Helius in Hypertension-I: The UK Hypertension Registry

• ClinicalTrials.gov Identifier: NCT02553512
• Recruitment Status: Completed
• First Posted: September 17, 2015
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Sponsor: Proteus Digital Health, Inc.
• Information provided by (Responsible Party): Proteus Digital Health, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Essential Hypertension	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 151 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Weeks
• Official Title: Helius in Hypertension-I: The UK Hypertension Registry
• Study Start Date: September 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: May 2015

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Frequency of Medication-taking (% Taking Adherence) [ Time Frame: 2 weeks ]
   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. Pattern of Medication-taking (% Scheduling Adherence) [ Time Frame: 2 weeks ]
   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.

Secondary Outcome Measures :

1. Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment [ Time Frame: 2 weeks ]
   Percentage of participants
2. Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering [ Time Frame: 2 weeks ]
   Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline
3. Blood Pressure Management After Use of Digital Health Offering [ Time Frame: 4 weeks ]
   Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist)

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

Proteus Digital Health, Inc.

Investigators

• Principal Investigator: Peter Godbehere, MD; North Brink Practice, Cambridgeshire UK

More Information

Additional Information:

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.

• Responsible Party: Proteus Digital Health, Inc.
• ClinicalTrials.gov Identifier: NCT02553512 History of Changes
• Other Study ID Numbers: PB-HELIUS
• First Posted: September 17, 2015
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Last Verified: April 2017

Additional relevant MeSH terms:

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases