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Helius in Hypertension-I: The UK Hypertension Registry

3. april 2017 opdateret af: Proteus Digital Health, Inc.
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

151

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Proteus Digital Health, Inc.

Efterforskere

  • Ledende efterforsker: Peter Godbehere, MD, North Brink Practice, Cambridgeshire UK

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

15. september 2015

Først indsendt, der opfyldte QC-kriterier

16. september 2015

Først opslået (Skøn)

17. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PB-HELIUS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Essentiel hypertension

Kliniske forsøg med Ingestible Sensor and Wearable Sensor

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bulgaria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner