- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00277381
Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology
27. februar 2013 opdateret af: Joseph C. Kvedar, Massachusetts General Hospital
Treating hypertension is known to decrease morbidity and mortality.
Despite this 70% of patients do not have adequately controlled blood pressure.
The main reason for this is non-adherence to recommended drug therapy.
Although strategies have been developed to improve adherence many are time consuming and expensive.
We propose to use communications technology to develop a novel means of improving adherence to antihypertensive therapy.
We will conduct a randomised, single-blinded, controlled study to assess the impact of a real-time, automated reminder system on adherence rates.
This will involve adapting two pieces of currently available technology - the electronic pill bottle and the Ambient Globe.
The Globe will change colour in response to information received, via a wireless link, from the patient's electronic pill bottle.
We hypothesise that this will provide patients with an up to date, but unobtrusive, reminder of their adherence status and thus effect positive behavioural change.
We will measure the impact of this intervention on adherence rates as well as assessing patient views and the impact on provider workload.
This trial will elucidate the role of communications technology in improving adherence behaviour and allow us to develop further strategies to tackle this major health issue.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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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
45 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Prescription of a once-a-day dose of atenolol.
- Morisky Score of less than or equal to 2 (explanation in 'Equitable Selection of Subjects').
- Fluency in English.
- Age 45-65 inclusive.
- Primary Care Physician consent to the patient taking part.
Exclusion Criteria:
- Patients prescribed more than two anti-hypertensive agents.
- Patients prescribed more than four medications in total.
- Patients on secondary prevention following cardiac event or stroke.
- Morisky Score of more than 2.
- Patients with visual impairment or color-blindness.
- Patients with congenital or acquired cognitive impairment.
- Patients with a cardiac pacemaker
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Adherence rates as measured using data held in the SIMpill database
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Patient satisfaction with intervention as assessed by questionnaire at the end of the study.
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Technical difficulties as assessed by interview at the end of the study and by review of the technical log.
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Sekundære resultatmål
Resultatmål |
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Discontinuation rates of medication as assessed at the end of trial debrief.
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Changes to medication regime as assessed at the end of trial debrief.
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Adverse events (e.g. hospitalisation) as assessed from the log of withdrawals from the trial.
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Blood pressure as measured on enrollment and at end of trial debrief.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Joseph C. Kvedar, MD, Partners Healthcare System
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. juli 2006
Primær færdiggørelse (Faktiske)
1. januar 2008
Studieafslutning (Faktiske)
1. januar 2008
Datoer for studieregistrering
Først indsendt
13. januar 2006
Først indsendt, der opfyldte QC-kriterier
13. januar 2006
Først opslået (Skøn)
16. januar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. marts 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. februar 2013
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2005-P-002248
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 .
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