Hypertension
Conditions
Brief summary
The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).
Interventions
None listed
Sponsors
Lindus Health
Aktiia SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Adult participants aged 22 to 85 years old 2. A participant whose last blood pressure reading was within the last 12 months and was either: 1. SBP ≥145 2. or ≥DBP 90 3. People who use either an iOS or Android smartphone 4. People who have 2 arms 5. Able and willing to provide informed consent and to adhere to study procedures.
Exclusion criteria
1. Participants whose BP data submitted is \>180 mm Hg systolic OR \>120 mm Hg diastolic . 2. Participants with a self-reported known diagnosis of 1. atrial fibrillation 2. congestive heart failure 3. heart valve disease 4. pheochromocytoma 5. Raynaud's disease 6. arm lymphedema 3. Participants who take insulin 4. Participants who are on hemodialysis 5. Women who are self-reported to be pregnant 6. Participants whose arms shake uncontrollably or are paralyzed (cannot move) 7. Participants with upper arm circumference \<22 cm or \>42 cm 8. Participants with wrist circumference \>23cm 9. Participation in another interventional clinical study or use of investigational drugs in the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure evolution over 12 weeks | 3 months | Means, medians, standard deviations, and ranges for Blood Pressure readings and changes in Blood Pressure readings within the study population between week 1 to week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor | 3 months | Number of participants with preferences using Aktiia 24/7 device, as copared to Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor to monitor their blood pressure. |
| Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors. | 3 months | Statistics on a potential correlation between Blood Pressure measurements and subjects responses to questionnaires regarding their lifestyle, socioeconomic environment and general health. |
Countries
United Kingdom
Outcome results
None listed