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Helius in Hypertension-I: The UK Hypertension Registry

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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:
Information provided by (Responsible Party):
Proteus Digital Health, Inc.

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553512


Sponsors and Collaborators
Proteus Digital Health, Inc.
Investigators
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Principal Investigator: Peter Godbehere, MD North Brink Practice, Cambridgeshire UK
More Information
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Additional Information:
Naik R, Macey N, West RJ, Godbehere P, Thurston SC, et al. (2017) UK Hypertension Registry (Study Results--Full Manuscript). J Community Med Health Educ 7: 506. doi:10.4172/2161-0711.1000506  This link exits the ClinicalTrials.gov site

Publications:

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

Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases