- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03416907
Informed Consent Formats by Information Preference and Priority
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Carnegie Mellon University
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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:
- 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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Original
Participants will review the full-length, original consent form for the clinical trial.
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Participants will review the full-length, original consent form for the clinical trial.
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Eksperimentell: 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.
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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.
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Eksperimentell: 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).
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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).
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Eksperimentell: 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.
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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.
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Score for high impact questions
Tidsramme: through study completion, an average of 30 minutes
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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.
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through study completion, an average of 30 minutes
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Score for low impact questions
Tidsramme: 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
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Total score for all questions
Tidsramme: through study completion, an average of 30 minutes
|
Sum of correct answers (T/F) on full knowledge test.
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through study completion, an average of 30 minutes
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Interaction effect of format and importance on likelihood of correct answer
Tidsramme: through study completion, an average of 30 minutes
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Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.
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through study completion, an average of 30 minutes
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Scores for different information categories
Tidsramme: through study completion, an average of 30 minutes
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Sum of correct answers (T/F) for each of the 20 information categories
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through study completion, an average of 30 minutes
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Effect of location on score
Tidsramme: through study completion, an average of 30 minutes
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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.
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through study completion, an average of 30 minutes
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Decision to enroll
Tidsramme: through study completion, an average of 30 minutes
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Likert measure of participants hypothetical decision to enroll in the study
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through study completion, an average of 30 minutes
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Confidence in enrollment decision
Tidsramme: through study completion, an average of 30 minutes
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Likert measure of participants confidence in hypothetical decision to enroll in the study
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through study completion, an average of 30 minutes
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Satisfaction with consent structure
Tidsramme: through study completion, an average of 30 minutes
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Likert measure of participants satisfaction with the consent form
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through study completion, an average of 30 minutes
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Perception of investigator concern for well being
Tidsramme: through study completion, an average of 30 minutes
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Likert measure of participants belief in the investigator's concerns for the participant's well-being
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through study completion, an average of 30 minutes
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Perception of investigator transparency
Tidsramme: through study completion, an average of 30 minutes
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Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately
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through study completion, an average of 30 minutes
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Participant's probability estimate of the likelihood that the treatment would help control their asthma
Tidsramme: through study completion, an average of 30 minutes
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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
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Participant's free-response text describing what was learned from reading the informed consent document
Tidsramme: through study completion, an average of 30 minutes
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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
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Nøkkelord
Andre studie-ID-numre
- STUDY2017_00000268
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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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