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Informed Consent Formats by Information Preference and Priority

NCT ID: NCT03416907

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Consent Forms Asthma

Keywords

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Informed consent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Original

Participants will review the full-length, original consent form for the clinical trial.

Group Type ACTIVE_COMPARATOR

Original consent form

Intervention Type BEHAVIORAL

Participants will review the full-length, original consent form for the clinical trial.

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.

Group Type EXPERIMENTAL

Shortened consent form

Intervention Type BEHAVIORAL

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.

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).

Group Type EXPERIMENTAL

Reordered, shortened consent form

Intervention Type BEHAVIORAL

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).

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.

Group Type EXPERIMENTAL

Shortened consent form with a highlights box

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Interactive, shortened consent form

Intervention Type BEHAVIORAL

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.

Interventions

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Original consent form

Participants will review the full-length, original consent form for the clinical trial.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICON plc

INDUSTRY

Sponsor Role collaborator

Carnegie Mellon University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carnegie Mellon University

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY2017_00000268

Identifier Type: -

Identifier Source: org_study_id