Helius in Hypertension-I: The UK Hypertension Registry

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Other: Ingestible Sensor and Wearable Sensor

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.

• Study Type: Observational
• Enrollment (Actual): 151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having blood pressure (measured in mm Hg) ≥150 systolic or ≥90 diastolic during chronic treatment with 2 or more anti-hypertensive drugs, and age ≥80 years; or blood pressure ≥140 systolic or ≥90 diastolic during chronic treatment with 2 or more anti-hypertensive, and <80 years

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Proteus Digital Health, Inc.
• Investigators: Principal Investigator: Peter Godbehere, MD, North Brink Practice, Cambridgeshire UK

Publications and helpful links

General Publications

• Godbehere P, Wareing P. Hypertension assessment and management: role for digital medicine. J Clin Hypertens (Greenwich). 2014 Mar;16(3):235. doi: 10.1111/jch.12246. Epub 2014 Feb 5. No abstract available.

Helpful Links

• Naik R, Macey N, West RJ, Godbehere P, Thurston SC, et al. (2017) UK Hypertension Registry (Study Results--Full Manuscript). J Community Med Health Educ 7: 506. doi:10.4172/2161-0711.1000506

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: PB-HELIUS