- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01826435
Improving Medication Adherence in Hypertensive Patients (HTNmobile)
24. januar 2014 opdateret af: Duke University
The study team is proposing a single arm intervention to test the effect of an electronic intervention on medication use among individuals with a prescription for hypertension/high blood pressure.
The investigator proposes that technology like text messaging, email, web applications and mobile apps with proven, nurse intervention scripts, will lead to significant, cost-effective improvements in hypertension medication use.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The intervention will incorporate a scalable electronic intervention using Email/Web Apps and Short Message Service (SMS)/Mobile Web Apps.
The study team will examine the participants' responses to the electronic encounters in the technology-only intervention throughout the 3-month study timeframe.
Undersøgelsestype
Interventionel
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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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Duke University Health System Clinic
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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
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Enrolled in the primary care clinic for the past 6 months
- New or existing prescription for hypertension
- Poorly controlled mean systolic blood pressure (SBP) in the last 12 months (>140/90 Hg)
Exclusion Criteria:
- Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 3 months,
- Diagnosis of metastatic cancer;
- Active diagnosis of psychosis or dementia documented in medical record;
- Does not have access to the appropriate technology required
- Is not willing to use said device to receive notifications for the study;
- Does not live independently (assisted living or nursing home residents) or otherwise institutionalized or receiving home health care
- Severely impaired hearing, vision or speech (unless technological aides allow them full functionality)
- Planning to leave the area or change primary care clinics prior to the anticipated end of participation;
- Unable to read and understand spoken English
- Participation in another cardiovascular disease (CVD) study
- Another household member enrolled in study;
- Arm size > 50cm
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Electronic Intervention
Over the three months, participants will receive a technology intervention.
This will include text or email encounter notifications associated with appropriate mobile or online self-management information for medication adherence and behavior change.
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Patients will be able to receive the intervention notifications over the electronic/multimedia mode they prefer; selecting either text messaging/mobile web and/or email/online web.
Text message or email alerts with an included uniform resource locator (URL) link to the specified mobile or online web site will be utilized to notify patients of a pending encounter available on mobile.
Topics that will be addressed in the intervention include medication and side effects, social support, hypertension knowledge, memory and smoking.
All intervention encounters that are designed to collect responses from the patient will require the patient to supply credentials before responding to the encounter; thus, ensuring privacy of the patient session, as well as patient-specific tracking of responses.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of Days Covered (PDC)
Tidsramme: 3 months
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Proportion of Days Covered (PDC), a Pharmacy Quality Alliance (PQA)-recommended metric for estimation of medication adherence for patients using chronic medications, will be used to identify the percentage of patients taking medications in a particular drug class with high adherence (PDC > 80% for the individual).
Participants with a PDC ≤0.8 will be categorized as having "poor" adherence, and those with a PDC >0.8 will be categorized as having "good" adherence.
For analyses, the PDC will be dichotomized at 0.8 (PDC >0.8) over the entire 3 month follow-up, yielding a single assessment of pill refill adherence that will be used as the primary outcome.
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. januar 2014
Primær færdiggørelse (Forventet)
1. august 2014
Studieafslutning (Forventet)
1. maj 2015
Datoer for studieregistrering
Først indsendt
4. april 2013
Først indsendt, der opfyldte QC-kriterier
4. april 2013
Først opslået (Skøn)
8. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00043793
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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