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Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia

15. april 2019 oppdatert av: Rebecca Dillingham, MD/MPH, University of Virginia

Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia - Pilot Study

The purpose of this study is to pilot a mobile health intervention, originally designed for HIV retention in care, for use in aiding patients with medication refills. The study will implement the PositiveLinks Rx app with the Henrico Health department. The study will assess user engagement and satisfaction with the app as well as preliminary impact on patient refill compliance.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study will enrolled provider and patient participants at the Henrico Health Department in Virginia who either receive or provide medication refills through the AIDS Drug Assistance Program (ADAP). Patient participants will be provided access to a mobile app that allows them to track their mood, stress, and medication adherence, access an anonymous online community, securely message providers, and receive medication refill alerts. Provider participants will be able to view the information entered by enrolled clients, securely message clients, and track medication refill processes. Study participants will be asked to provide feedback on usability, utility, impact, and effectiveness of the program. Additional assessments will evaluate for impact on medication refill adherence and patient-provider communication.

Studietype

Intervensjonell

Registrering (Forventet)

26

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Virginia
      • Richmond, Virginia, Forente stater, 23228
        • Henrico Health Department

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Patient Inclusion Criteria:

  • Currently picking up of receiving medications through ADAP from the Henrico Health Department; Able to read in English; Able to speak English; Able to sign informed consent

Provider Inclusion Criteria:

  • Current Henrico Health Department employee working with the ADAP pharmacy; Able to read in English; Able to speak English; Able to sign informed consent

Exclusion Criteria:

  • Severe cognitive impairment that interferes with a subjects ability to consent; non-English speaking; Prisoners

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Provider Participants
Employees who work with medication refills through the AIDS Drug Assistance Program at the Henrico Health Department will be invited to participate in the study as providers. Provider participants will receive access to a web based system that allows them to view information for their enrolled clients, securely message clients, and track medication refills. Providers will be asked to participate in a 30-day usability interview and a end-of-study assessment.
Annen: PositiveLinks RX Portal
An online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking.
Annen: Patient Participants
Clients who receive medication refills through the AIDS Drug Assistance Program at the Henrico Health Department will be invited to participate in the study as patients. Patient participants will be provided access to a mobile app that allows them to track their mood, stress, and medication adherence, access an anonymous online community, securely message providers, and receive medication refill alerts
Annen: PositiveLinks RX Mobile App
A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Patient Medication Refill Compliance
Tidsramme: Assessed at baseline and 6-months
Primary variable analysis will include examination of patient medication refill compliance at baseline and at the 6-month follow-up to assess for any change in refill compliance.
Assessed at baseline and 6-months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
App Usability
Tidsramme: 30-days after enrollment
Assessed through the system usability scale (SUS), a validated ten item scale. Additional usability factors will be assessed through qualitative methods.
30-days after enrollment
Participant Check-In Engagement
Tidsramme: Assessed at 6-months
Examining participant app engagement through assessment of check-in response rates
Assessed at 6-months
Participant Messaging Engagement
Tidsramme: Assessed at 6-months
Examining participant app engagement through assessment of messages sent and received
Assessed at 6-months
Participant Community Engagement
Tidsramme: Assessed at 6-months
Examining participant app engagement through assessment of community posts
Assessed at 6-months
Participant Feature Engagement
Tidsramme: Assessed at 6-months
Examining participant app engagement through assessment of page views
Assessed at 6-months
Change in Patient Refill Satisfaction
Tidsramme: Assessed at baseline and 6-months
Assessment of change in patient satisfaction with the refill process at their local health department. Utilizes a patient satisfaction with pharmaceutical services scale.
Assessed at baseline and 6-months
Change in Provider Communication
Tidsramme: Assessed at baseline and 6-months
Assessment of change in patient perception of provider (local health department staff) communication. Utilizes the Consultation and Relational Empathy (CARE) scale.
Assessed at baseline and 6-months
Program Alignment with Health Department Workflow
Tidsramme: Assessed at 30-days and 6-months
Assessing alignment with health department workflow through provider end-of-study and usability interviews
Assessed at 30-days and 6-months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Virginia

Samarbeidspartnere

Virginia Department of Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. mars 2019

Primær fullføring (Forventet)

1. september 2019

Studiet fullført (Forventet)

1. september 2019

Datoer for studieregistrering

Først innsendt

25. februar 2019

Først innsendt som oppfylte QC-kriteriene

13. mars 2019

Først lagt ut (Faktiske)

15. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 21185

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på Hiv

Kliniske studier på PositiveLinks RX Portal

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Sponsorer og samarbeidspartnere

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