Essential HypertensionNCT02553512
Helius in Hypertension-I: The UK Hypertension Registry
An observational study of Essential Hypertension, run by Proteus Digital Health, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Ingestible Sensor and Wearable Sensor
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to May 2015
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Ingestible Sensor and Wearable Sensor
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestible Sensor and Wearable SensorOther
This digital health offering passively acquires and records medication-taking and habits of daily living.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (3)
Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment
Percentage of participants
Measured: 2 weeks
Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering
Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline
Measured: 2 weeks
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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Proteus Digital Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Godbehere, MD, Principal investigator, North Brink Practice, Cambridgeshire UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553512
- Sponsor's protocol ID
- PB-HELIUS
- Status last verified
- Apr 2017
- First submitted
- 15 Sep 2015
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. No abstract available.
PubMed 24498940
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helius in Hypertension-I: The UK Hypertension Registry
- ClinicalTrials.gov ID
- NCT02553512
- Acronym / sponsor ID
- PB-HELIUS
- Conditions
- Essential Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Proteus Digital Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Male or female of age ≥ 18 years
- Essential hypertension, consisting of:
- Ability to read and understand the instructions for participating
- Capacity to read and to speak English proficiently
- Capacity to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestible Sensor and Wearable SensorThis digital health offering passively acquires and records medication-taking and habits of daily living. | Other | – |
Primary outcome
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.
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.
3 secondary outcomes
Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment
Time frame: 2 weeks
Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering
Time frame: 2 weeks
Blood Pressure Management After Use of Digital Health Offering
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24498940Godbehere 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.
- 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:10.4172/2161-0711.1000506Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Godbehere, MD principal investigator
North Brink Practice, Cambridgeshire UK
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by Proteus Digital Health, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Medication-taking (% Taking Adherence) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.