Helius in Hypertension-I: The UK Hypertension Registry
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of Medication-taking (% Taking Adherence)
時間枠：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.
|
2 weeks
|
|
Pattern of Medication-taking (% Scheduling Adherence)
時間枠：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.
|
2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment
時間枠：2 weeks
|
Percentage of participants
|
2 weeks
|
|
Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering
時間枠：2 weeks
|
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
時間枠：4 weeks
|
Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist)
|
4 weeks
|
協力者と研究者
捜査官
- 主任研究者：Peter Godbehere, MD、North Brink Practice, Cambridgeshire UK
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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