Helius in Hypertension-I: The UK Hypertension Registry

Completed

Conditions: Essential Hypertension

Registration Number: NCT02553512

Lead Sponsor: Proteus Digital Health, Inc.

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

Inclusion Criteria

Male or female of age ≥ 18 years
Essential hypertension, consisting of:
1. Blood pressure ≥150 or ≥90 during chronic treatment with 2 or more drugs for patients ≥80 years of age; or,
2. 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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of Medication-taking (% Taking Adherence)	2 weeks	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.
Pattern of Medication-taking (% Scheduling Adherence)	2 weeks	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.

Secondary Outcome Measures

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