Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

An Automated, Tailored Information Application for Medication Health Literacy

28. februar 2013 oppdatert av: Nova Southeastern University
The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Health literacy is a critically important problem in improving the effectiveness of health care interventions. Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects. An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model. The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model. The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application. Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills. Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics. This computer-based program will provide training, test understanding, and if necessary reteach and retest. It will also provide printed information for participants to take home to provide ongoing prompts. This study will comprise two phases. In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials. In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.

Studietype

Intervensjonell

Registrering (Faktiske)

124

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33328
        • Ziff Health Clinics, Nova Southeastern University

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

Inclusion Criteria:

  • Aged 18 years or older
  • Currently treated with at least one medication for HIV infection
  • No change in target medication anticipated in the next two months
  • Able to participate in the study intervention in English

Exclusion Criteria:

  • Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
  • Not able to participate in the intervention using English.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tailored Information
Participants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection.
The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.
Andre navn:
  • Health literacy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Medication adherence
Tidsramme: Four weeks after intervention
Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.
Four weeks after intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant self-efficacy
Tidsramme: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Mood
Tidsramme: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Elements of the Information, Motivation, and Behavioral Skills Model
Tidsramme: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.
Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Intervention acceptability and usability
Tidsramme: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention
A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.
Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention

Samarbeidspartnere og etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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

1. juni 2010

Primær fullføring (Faktiske)

1. november 2011

Studiet fullført (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først innsendt

18. februar 2011

Først innsendt som oppfylte QC-kriteriene

23. februar 2011

Først lagt ut (Anslag)

25. februar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. mars 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. februar 2013

Sist bekreftet

1. februar 2013

Mer informasjon

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 Humant immunsviktvirus I Infeksjon

Kliniske studier på Tailored Information

3
Abonnere