Helius in Hypertension-I: The UK Hypertension Registry
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of Medication-taking (% Taking Adherence)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment
Tidsramme: 2 weeks
|
Percentage of participants
|
2 weeks
|
|
Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Peter Godbehere, MD, North Brink Practice, Cambridgeshire UK
Publikasjoner og nyttige lenker
Generelle publikasjoner
Studierekorddatoer
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Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PB-HELIUS
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