Helius in Hypertension-I: The UK Hypertension Registry

NCT02553512 | Completed Results

• 1 other identifier: PB-HELIUS
• Study Type: observational
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment

  2 weeks

• Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering

  2 weeks

• Blood Pressure Management After Use of Digital Health Offering

  4 weeks

Interventions

Ingestible Sensor and Wearable Sensor OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Proteus Digital Health, Inc.: lead

Related 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. No abstract available.

  PMID: 24498940 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This was an open-label registry. Patients may have increased their adherence due to a Hawthorne effect. Patients may have been selective in the medications that they actually ingested.

Results Point of Contact

• Title: Lorenzo DiCarlo MD, Vice-President of Clinical and Medical Affairs
• Organization: Proteus Digital Health

ldicarlo@proteus.com

+1 650 637 6199

Study Officials

• Peter Godbehere, MD

  North Brink Practice, Cambridgeshire UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-04