Intervention in Hand Hygiene for Infectious Diseases PreventionNCT07160842
Impact of an AI-enabled UV Hand Hygiene Intervention in Primary Schools: a Community Intervention Study
A study testing Hand hygiene intervention in people with Intervention in Hand Hygiene for Infectious Diseases Prevention, run by Institut Catala de Salut at 1 site in Spain.
Trial summary
Background Hand hygiene refers to the practice of keeping hands clean to prevent the spread of disease. Hand hygiene workshops are an important tool to educate students about the importance of keeping their hands clean and healthy. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention in Hand Hygiene for Infectious Diseases Prevention
- What is being tested?
- Hand hygiene intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2024to 1 Oct 2024
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students attending third- to sixth-grade of enrolled primary school
Who cannot join
- physical or intellectual disabilities precluding correct hand hygiene
- allergy/contraindication to alcohol-based hand rub (ABHR)
- <80% school attendance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a School-based Educational Intervention That Combined a Structured Training Session With a Fluorescence-enabled Device on the Quality of Students' Hand Hygiene at 1, 3 and 6 Months Post Intervention
Background Hand hygiene refers to the practice of keeping hands clean to prevent the spread of disease. Hand hygiene workshops are an important tool to educate students about the importance of keeping their hands clean and healthy.
Objectives The primary objective of this project is to evaluate the effectiveness of an educational intervention previously used in other settings that incorporates a fluorescence-based device to quantify the quality of hand hygiene in real time, together with a training workshop for students, with the aim of improving health promotion and prevention in the short and medium term (1, 3, and 6 months).
Read more
Methods This is a sub-study of the Sentinel Schools Project. It is a controlled before-after study with school level allocation using a single matched pair (1 intervention school; 1 control school) and repeated measures conducted in schools belonging to the Sentinel Schools network within the Camp de Tarragona health region. The study population comprises students enrolled in primary education at these schools. The project field team carried out a pre-intervention assessment of handwashing quality in both study arms using a device that uses fluorescence to detect adequately washed areas of the hand. In the intervention arm, an educational training session on hand hygiene was delivered, followed by post-intervention assessments at short and medium term in both study arms. To examine the acceptability of the intervention, an ad hoc questionnaire was administered to the teachers who supervise the participating classes and also focal groups and enterprises were made to access the acceptability of the intervention.
Statistical Analysis Frequencies and percentages will be calculated for qualitative variables; for quantitative variables, the mean and standard deviation, as well as minimum and maximum values, will be reported. Ninety-five percent confidence intervals will be presented for means and for proportions. Bivariate analyses for quantitative variables will be performed, estimating Pearson correlation coefficients and/or linear regression.
- Being tested
- Hand hygiene intervention
- Keywords
- hand hygiene, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand hygiene interventionBehavioural
The educational intervention consisted of a two-part training session: (i) a thirty-minute didactic session introducing the 7-step alcohol-based hand rub (ABHR) technique (14), the importance of proper hand hygiene for infection prevention; and (ii) a practical component on hand hygiene with real-time feedback.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The educational intervention consisted of a two-part training session: (i) a thirty-minute didactic session introducing the 7-step alcohol-based hand rub (ABHR) technique (14), the importance of proper hand hygiene for infection prevention; and (ii) a practical component on hand hygiene with real-time feedback Receives: Behavioral: Hand hygiene intervention |
| Control group | No intervention | The control group received the hand hygiene evaluation visits without the educational session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of hand surface area correctly washed
The percentage of clean hand surface area, defined as the proportion of the total hand that was adequately covered with hand rub
Measured: From enrollment to the end of the evaluation visits at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention in Hand Hygiene for Infectious Diseases PreventionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Catala de Salut
- Sponsor type
- Other government
- Collaborators
- CEEISCAT, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Responsible party
- Principal investigator, Anna Bordas, Institut Catala de Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160842
- Sponsor's protocol ID
- Handhygiene_sentinelschools
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared. This trial was conducted in schools with minors, and informed consent did not include permission to share de-identified IPD beyond the study team. In alignment with ethical approvals and applicable data protection regulations, only aggregate results will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a School-based Educational Intervention That Combined a Structured Training Session With a Fluorescence-enabled Device on the Quality of Students' Hand Hygiene at 1, 3 and 6 Months Post Intervention
- ClinicalTrials.gov ID
- NCT07160842
- Acronym / sponsor ID
- Handhygiene_sentinelschools
- Keywords
- hand hygiene, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Institut Catala de SalutOther government
- Collaborators
- CEEISCAT, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Sep 2025 (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.
