Helius in Hypertension-I: The UK Hypertension Registry

Essential Hypertension Clinical Trial

Official title:

Helius in Hypertension-I: The UK Hypertension Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553512
• Other study ID #: PB-HELIUS
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: September 16, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Proteus Digital Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Proteus Digital Health, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of medication-taking (% timing 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	No
Primary	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	No
Secondary	Proportion of patients capable of achieving blood pressure control on existing treatment		2 weeks	No
Secondary	Change in systolic and diastolic blood pressure after use of digital health offering	Change in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline	2 weeks	No
Secondary	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	No