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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02895802
Other study ID # 6360
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date October 25, 2017

Study information

Verified date January 2019
Source Advocate Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 25, 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Verbal instructions with picture diagram
verbal instructions and picture diagram
Verbal instructions with video of ADSC
Verbal instructions and watching video depicting ADSC
verbal instructions w. video of w/o DS
verbal instructions and watching video depicting person without DS washing her hands
verbal instructions w. video w/DS
verbal instructions and watching video depicting person with DS washing his hands

Locations

Country Name City State
United States Adult Down Syndrome Center / Russell Institute for Research and Innovation Park Ridge Illinois

Sponsors (1)

Lead Sponsor Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

References & Publications (5)

Global consensus conference: final recommendations. Am J Infect Control. 1999 Dec;27(6):503-13. Review. — View 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(®) and iPads(®) in teaching programs for individuals with developmental disabilities: a systematic — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 minutes
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