Background Hand hygiene refers to the practice of keeping hands clean to prevent the spread of disease. Hand hygiene workshops are an important tool to educate students about the importance of keeping their hands clean and healthy.
Objectives The primary objective of this project is to evaluate the effectiveness of an educational intervention previously used in other settings that incorporates a fluorescence-based device to quantify the quality of hand hygiene in real time, together with a training workshop for students, with the aim of improving health promotion and prevention in the short and medium term (1, 3, and 6 months).
Methods This is a sub-study of the Sentinel Schools Project. It is a controlled before-after study with school level allocation using a single matched pair (1 intervention school; 1 control school) and repeated measures conducted in schools belonging to the Sentinel Schools network within the Camp de Tarragona health region. The study population comprises students enrolled in primary education at these schools. The project field team carried out a pre-intervention assessment of handwashing quality in both study arms using a device that uses fluorescence to detect adequately washed areas of the hand. In the intervention arm, an educational training session on hand hygiene was delivered, followed by post-intervention assessments at short and medium term in both study arms. To examine the acceptability of the intervention, an ad hoc questionnaire was administered to the teachers who supervise the participating classes and also focal groups and enterprises were made to access the acceptability of the intervention.
Statistical Analysis Frequencies and percentages will be calculated for qualitative variables; for quantitative variables, the mean and standard deviation, as well as minimum and maximum values, will be reported. Ninety-five percent confidence intervals will be presented for means and for proportions. Bivariate analyses for quantitative variables will be performed, estimating Pearson correlation coefficients and/or linear regression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Hand hygiene interventionThe educational intervention consisted of a two-part training session: (i) a thirty-minute didactic session introducing the 7-step alcohol-based hand rub (ABHR) technique (14), the importance of proper hand hygiene for infection prevention; and (ii) a practical component on hand hygiene with real-time feedback |
| Control group | No intervention | –The control group received the hand hygiene evaluation visits without the educational session |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- students attending third- to sixth-grade of enrolled primary school
Key exclusion criteria (3 listed)
- physical or intellectual disabilities precluding correct hand hygiene
- allergy/contraindication to alcohol-based hand rub (ABHR)
- <80% school attendance.
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 |
|---|---|---|
| Hand hygiene interventionThe educational intervention consisted of a two-part training session: (i) a thirty-minute didactic session introducing the 7-step alcohol-based hand rub (ABHR) technique (14), the importance of proper hand hygiene for infection prevention; and (ii) a practical component on hand hygiene with real-time feedback. | Behavioural | Intervention group |
Primary outcome
Percentage of hand surface area correctly washed
Time frame: From enrollment to the end of the evaluation visits at 6 months
The percentage of clean hand surface area, defined as the proportion of the total hand that was adequately covered with hand rub
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 8 Sep 2025.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared. This trial was conducted in schools with minors, and informed consent did not include permission to share de-identified IPD beyond the study team. In alignment with ethical approvals and applicable data protection regulations, only aggregate results will be made publicly available.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand hygiene intervention in people with Intervention in Hand Hygiene for Infectious Diseases Prevention, run by Institut Catala de Salut at 1 site in Spain.
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 1 inclusion and 3 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 8 Sep 2025. 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 Spain. 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?
Percentage of hand surface area correctly washed (time frame: From enrollment to the end of the evaluation visits at 6 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 8 Sep 2025.