NCT02553512

Helius in Hypertension-I: The UK Hypertension Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 151 (actual)
• Sponsor: Proteus Digital Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
OTHER	Ingestible Sensor and Wearable Sensor	This digital health offering passively acquires and records medication-taking and habits of daily living.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2015-09-17
• Last updated: 2017-06-16
• Results posted: 2017-06-16