Essential Hypertension
Conditions
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.
Interventions
OTHERIngestible Sensor and Wearable Sensor
This digital health offering passively acquires and records medication-taking and habits of daily living.
Sponsors
Proteus Digital Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Medication-taking (% Taking Adherence) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment | 2 weeks | Percentage of participants |
| Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering | 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 | 4 weeks | Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Helius Ingestible Sensor and Wearable Sensor | 151 |
| Total | 151 |
Baseline characteristics
| Characteristic | Helius |
|---|---|
| Age, Continuous | 68 Years STANDARD_DEVIATION 9 |
| Anti-Hypertensives (Class) ACE inhibitor | 82 Participants |
| Anti-Hypertensives (Class) Angiotensin receptor blocker | 57 Participants |
| Anti-Hypertensives (Class) Beta-blocker | 43 Participants |
| Anti-Hypertensives (Class) Calcium channnel antagonist | 93 Participants |
| Anti-Hypertensives (Class) Diuiretic | 72 Participants |
| Anti-Hypertensives (Class) Fixed-dose combination | 3 Participants |
| Anti-Hypertensives (Class) Other | 29 Participants |
| Anti-Hypertensives (Number) 1 | 0 Participants |
| Anti-Hypertensives (Number) 2 | 93 Participants |
| Anti-Hypertensives (Number) 3-5 | 58 Participants |
| Anti-Hypertensives (Type) Branded | 0 Participants |
| Anti-Hypertensives (Type) Generic | 136 Participants |
| Anti-Hypertensives (Type) Generic and Branded | 15 Participants |
| Blood Pressure Diastolic | 88 mm Hg |
| Blood Pressure Systolic | 154 mm Hg |
| Diabetes | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 151 Participants |
| Region of Enrollment United Kingdom | 151 Participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 151 |
| other Total, other adverse events | 18 / 151 |
| serious Total, serious adverse events | 0 / 151 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Helius | Frequency of Medication-taking (% Taking Adherence) | 75 percentage of taking adherence |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Helius | Pattern of Medication-taking (% Scheduling Adherence) | 65 percentage of scheduling adherence |
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)
Time frame: 4 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Helius | Blood Pressure Management After Use of Digital Health Offering | Meds review/Adherence counseling/no med changes | 122 Participants |
| Helius | Blood Pressure Management After Use of Digital Health Offering | Antihypertensive medication change | 19 Participants |
| Helius | Blood Pressure Management After Use of Digital Health Offering | No further action taken | 10 Participants |
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
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Helius | Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering | Systolic | 9.7 mm Hg |
| Helius | Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering | Diastolic | 5.0 mm Hg |
Secondary
Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment
Percentage of participants
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Helius | Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment | 32 percentage of participants |