- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895802
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)
Purpose: To assess the feasibility of using videos depicting people with DS to teach other adults with DS to perform healthy behaviors.
Hypothesis: Videos of adults with DS performing healthy behaviors is a more effective way to promote healthy behaviors by adults with DS than other methods tested.
This project will study whether videos showing a person with DS washing his hands correctly can improve hand washing by other adults with DS.
Study Overview
Status
Conditions
Detailed Description
The subjects will be recruited and identified and consented. Subjects will be randomized to one of 4 groups.
i. Verbal instructions on hand washing with pictures (using the Illinois department of public health tools) ii. Verbal instructions on hand washing and video of the ADSC iii. Verbal instructions on hand washing and video of an adult without DS washing his hands iv. Verbal instructions on hand washing and video of an adult with DS washing his hands.
Videos of the handwashing process will be taken pre intervention and then again post intervention.
Scoring assessments will be completed upon review of the 2 files by 2 separate study team members, the second of which will be blinded to the information they will be reviewing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Park Ridge, Illinois, United States, 60068
- Adult Down Syndrome Center / Russell Institute for Research and Innovation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People with Down syndrome receiving care at Advocate
- No known sensitivity to soap
Exclusion Criteria:
- Pregnant women, prisoners
- Known sensitivity to soap
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Verbal instructions with picture diagram
hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a picture diagram of handwashing.
|
verbal instructions and picture diagram
|
Other: Verbal instructions with video of ADSC
hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a video of the adult down syndrome center
|
Verbal instructions and watching video depicting ADSC
|
Other: verbal instructions w. video of w/o DS
hand washing is scored prior and after educational intervention with verbal instructions of handwashing and viewing an educational video depicting a person without down syndrome washing their hands.
|
verbal instructions and watching video depicting person without DS washing her hands
|
Other: verbal instructions w.video w/DS
hand washing is scored prior and after educational intervention with verbal instructions of handwashing and watching an educational video depicting a person with down syndrome washing their hands.
|
verbal instructions and watching video depicting person with DS washing his hands
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on handwashing checklist
Time Frame: 2 minutes
|
2 minute videos will be reviewed and scored twice.
First by research coordinator then by blinded reviewer.
Scores will be compared and reported.
|
2 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian Chicoine, MD, Advocate Health and Hospitals Corporation
Publications and helpful links
General Publications
- Ram G, Chinen J. Infections and immunodeficiency in Down syndrome. Clin Exp Immunol. 2011 Apr;164(1):9-16. doi: 10.1111/j.1365-2249.2011.04335.x. Epub 2011 Feb 24.
- Parker RM, Ratzan SC, Lurie N. Health literacy: a policy challenge for advancing high-quality health care. Health Aff (Millwood). 2003 Jul-Aug;22(4):147-53. doi: 10.1377/hlthaff.22.4.147.
- Lee RL, Lee PH. To evaluate the effects of a simplified hand washing improvement program in schoolchildren with mild intellectual disability: a pilot study. Res Dev Disabil. 2014 Nov;35(11):3014-25. doi: 10.1016/j.ridd.2014.07.016. Epub 2014 Aug 12.
- Kagohara DM, van der Meer L, Ramdoss S, O'Reilly MF, Lancioni GE, Davis TN, Rispoli M, Lang R, Marschik PB, Sutherland D, Green VA, Sigafoos J. Using iPods((R)) and iPads((R)) in teaching programs for individuals with developmental disabilities: a systematic review. Res Dev Disabil. 2013 Jan;34(1):147-56. doi: 10.1016/j.ridd.2012.07.027. Epub 2012 Aug 30.
- Global consensus conference: final recommendations. Am J Infect Control. 1999 Dec;27(6):503-13. doi: 10.1016/s0196-6553(99)70029-5. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6360
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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