Clinical trial NCT02553512: Helius in Hypertension-I: The UK Hypertension Registry
Official title: Helius in Hypertension-I: The UK Hypertension Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Lead sponsor: Proteus Digital Health, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Frequency of Medication-taking (% Taking Adherence)
timeFrame: 2 weeks
measure: Pattern of Medication-taking (% Scheduling Adherence)
timeFrame: 2 weeks
Secondary outcomes:
measure: Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment
timeFrame: 2 weeks
measure: Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering
timeFrame: 2 weeks
measure: Blood Pressure Management After Use of Digital Health Offering
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: North Brink Practice, Cambridgeshire UK
name: Peter Godbehere, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.