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Informed Consent Formats by Information Preference and Priority

24 januari 2018 bijgewerkt door: Carnegie Mellon University
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • Carnegie Mellon University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 18 Years Old or Older
  • Read and agreed to informed consent
  • Indicated desire to participate
  • Diagnosed with asthma
  • US resident

Exclusion Criteria:

  • Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Original
Participants will review the full-length, original consent form for the clinical trial.
Gedragsmatig: Original consent form
Participants will review the full-length, original consent form for the clinical trial.
Experimenteel: Shortened
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
Gedragsmatig: Shortened consent form
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
Experimenteel: Reordered
Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
Gedragsmatig: Reordered, shortened consent form
Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
Experimenteel: Highlighted
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
Gedragsmatig: Shortened consent form with a highlights box
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
Experimenteel: Interactive
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.
Gedragsmatig: Interactive, shortened consent form
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Score for high impact questions
Tijdsspanne: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study.
through study completion, an average of 30 minutes

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Score for low impact questions
Tijdsspanne: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for any item relating to material that was rated as 49 or lower on impact on willingness to enroll in a previous study.
through study completion, an average of 30 minutes
Total score for all questions
Tijdsspanne: through study completion, an average of 30 minutes
Sum of correct answers (T/F) on full knowledge test.
through study completion, an average of 30 minutes
Interaction effect of format and importance on likelihood of correct answer
Tijdsspanne: through study completion, an average of 30 minutes
Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.
through study completion, an average of 30 minutes
Scores for different information categories
Tijdsspanne: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for each of the 20 information categories
through study completion, an average of 30 minutes
Effect of location on score
Tijdsspanne: through study completion, an average of 30 minutes
Logistic regression coefficient of likelihood of predicting a correct answer, based upon the location on which the sentence appeared--uses only the shortened, and the reordered conditions. Note that sentences appearing in the introduction (which is the first section of all treatments) must be dropped, as there will be no variation in location.
through study completion, an average of 30 minutes
Decision to enroll
Tijdsspanne: through study completion, an average of 30 minutes
Likert measure of participants hypothetical decision to enroll in the study
through study completion, an average of 30 minutes
Confidence in enrollment decision
Tijdsspanne: through study completion, an average of 30 minutes
Likert measure of participants confidence in hypothetical decision to enroll in the study
through study completion, an average of 30 minutes
Satisfaction with consent structure
Tijdsspanne: through study completion, an average of 30 minutes
Likert measure of participants satisfaction with the consent form
through study completion, an average of 30 minutes
Perception of investigator concern for well being
Tijdsspanne: through study completion, an average of 30 minutes
Likert measure of participants belief in the investigator's concerns for the participant's well-being
through study completion, an average of 30 minutes
Perception of investigator transparency
Tijdsspanne: through study completion, an average of 30 minutes
Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately
through study completion, an average of 30 minutes
Participant's probability estimate of the likelihood that the treatment would help control their asthma
Tijdsspanne: through study completion, an average of 30 minutes

Survey question of the following form:

'If you enrolled in the trial described in the consent form, what is the probability that the treatment could help control your asthma better, where 0% means "no chance at all of helping" and 100% means "would definitely help"?'

Participants provided with drop-down menu including values from 0% to 100% in increments of 1%.
through study completion, an average of 30 minutes

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Participant's free-response text describing what was learned from reading the informed consent document
Tijdsspanne: through study completion, an average of 30 minutes

Survey question of the following form:

"What are some of the key things you learned from reading the informed consent document?"

Participants are then provided with an free-response text box where they are allowed to enter whatever text they want, as long as they enter some text. These responses will be coded by two independent coders, blinded to the treatment arms, using an emergent coding system to identify different topics that participants may raise.
through study completion, an average of 30 minutes

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Carnegie Mellon University

Medewerkers

ICON plc

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 november 2017

Primaire voltooiing (Werkelijk)

31 december 2017

Studie voltooiing (Werkelijk)

31 december 2017

Studieregistratiedata

Eerst ingediend

8 januari 2018

Eerst ingediend dat voldeed aan de QC-criteria

24 januari 2018

Eerst geplaatst (Werkelijk)

31 januari 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 januari 2018

Laatste update ingediend die voldeed aan QC-criteria

24 januari 2018

Laatst geverifieerd

1 januari 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • STUDY2017_00000268

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate. As such, a clear delineation of what data will be disclosed is not yet available.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Original consent form

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