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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingestible Sensor and Wearable Sensor | Other | This digital health offering passively acquires and records medication-taking and habits of daily living. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment | Percentage of participants | 2 weeks |
| Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering |
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Inclusion Criteria:
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
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Peter Godbehere, MD | North Brink Practice, Cambridgeshire UK | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24498940 | Background | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Helius | Ingestible Sensor and Wearable Sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Helius | Ingestible Sensor and Wearable Sensor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | percentage of taking adherence | 2 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Helius | Ingestible Sensor and Wearable Sensor | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
This was an open-label registry. Patients may have increased their adherence due to a Hawthorne effect. Patients may have been selective in the medications that they actually ingested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo DiCarlo MD, Vice-President of Clinical and Medical Affairs | Proteus Digital Health | +1 650 637 6199 | ldicarlo@proteus.com |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline
| 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) | 4 weeks |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Blood Pressure | Mean | Full Range | mm Hg |
|
| Diabetes | Count of Participants | Participants |
|
| Anti-Hypertensives (Type) | Count of Participants | Participants |
|
| Anti-Hypertensives (Number) | Count of Participants | Participants |
|
| Anti-Hypertensives (Class) | Count of Participants | Participants |
|
|
| Primary | 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. | Posted | Median | Full Range | percentage of scheduling adherence | 2 weeks |
|
|
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| Secondary | Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment | Percentage of participants | Posted | Number | percentage of participants | 2 weeks |
|
|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | mm Hg | 2 weeks |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 151 |
| 0 |
| 151 |
| 18 |
| 151 |
| Gastrointestinal complaint | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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