NCT02895802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

October 4, 2024

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

August 27, 2016

Last Update Submit

October 2, 2024

Conditions

Keywords

down syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Verbal instructions with picture diagram

OTHER

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

Behavioral: Verbal instructions with picture diagram

Verbal instructions with video of ADSC

OTHER

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

Behavioral: Verbal instructions with video of ADSC

verbal instructions w. video of w/o DS

OTHER

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.

Behavioral: verbal instructions w. video of w/o DS

verbal instructions w.video w/DS

OTHER

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.

Behavioral: verbal instructions w. video w/DS

Interventions

verbal instructions and picture diagram

Verbal instructions with picture diagram

Verbal instructions and watching video depicting ADSC

Verbal instructions with video of ADSC

verbal instructions and watching video depicting person without DS washing her hands

verbal instructions w. video of w/o DS

verbal instructions and watching video depicting person with DS washing his hands

verbal instructions w.video w/DS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant women, prisoners
  • Known sensitivity to soap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult Down Syndrome Center / Russell Institute for Research and Innovation

Park Ridge, Illinois, 60068, United States

Location

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Brian Chicoine, MD

    Advocate Health and Hospitals Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 12, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

October 25, 2017

Last Updated

October 4, 2024

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations