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Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03551418
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Chicoine, Advocate Health Care

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE June 11, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE June 9, 2018
Estimated Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
Appropriate hand washing technique [ Time Frame: 2 months ]
Measuring appropriate replicating of standard hand washing techniques via standard check list
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03551418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome
Official Title  ICMJE Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome
Brief Summary The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied.
Detailed Description This study is a next step in evaluating the use of videos depicting a person with DS demonstrating hand washing. The initial study demonstrated improvement in hand washing technique with a verbal explanation of hand washing technique using an Illinois Department of Public Health handout and viewing one of the handwashing videos one time. The study demonstrated a statistical significant difference between learning by viewing the handout and a video of an adult with DS washing his hands vs just viewing the handout.viewing a handout Likely due to small sample size, the study did not demonstrate statistical significance between watching the video of a person with DS washing his hands vs watching the other videos but the trend for the best improvement in handwashing technique was for the group viewing another person with DS demonstrating the handwashing. The hypothesis of this study is that repeated viewing of a video and practicing hand washing will lead to even greater improvement in hand washing technique.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Down Syndrome
  • Trisomy 21
Intervention  ICMJE Behavioral: Watching a video
Watching a video of an adult with DS washing his hands
Study Arms  ICMJE Experimental: Repetitive video watching
Repetitively watching a video of an adult with Down Syndrome washing his hands
Intervention: Behavioral: Watching a video
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 9, 2020
Estimated Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

Individuals with:

  • DS aged 18 and older
  • The ability to use a checklist or to be taught how to use a checklist
  • The ability to use a tablet or to be taught how to use a tablet
  • Access to an Internet connection

Exclusion criteria

Individuals who:

  • Are not yet adults
  • Are unwilling to consent and/or assent
  • Are unable or unwilling to return the ADSC for the 1 month and 2 months follow up visits
  • sensitivity to soap
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gina Littlejohn, BSN RN 847.723.2099 gina.littlejohn@advocatehealth.com
Contact: Brian Chicoine, MD 847.318.2303 Brian.Chicoine@advocatehealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03551418
Other Study ID Numbers  ICMJE AHC IRB 6884
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Chicoine, Advocate Health Care
Study Sponsor  ICMJE Advocate Health Care
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Chicoine, MD Advocate Health Care
PRS Account Advocate Health Care
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP