Down SyndromeNCT02895802
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)
A study testing Verbal instructions with picture diagram, Verbal instructions with video of ADSC and verbal instructions w. video of w/o DS in people with Down Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Verbal instructions with picture diagram, Verbal instructions with video of ADSC and verbal instructions w. video of w/o DS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People with Down syndrome receiving care at Advocate
- No known sensitivity to soap
Who cannot join
- Pregnant women, prisoners
- Known sensitivity to soap
Trial locations and contacts
1 site in 1 country.
United States1 site
Adult Down Syndrome Center / Russell Institute for Research and Innovation
Park Ridge, Illinois, 60068
About this study
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.
Read the detailed description
The subjects will be recruited and identified and consented. Subjects will be randomized to one of 4 groups.
- 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.
- Conditions
- Down Syndrome
- Being tested
- 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
- Keywords
- down syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal instructions with picture diagramBehavioural
verbal instructions and picture diagram
Verbal instructions with video of ADSCBehavioural
Verbal instructions and watching video depicting ADSC
verbal instructions w. video of w/o DSBehavioural
verbal instructions and watching video depicting person without DS washing her hands
verbal instructions w. video w/DSBehavioural
verbal instructions and watching video depicting person with DS washing his hands
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: Behavioral: verbal instructions w. video w/DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Chicoine, MD, Principal investigator, Advocate Health and Hospitals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895802
- Sponsor's protocol ID
- 6360
- Status last verified
- Jan 2019
- First submitted
- 27 Aug 2016
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 21352207Parker 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.
PubMed 12889762Lee 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.
PubMed 25124699Kagohara 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.
PubMed 22940168Global 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.
PubMed 10586155
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS)
- ClinicalTrials.gov ID
- NCT02895802
- Acronym / sponsor ID
- 6360
- Conditions
- Down Syndrome
- Keywords
- down syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Verbal instructions with picture diagram | Other | Behavioral: Verbal instructions with picture diagramhand washing is scored prior and after educational intervention with verbal instructions of handwashing and a picture diagram of handwashing. |
| Verbal instructions with video of ADSC | Other | Behavioral: Verbal instructions with video of ADSChand washing is scored prior and after educational intervention with verbal instructions of handwashing and a video of the adult down syndrome center |
| verbal instructions w. video of w/o DS | Other | Behavioral: verbal instructions w. video of w/o DShand 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 w.video w/DS | Other | Behavioral: verbal instructions w. video w/DShand 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People with Down syndrome receiving care at Advocate
- No known sensitivity to soap
Key exclusion criteria (2 listed)
- Pregnant women, prisoners
- Known sensitivity to soap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal instructions with picture diagramverbal instructions and picture diagram | Behavioural | Verbal instructions with picture diagram |
| Verbal instructions with video of ADSCVerbal instructions and watching video depicting ADSC | Behavioural | Verbal instructions with video of ADSC |
| verbal instructions w. video of w/o DSverbal instructions and watching video depicting person without DS washing her hands | Behavioural | verbal instructions w. video of w/o DS |
| verbal instructions w. video w/DSverbal instructions and watching video depicting person with DS washing his hands | Behavioural | verbal instructions w.video w/DS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Results publication: PubMed 21352207Ram 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 publication: PubMed 12889762Parker 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 publication: PubMed 25124699Lee 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 publication: PubMed 22940168Kagohara 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 publication: PubMed 10586155Global 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.
- Individual participant dataSharing planned: No
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Chicoine, MD principal investigator
Advocate Health and Hospitals Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal instructions with picture diagram, Verbal instructions with video of ADSC and verbal instructions w. video of w/o DS in people with Down Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on handwashing checklist (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895802, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.