<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01704560</url>
  </required_header>
  <id_info>
    <org_study_id>39377</org_study_id>
    <nct_id>NCT01704560</nct_id>
  </id_info>
  <brief_title>Improving Measurement Of Parents' Understanding Of Research Permission</brief_title>
  <official_title>IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Well-informed potential subjects are presumably better able to make autonomous decisions&#xD;
      about the risks and benefits of participating in a research study than those in possession of&#xD;
      less information. In actuality, prior research into consent understanding suggests that&#xD;
      longer forms offering exhaustive information may inhibit rather than promote understanding.&#xD;
      Moreover, technical wording in tools used to measure parent understanding of research&#xD;
      permission may also lead to inhibition of understanding. This study will test the hypothesis&#xD;
      that, among parents of potential subjects for greater-than-minimal-risk research, two&#xD;
      modified and simplified subset of questions from the Deaconess Informed Consent Comprehension&#xD;
      Test (DICCT), one oral and open-ended and one written and multiple choice, will increase&#xD;
      subject understanding of the nature and risks of the research. The study will enroll the&#xD;
      parents of 40 potential neonatal research subjects with an interim analysis of data at 20&#xD;
      subjects. Subjects will review a sham research permission form and will be randomized 1:1 to&#xD;
      complete one of the two modified comprehension tests in addition to the DICCT (gold-standard)&#xD;
      test. Parents will be given an open-ended survey after the tests in order to qualitatively&#xD;
      describe their opinions of each test. A subset of parents who have received the written form&#xD;
      will also undergo a cognitive interview about the form. A similar subset will also be given&#xD;
      an open-ended survey about a proposed permission form cover sheet. The primary outcome will&#xD;
      be the correlation of scores between the DICCT and modified comprehension tests, following&#xD;
      the sham informed consent process.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2012</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DICCT Questionnaire</measure>
    <time_frame>Within 2 weeks after being approached for participation.</time_frame>
    <description>Score on the post-permission DICCT questionnaire. The DICCT is scored on a 28 point scale, with each of 14 parameters being scored as 0 = incorrect, 1 = partially correct, 2 = correct. The DICCT, in addition to being previously validated, has other advantages. It contains questions that are not directly addressed in the cover sheet, but addressed in the full permission form, such as compensation for injury. These items will serve as valuable internal controls. The DICCT is easily adaptable to written answers, which makes it ideal for further modification in future studies.&#xD;
The DICCT will be administered during a structured interview, without a time limit. The parent will be allowed to refer to the permission form to answer the questions.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Improve Parent Understanding of Research Permission</condition>
  <arm_group>
    <arm_group_label>Coversheet to Informed Consent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coversheet attached to Informed Consent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Coversheet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard, full permission form, without the coversheet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coversheet to Informed Consent</intervention_name>
    <description>The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.</description>
    <arm_group_label>Coversheet to Informed Consent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of potential subjects eligible for a NICHD Neonatal Research Network (NRN)&#xD;
             interventional trial (&quot;Hydrocortisone/Extubation&quot;) or greater-than-minimal risk&#xD;
             observational trial (&quot;PROP&quot;)&#xD;
&#xD;
          -  Permission being sought for a qualifying study&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Permission has not been previously sought for another qualifying study&#xD;
&#xD;
          -  Illiteracy (unable to read simple forms)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl T D'Angio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women and Children's Hospital of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann Marie Scorsone</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Carl D'Angio</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704560
org study id: 39377
nct id: NCT01704560
lead sponsor: 
has dmc: Yes
Well-informed potential subjects are presumably better able to make autonomous decisions
      about the risks and benefits of participating in a research study than those in possession of
      less information. In actuality, prior research into consent understanding suggests that
      longer forms offering exhaustive information may inhibit rather than promote understanding.
      Moreover, technical wording in tools used to measure parent understanding of research
      permission may also lead to inhibition of understanding. This study will test the hypothesis
      that, among parents of potential subjects for greater-than-minimal-risk research, two
      modified and simplified subset of questions from the Deaconess Informed Consent Comprehension
      Test (DICCT), one oral and open-ended and one written and multiple choice, will increase
      subject understanding of the nature and risks of the research. The study will enroll the
      parents of 40 potential neonatal research subjects with an interim analysis of data at 20
      subjects. Subjects will review a sham research permission form and will be randomized 1:1 to
      complete one of the two modified comprehension tests in addition to the DICCT (gold-standard)
      test. Parents will be given an open-ended survey after the tests in order to qualitatively
      describe their opinions of each test. A subset of parents who have received the written form
      will also undergo a cognitive interview about the form. A similar subset will also be given
      an open-ended survey about a proposed permission form cover sheet. The primary outcome will
      be the correlation of scores between the DICCT and modified comprehension tests, following
      the sham informed consent process.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: DICCT Questionnaire
time frame: Within 2 weeks after being approached for participation.
description: Score on the post-permission DICCT questionnaire. The DICCT is scored on a 28 point scale, with each of 14 parameters being scored as 0 = incorrect, 1 = partially correct, 2 = correct. The DICCT, in addition to being previously validated, has other advantages. It contains questions that are not directly addressed in the cover sheet, but addressed in the full permission form, such as compensation for injury. These items will serve as valuable internal controls. The DICCT is easily adaptable to written answers, which makes it ideal for further modification in future studies.
The DICCT will be administered during a structured interview, without a time limit. The parent will be allowed to refer to the permission form to answer the questions.
arm group label: Coversheet to Informed Consent
arm group type: Experimental
description: Coversheet attached to Informed Consent.
arm group label: No Coversheet
arm group type: No Intervention
description: Standard, full permission form, without the coversheet.
intervention type: Other
intervention name: Coversheet to Informed Consent
description: The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.
arm group label: Coversheet to Informed Consent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Carl T D'Angio, MD
role: Principal Investigator
affiliation: University of Rochester
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Carl D'Angio
investigator title: Professor