Helius in Hypertension-I: The UK Hypertension Registry
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| ClinicalTrials.gov Identifier: NCT02553512 |
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Recruitment Status :
Completed
First Posted : September 17, 2015
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Essential Hypertension | Other: Ingestible Sensor and Wearable Sensor |
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 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 |
- Other: Ingestible Sensor and Wearable Sensor
This digital health offering passively acquires and records medication-taking and habits of daily living.
- 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.
- Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment [ Time Frame: 2 weeks ]Percentage of participants
- 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
- 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)
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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 |
Inclusion Criteria:
- Male or female of age ≥ 18 years
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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
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
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
| Principal Investigator: | Peter Godbehere, MD | North Brink Practice, Cambridgeshire UK |
Publications:
| Responsible Party: | Proteus Digital Health, Inc. |
| ClinicalTrials.gov Identifier: | NCT02553512 |
| 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 |
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Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases |