Helius in Hypertension-I: The UK Hypertension Registry

NCT ID: NCT02553512

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 151 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Essential Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ingestible Sensor and Wearable Sensor

This digital health offering passively acquires and records medication-taking and habits of daily living.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Proteus Digital Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Godbehere, MD

Role: PRINCIPAL_INVESTIGATOR

North Brink Practice, Cambridgeshire UK

References

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.

Reference Type: BACKGROUND

PMID: 24498940 (View on PubMed)

Other Identifiers

PB-HELIUS

Identifier Type: -

Identifier Source: org_study_id