- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03018197
Use of Electronic Personal Health Records to Improve Medication Adherence
The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.
Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Indiana
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Fort Wayne, Indiana, Forente stater, 46845
- Parkview Research Center; Parkview Health
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Patient of Parkview Physicians Group-Cardiology
- Currently on dabigatran for non-valvular atrial fibrillation
- Out-patient status
- Ability to read and understand English
- Access to the Internet
- Ability to utilize the computer and Internet
- Willingness to enroll in a MyChart account
Exclusion Criteria:
- Physical or cognitive disability hindering provision of the informed consent process or performance of study tasks
- Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record
- Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- Currently part of another study involving another type of personal health record (other than MyChart)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
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Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran.
Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
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Ingen inngripen: No Medication Education
Patients will receive the current standard of care for the personal health record.
Patients will not receive training on the use of the personal health record or health education via the personal health record.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Medication Adherence evaluated through medication possession ratios
Tidsramme: 3 months during study
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3 months during study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Patient Engagement evaluated through Patient Activation Measure (PAM)
Tidsramme: 3 months during study
|
3 months during study
|
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Medication Knowledge evaluated through 5-question survey
Tidsramme: 3 months during study
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3 months during study
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael Mirro, MD, Parkview Health
- Hovedetterforsker: Ozlem Ersin, PhD, Manchester University College of Medicine
Studierekorddatoer
Studer hoveddatoer
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
- PRC13-0806 ePHR AFib pilot
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .