any kind of digital health intervention related to hypertension treatment during the trial.
Digital health intervention group (Elfie solution)
Patients randomized to digital health intervention group will receive standard care plus the Elfie solution. Participants randomized to the Elfie solution will be instructed to download the Elfie app and will receive training on how to register in the app and on how to use all the app features. Participants will be then instructed to use the app according to the monitoring plan created by the app for the following 6 months.
干预措施: Elfie Solution (Other)
结局指标
主要结局
Office systolic blood pressure (SBP)
时间窗: 6-months
Mean systolic blood pressure, calculated as the average of the second and third readings obtained from three consecutive measurements.
次要结局
- Body mass index(6-months)
- Quality of life measured by the SF-12 questionnaire(6-months)
- Percentage (%) participants achieving DBP < 90mmHg(6-months)
- Percentage (%) of participants achieving office SBP < 130mmHg(6-months)
- Level of hypertension knowledge measured by the Hypertension Knowledge-level scale(6-months)
- Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication(6-months)
- Percentage (%) of participants achieving office SBP < 140mmHg(6-months)
- Percentage (%) participants achieving DBP < 80mmHg(6-months)
- Level of hypertension-related self-care measured by the Self-care of Hypertension(6-months)
- CV-related unscheduled visits to the doctor's office or emergency room(6-months)
- Office diastolic blood pressure (DBP)(6-months)
- Anti-hypertensive treatment intensification(6-months)