Down SyndromeNCT03551418
Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome
A study testing Watching a video in people with Down Syndrome and Trisomy 21, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied. 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, Trisomy 21
- What is being tested?
- Watching a video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2018to 16 Aug 2020
- 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
- Individuals with:
- DS aged 18 and older
- The ability to use a checklist or to be taught how to use a checklist
- The ability to use a tablet or to be taught how to use a tablet
- Access to an Internet connection
Who cannot join
- Individuals who:
- Are not yet adults
- Are unwilling to consent and/or assent
- Are unable or unwilling to return the ADSC for the 1 month and 2 months follow up visits
- 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
The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied.
Read the detailed description
This study is a next step in evaluating the use of videos depicting a person with DS demonstrating hand washing. The initial study demonstrated improvement in hand washing technique with a verbal explanation of hand washing technique using an Illinois Department of Public Health handout and viewing one of the handwashing videos one time. The study demonstrated a statistical significant difference between learning by viewing the handout and a video of an adult with DS washing his hands vs just viewing the handout.viewing a handout Likely due to small sample size, the study did not demonstrate statistical significance between watching the video of a person with DS washing his hands vs watching the other videos but the trend for the best improvement in handwashing technique was for the group viewing another person with DS demonstrating the handwashing. The hypothesis of this study is that repeated viewing of a video and practicing hand washing will lead to even greater improvement in hand washing technique.
- Conditions
- Down Syndrome, Trisomy 21
- Being tested
- Watching a video
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching a videoBehavioural
Watching a video of an adult with DS washing his hands
| Study group | Role | What they receive |
|---|---|---|
| Repetitive video watching | Experimental | Repetitively watching a video of an adult with Down Syndrome washing his hands Receives: Behavioral: Watching a video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate hand washing technique
Measuring appropriate replicating of standard hand washing technique using a standard check list
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start9 Jun 2018
- Primary completion16 Aug 2020
- Study completion16 Aug 2020
Why it stopped: Interruption of COVID 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551418
- Sponsor's protocol ID
- AHC IRB 6884
- Status last verified
- Oct 2024
- First submitted
- 29 May 2018
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome
- ClinicalTrials.gov ID
- NCT03551418
- Acronym / sponsor ID
- AHC IRB 6884
- Conditions
- Down Syndrome, Trisomy 21
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interruption of COVID 19 pandemic
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 9 Jun 2018 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 16 Aug 2020 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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.
The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied.
Detailed description
This study is a next step in evaluating the use of videos depicting a person with DS demonstrating hand washing. The initial study demonstrated improvement in hand washing technique with a verbal explanation of hand washing technique using an Illinois Department of Public Health handout and viewing one of the handwashing videos one time. The study demonstrated a statistical significant difference between learning by viewing the handout and a video of an adult with DS washing his hands vs just viewing the handout.viewing a handout Likely due to small sample size, the study did not demonstrate statistical significance between watching the video of a person with DS washing his hands vs watching the other videos but the trend for the best improvement in handwashing technique was for the group viewing another person with DS demonstrating the handwashing. The hypothesis of this study is that repeated viewing of a video and practicing hand washing will lead to even greater improvement in hand washing technique.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repetitive video watching | Experimental | Behavioral: Watching a videoRepetitively watching a video of an adult with Down Syndrome washing his hands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DS aged 18 and older
- The ability to use a checklist or to be taught how to use a checklist
- The ability to use a tablet or to be taught how to use a tablet
- Access to an Internet connection
Key exclusion criteria (5 listed)
- Are not yet adults
- Are unwilling to consent and/or assent
- Are unable or unwilling to return the ADSC for the 1 month and 2 months follow up visits
- 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 |
|---|---|---|
| Watching a videoWatching a video of an adult with DS washing his hands | Behavioural | Repetitive video watching |
Primary outcome
Appropriate hand washing technique
Time frame: 2 months
Measuring appropriate replicating of standard hand washing technique using a standard check list
Results and safety
The study was stopped early (reason given: Interruption of COVID 19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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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
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching a video in people with Down Syndrome and Trisomy 21, 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Nov 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 was stopped early (reason given: Interruption of COVID 19 pandemic). Results are not available in the source record.
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?
Appropriate hand washing technique (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.