- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03416907
Informed Consent Formats by Information Preference and Priority
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Carnegie Mellon University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Score for low 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 49 or lower 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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Total score for all questions
Tidsramme: through study completion, an average of 30 minutes
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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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- STUDY2017_00000268
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Original consent form
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University of PennsylvaniaAfsluttet
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Yale UniversityAfsluttetPatientcentreret resultatforskningForenede Stater
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Dr. Reddy's Laboratories LimitedUkendt
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Hannover Medical SchoolFresenius KabiAfsluttetSepsis | Systemisk inflammatorisk responssyndrom | Kritisk sygdom | VoksenTyskland
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German Cancer Research CenterUniversity of Music, Drama, and Media HannoverIkke rekrutterer endnu
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SanofiRekrutteringSunde frivillige | Autoimmun lidelseForenede Stater
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Oslo University HospitalUniversity of Oslo; Norwegian National Advisory Unit on Rare Disorders... og andre samarbejdspartnereTilmelding efter invitationArvelig motorisk og sensorisk neuropati | Polyneuropatier | Charcot-Marie-ToothNorge
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First Affiliated Hospital Xi'an Jiaotong UniversityRekrutteringVirussygdomme | Hepatitis B, kroniskKina
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Tampere University HospitalTurku University Hospital; Kuopio University Hospital; Seinajoki Central... og andre samarbejdspartnereTilmelding efter invitationCøliaki | Kost, glutenfri | Cøliaki hos børn | Opfølgning | Overgang af omsorgFinland
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CHU de ReimsAfsluttet