N/A
N=167
Helius in Hypertension-I: The UK Hypertension Registry
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02553512 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Frequency of Medication-taking (% Taking Adherence) — 75 percentage of taking adherence
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ingestible Sensor and Wearable Sensor (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Proteus Digital Health, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Medication-taking (% Taking Adherence) |
75 | — |
| PRIMARY Pattern of Medication-taking (% Scheduling Adherence) |
65 | — |
| SECONDARY Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment |
32 | — |
| SECONDARY Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering |
9.7; 5.0 | — |
| SECONDARY Blood Pressure Management After Use of Digital Health Offering |
122; 19; 10 | — |
Summary
The purpose of this study is to demonstrate the use of a digital health offering in the management of persistent hypertension during chronic anti-hypertensive treatment.
Eligibility Criteria
Inclusion Criteria
- Male or female of age ≥ 18 years
- Essential hypertension, consisting of:
- Blood pressure ≥150 or ≥90 during chronic treatment with 2 or more drugs for patients ≥80 years of age; or,
- Blood pressure ≥140 or≥90) during chronic treatment with 2 or more drugs for patients <80 years of age
- Ability to read and understand the instructions for participating
- Capacity to read and to speak English proficiently
- Capacity to provide informed consent
Exclusion Criteria
- History of skin sensitivity to adhesive medical tape or metals
- History of acute or chronic dermatitis
- Any other condition that in the investigators opinion would compromise patient safety while participating
- Alcohol or other substance abuse
- Terminal illness
Data sourced from ClinicalTrials.gov (NCT02553512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.