Hypertension
Conditions
Keywords
Blood pressure, Digital health intervention
Brief summary
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.
Detailed description
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
Interventions
OTHERElfie Solution
The Elfie solution was designed to improve knowledge, adherence, and the quality of care for patients with cardiovascular diseases. The Elfie solution comprises a mobile phone app with the following features related to hypertension: 1. Personalized monitoring plan based on health conditions to guide frequency of monitoring of blood pressure, weight, and step count 2. Digital pillbox with daily medication-taking reminders and refill reminders 3. Clinical measurements graphs for BP, weight, medical adherence and step count 4. Newsfeed with short videos and texts related to cardiovascular diseases 5. Digital coach - Artificial intelligence technology that provides information via a chatbox as well as feedback information via personalized videos. This feature does not provide medical advice. 6. Connection with a health app or wearable for step count 7. Possibility of family peer support 8. Gamification through the Elfie rewards scoring system
Sponsors
Hospital Israelita Albert Einstein
Elfie Pte. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be instructed not to mention their allocated group to the outcome assessor until the end of the follow-up visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Office systolic blood pressure (SBP) | 6-months | Mean systolic blood pressure, calculated as the average of the second and third readings obtained from three consecutive measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of participants achieving office SBP < 140mmHg | 6-months | Percentage (%) of participants achieving office SBP \< 140mmHg |
| Percentage (%) of participants achieving office SBP < 130mmHg | 6-months | Percentage (%) of participants achieving office SBP \< 130mmHg |
| Office diastolic blood pressure (DBP) | 6-months | Mean diastolic blood pressure, calculated as the average of the second and third readings obtained from three consecutive measurements. |
| Percentage (%) participants achieving DBP < 90mmHg | 6-months | Percentage (%) participants achieving DBP \< 90mmHg |
| Percentage (%) participants achieving DBP < 80mmHg | 6-months | Percentage (%) participants achieving DBP \< 80mmHg |
| Anti-hypertensive treatment intensification | 6-months | Any anti-hypertensive treatment intensification (increase in dose or number of agents) |
| Body mass index | 6-months | Mean body mass index |
| Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication | 6-months | 8-item Morisky Medication Adherence Scale (MMAS) |
| Level of hypertension knowledge measured by the Hypertension Knowledge-level scale | 6-months | Hypertension Knowledge-level scale (HK-LS) |
| Level of hypertension-related self-care measured by the Self-care of Hypertension | 6-months | Self-care of Hypertension Inventory (SC-HI) |
| Quality of life measured by the SF-12 questionnaire | 6-months | SF-12 questionnaire |
| CV-related unscheduled visits to the doctor's office or emergency room | 6-months | Number of unscheduled visits |
Countries
Brazil, Vietnam
Contacts
PRINCIPAL_INVESTIGATORKarla Santo, MD, Phd
karla.santo@einstein.br
Outcome results
None listed