Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02895802
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2016-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2016-08-27', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on handwashing checklist', 'timeFrame': '2 minutes', 'description': '2 minute videos will be reviewed and scored twice. First by research coordinator then by blinded reviewer. Scores will be compared and reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['down syndrome'], 'conditions': ['Down Syndrome']}, 'referencesModule': {'references': [{'pmid': '21352207', 'type': 'RESULT', '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.'}, {'pmid': '12889762', 'type': 'RESULT', '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.'}, {'pmid': '25124699', 'type': 'RESULT', '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.'}, {'pmid': '22940168', 'type': 'RESULT', '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."}, {'pmid': '10586155', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To assess the feasibility of using videos depicting people with DS to teach other adults with DS to perform healthy behaviors.\n\nHypothesis: 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.\n\nThis project will study whether videos showing a person with DS washing his hands correctly can improve hand washing by other adults with DS.', 'detailedDescription': 'The subjects will be recruited and identified and consented. Subjects will be randomized to one of 4 groups.\n\ni. 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.\n\nVideos of the handwashing process will be taken pre intervention and then again post intervention.\n\nScoring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with Down syndrome receiving care at Advocate\n* No known sensitivity to soap\n\nExclusion Criteria:\n\n* Pregnant women, prisoners\n* Known sensitivity to soap'}, 'identificationModule': {'nctId': 'NCT02895802', 'briefTitle': 'Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)', 'orgStudyIdInfo': {'id': '6360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Verbal instructions with picture diagram', 'description': 'hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a picture diagram of handwashing.', 'interventionNames': ['Behavioral: Verbal instructions with picture diagram']}, {'type': 'OTHER', 'label': 'Verbal instructions with video of ADSC', 'description': 'hand washing is scored prior and after educational intervention with verbal instructions of handwashing and a video of the adult down syndrome center', 'interventionNames': ['Behavioral: Verbal instructions with video of ADSC']}, {'type': 'OTHER', 'label': 'verbal instructions w. video of w/o DS', '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.', 'interventionNames': ['Behavioral: verbal instructions w. video of w/o DS']}, {'type': 'OTHER', 'label': 'verbal instructions w.video w/DS', '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.', 'interventionNames': ['Behavioral: verbal instructions w. video w/DS']}], 'interventions': [{'name': 'Verbal instructions with picture diagram', 'type': 'BEHAVIORAL', 'description': 'verbal instructions and picture diagram', 'armGroupLabels': ['Verbal instructions with picture diagram']}, {'name': 'Verbal instructions with video of ADSC', 'type': 'BEHAVIORAL', 'description': 'Verbal instructions and watching video depicting ADSC', 'armGroupLabels': ['Verbal instructions with video of ADSC']}, {'name': 'verbal instructions w. video of w/o DS', 'type': 'BEHAVIORAL', 'description': 'verbal instructions and watching video depicting person without DS washing her hands', 'armGroupLabels': ['verbal instructions w. video of w/o DS']}, {'name': 'verbal instructions w. video w/DS', 'type': 'BEHAVIORAL', 'description': 'verbal instructions and watching video depicting person with DS washing his hands', 'armGroupLabels': ['verbal instructions w.video w/DS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Adult Down Syndrome Center / Russell Institute for Research and Innovation', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}], 'overallOfficials': [{'name': 'Brian Chicoine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advocate Health and Hospitals Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}