Helius in Hypertension-I: The UK Hypertension Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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In patients with persistent essential systolic hypertension,who are undergoing assessment of their current pharmaceutical burden for blood pressure control, a digital health offering is used (1) to provide automatic and passive electronic documentation of medication adherence and patterns of medication taking, (2) to assist providers in distinguishing inadequate medication adherence or pharmacologic unresponsiveness as the root cause for persistent hypertension, and (3) to inform management decisions (dose adjustment, medication addition or substitution, adherence counseling, referral to a hypertension specialist). Participating patients wear an adhesive Wearable Sensor (Patch) continuously with replacement after one week, and ingest an inert tablet (Pill) containing an Ingestible Sensor daily whenever they take their prescribed anti-hypertensive drugs. The Patch automatically detects and records the dates and times of each Pill ingestion, daily step count, sleep duration and sleep interruptions, and the circadian pattern of rest and activity. After completion of each Patch's use, the recorded data are downloaded and incorporated into a report that includes blood pressures that are obtained at the time of clinic visits at the beginning and after 2 weeks of service use. The final report is generated automatically and provided electronically to practitioners for review with their patient. The information that is obtained is incorporated by practitioners in advising next steps for blood pressure management.

Official Title
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Helius in Hypertension-I: The UK Hypertension Registry

Conditions
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Essential Hypertension

Intervention / Treatment
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* Other: Ingestible Sensor and Wearable Sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ingestible Sensor and Wearable Sensor|This digital health offering passively acquires and records medication-taking and habits of daily living.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Medication-taking (% Taking Adherence) | Percent timing adherence is determined by the number of ingestion sensors detected by the wearable monitor, divided by the total number of ingestion sensors prescribed, for the 2 week-time frame. | 2 weeks | 
| Pattern of Medication-taking (% Scheduling Adherence) | Percent scheduling adherence is determined by the number of ingestion sensors detected within a ± 2-hour time window around the prescribed dosing period, divided by the number of ingestion sensors detected by the wearable sensor during that dosing period, over the 2-week time frame. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment | Percentage of participants | 2 weeks | 
| Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering | Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline | 2 weeks | 
| Blood Pressure Management After Use of Digital Health Offering | Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist) | 4 weeks |