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Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verbal instructions with picture diagram
Verbal instructions with video of ADSC
verbal instructions w. video of w/o DS
verbal instructions w. video w/DS
Sponsored by
Advocate Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Down Syndrome focused on measuring down syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • People with Down syndrome receiving care at Advocate
  • No known sensitivity to soap

Exclusion Criteria:

  • Pregnant women, prisoners
  • Known sensitivity to soap

Sites / Locations

  • Adult Down Syndrome Center / Russell Institute for Research and Innovation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Verbal instructions with picture diagram

Verbal instructions with video of ADSC

verbal instructions w. video of w/o DS

verbal instructions w.video w/DS

Arm Description

hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a picture diagram of handwashing.

hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a video of the adult down syndrome center

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.

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.

Outcomes

Primary Outcome Measures

Score on handwashing checklist
2 minute videos will be reviewed and scored twice. First by research coordinator then by blinded reviewer. Scores will be compared and reported.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2016
Last Updated
January 21, 2019
Sponsor
Advocate Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT02895802
Brief Title
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)
Official Title
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
down syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal instructions with picture diagram
Arm Type
Other
Arm Description
hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a picture diagram of handwashing.
Arm Title
Verbal instructions with video of ADSC
Arm Type
Other
Arm Description
hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a video of the adult down syndrome center
Arm Title
verbal instructions w. video of w/o DS
Arm Type
Other
Arm Description
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.
Arm Title
verbal instructions w.video w/DS
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Verbal instructions with picture diagram
Intervention Description
verbal instructions and picture diagram
Intervention Type
Behavioral
Intervention Name(s)
Verbal instructions with video of ADSC
Intervention Description
Verbal instructions and watching video depicting ADSC
Intervention Type
Behavioral
Intervention Name(s)
verbal instructions w. video of w/o DS
Intervention Description
verbal instructions and watching video depicting person without DS washing her hands
Intervention Type
Behavioral
Intervention Name(s)
verbal instructions w. video w/DS
Intervention Description
verbal instructions and watching video depicting person with DS washing his hands
Primary Outcome Measure Information:
Title
Score on handwashing checklist
Description
2 minute videos will be reviewed and scored twice. First by research coordinator then by blinded reviewer. Scores will be compared and reported.
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: People with Down syndrome receiving care at Advocate No known sensitivity to soap Exclusion Criteria: Pregnant women, prisoners Known sensitivity to soap
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Chicoine, MD
Organizational Affiliation
Advocate Health and Hospitals Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adult Down Syndrome Center / Russell Institute for Research and Innovation
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21352207
Citation
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.
Results Reference
result
PubMed Identifier
12889762
Citation
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.
Results Reference
result
PubMed Identifier
25124699
Citation
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.
Results Reference
result
PubMed Identifier
22940168
Citation
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.
Results Reference
result
PubMed Identifier
10586155
Citation
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.
Results Reference
result

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Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)

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