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Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications

19. april 2022 oppdatert av: Wake Forest University Health Sciences

The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.

Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.

Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.

Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.

Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Study Design:

The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.

Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.

Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.

Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.

Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.

Methods:

  1. A responsible clinician who has acquainted himself/herself with the research protocol will explain the study to each patient. Patients who agree to participate will sign a form documenting informed consent. The patient will then be handed an envelope that determines whether they will receive web-based teaching or one-on-one teaching.
  2. The patients receiving web-based teaching will be taken to a private room to watch a video on injectable medication use. The amount of time required to view the video will be recorded. The video can be paused, rewound and watched as many times as the patient desires.
  3. The patients randomized to one-on-one teaching will be taken to a separate room where they will be taught injectable medication use by one of two training healthcare providers with experience teaching injectable medications. The time spent in the teaching session will be recorded.
  4. After the teaching session, each patient in the study will complete a multiple choice post-test regarding their knowledge of injectable medication use. They will also complete a satisfaction survey which will use a Likert scale to assess the patients' responses. The instructors teaching the one-on-one sessions will not have access to the post-test.

Statistics:

The categorical variables will be summarized with frequencies and percentages while the continuous variables will be evaluated with means and standard deviations. A difference in proportion will be tested based on the data collected between the web-based group and didactic group. Non-inferiority testing will be conducted based on these differences with a 5% significance level. Data analysis will be conducted using SAS statistical software (9.2,Cary,NC,USA) .

Sample Size Estimate:

To predict that the web-based testing group is not inferior to the Didactic testing group about 40 people in each group would be needed to achieve 80% power with a 5% significance level. The sample size needed was calculated using the Z-test. Here it is assumed that the didactic group would get 80% of their answers correct and the web-based group would actually have 90% of their answers correct.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28204
        • Carolinas Medical Center - Women's Institute

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 til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Patient undergoing ART Therapy and ovulation induction via gonadotropins injection.

Exclusion Criteria:

  • Any patient with prior history of IVF injectable use will be excluded from the study.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Nurse instruction
Traditional injection teaching method. No video instruction
Nurse directed instruction
Annen: Video instruction
Video instruction that can be paused/repeated by subject
Patient Directed Video Instruction

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tthe level of knowledge after the intervention measured by a multiple choice post-test
Tidsramme: approximately 1 hour
multiple choice post-test regarding their knowledge of injectable medication use
approximately 1 hour

Sekundære resultatmål

Resultatmål
Tidsramme
Satisfaction with education measured by the Likert scale survey
Tidsramme: post intervention
post intervention

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Michelle Matthews, MD, Wake Forest University Health Sciences

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 2012

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. april 2015

Datoer for studieregistrering

Først innsendt

13. april 2015

Først innsendt som oppfylte QC-kriteriene

17. april 2015

Først lagt ut (Anslag)

20. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2022

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 06-12-10E

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. .

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