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Trial record 2 of 2 for:    BMT CTN 0901

Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)

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ClinicalTrials.gov Identifier: NCT02081248
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Improve the Informed Consent Process
Interventions: Other: Consent Form Specific Format 1
Other: Consent Form Specific Format 2

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Consent

This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.

Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.

Easy-to-Read Informed Consent

This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.

Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.


Participant Flow:   Overall Study
    Standard Consent   Easy-to-Read Informed Consent
STARTED   98   100 
COMPLETED   76   87 
NOT COMPLETED   22   13 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled participants

Reporting Groups
  Description
Standard Consent

This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.

Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.

Easy-to-Read Informed Consent

This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.

Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.

Total Total of all reporting groups

Baseline Measures
   Standard Consent   Easy-to-Read Informed Consent   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   100   198 
Age 
[Units: Years]
Median (Full Range)
 61 
 (27 to 73) 
 61 
 (21 to 76) 
 61 
 (21 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      45  45.9%      43  43.0%      88  44.4% 
Male      53  54.1%      57  57.0%      110  55.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   5.1%      2   2.0%      7   3.5% 
Not Hispanic or Latino      87  88.8%      94  94.0%      181  91.4% 
Unknown or Not Reported      6   6.1%      4   4.0%      10   5.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White      85  86.7%      88  88.0%      173  87.4% 
Black      7   7.1%      8   8.0%      15   7.6% 
Other      2   2.0%      2   2.0%      4   2.0% 
Unknown or Not Reported      4   4.1%      2   2.0%      6   3.0% 
Annual Household Income 
[Units: Participants]
Count of Participants
     
Less than $40,000      11  11.2%      19  19.0%      30  15.2% 
$40,000-79,999      25  25.5%      20  20.0%      45  22.7% 
$80,000 or More      22  22.4%      26  26.0%      48  24.2% 
Unknown or Not Reported      40  40.8%      35  35.0%      75  37.9% 
Education Level 
[Units: Participants]
Count of Participants
     
High School or Less      20  20.4%      35  35.0%      55  27.8% 
Post-high School, but Less than Graduate Degree      29  29.6%      27  27.0%      56  28.3% 
Graduate Degree or More      15  15.3%      11  11.0%      26  13.1% 
Other      5   5.1%      6   6.0%      11   5.6% 
Unknown or Not Reported      29  29.6%      21  21.0%      50  25.3% 
Parent Clinical Trial [1] 
[Units: Participants]
Count of Participants
     
BMT CTN 0901      10  10.2%      11  11.0%      21  10.6% 
BMT CTN 1101      25  25.5%      22  22.0%      47  23.7% 
BMT CTN 1203      50  51.0%      51  51.0%      101  51.0% 
BMT CTN 1301      13  13.3%      16  16.0%      29  14.6% 
[1] Participants for the ETRIC (BMT CTN 1205) study were recruited from those that were potentially eligible for BMT CTN 0901, 1101, 1203, or 1301 (NCT01339910, NCT01597778, NCT02208037, and NCT02345850, respectively). The parent clinical trial is the BMT CTN trial for which the participant was potentially eligible.


  Outcome Measures

1.  Primary:   Quality of Informed Consent Part A (QuIC-A) Score   [ Time Frame: Within 7 days of consent discussion ]

2.  Secondary:   Quality of Informed Consent Part B (QuIC-B) Score   [ Time Frame: Within 7 days of consent discussion ]

3.  Secondary:   Modified Deaconess Informed Consent Comprehension Test (DICCT)   [ Time Frame: WIthin 7 days of consent discussion ]

4.  Secondary:   REALM-R Score   [ Time Frame: Within 7 days of consent discussion ]

5.  Secondary:   Newest Vital Sign (NVS) Score   [ Time Frame: Within 7 days of consent discussion ]

6.  Secondary:   State Trait Anxiety Inventory (STAI) Score   [ Time Frame: Within 7 days of consent discussion ]

7.  Secondary:   Participant Satisfaction With Consent Process   [ Time Frame: Within 7 days of consent discussion ]

8.  Secondary:   Participant Information Location Time   [ Time Frame: Within 7 days of consent discussion ]

9.  Secondary:   Consent Rate on Parent Trial   [ Time Frame: Within 7 days of consent discussion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Adam Mendizabal, PhD
Organization: The Emmes Corporation
phone: 301-251-1161
e-mail: amendizabal@emmes.com



Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02081248     History of Changes
Other Study ID Numbers: BMTCTN1205
2U10HL069294-11 ( U.S. NIH Grant/Contract )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2013
First Posted: March 7, 2014
Results First Submitted: March 28, 2018
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018