Illness AbsenteeismPhase 3JHSNCT00610376
Jerusalem Handwashing Study
A Phase 3 study testing Preschool handwashing intervention program and Home component intervention in people with Illness Absenteeism and Handwashing Behavior, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
The primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Illness Absenteeism, Handwashing Behavior
- What is being tested?
- Preschool handwashing intervention program and Home component intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2000to Dec 2001
- Phase
- Phase 3
- 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool teachers of 3- and 4-year-old children in the state-run public system of the Jerusalem region, who were recommended by their supervisors as being likely to comply with the protocol.
Who cannot join
- Exposure to project during testing phase (N=1 preschool), preschool which included new Ethiopian immigrants who were unlikely to have phones or speak Hebrew (N=1 preschool)
- Project staff knew teachers personally and thought they would not comply with protocol (N=2 teachers).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Trial to Assess the Effect of a Health Promotion Intervention on Hygiene Behavior and Illness Absenteeism in Jerusalem Preschools
The primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism.
Read the detailed description
Please see citations of published reports.
- Conditions
- Illness Absenteeism, Handwashing Behavior
- Being tested
- Preschool handwashing intervention program, Home component intervention
- Keywords
- Handwashing, Randomized controlled trial, Cluster randomization, Community intervention trial, Disease prevention, Pediatric communicable disease, Preschool, Illness absenteeism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preschool handwashing intervention programBehavioural
This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.
Home component interventionBehavioural
The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | Preschools randomized to this group received a multicomponent intervention to improve handwashing behavior of the children. Children within the preschool intervention group were individually randomized to a home intervention or a home control intervention program. The children in this arm received the home intervention component. Receives: Behavioral: Preschool handwashing intervention program; Behavioral: Home component intervention |
| 2 | Active comparator | This group did not receive any special treatment during the study, but did receive the intervention at the close of the study Receives: Behavioral: Preschool handwashing intervention program |
| 1B | Experimental | Preschools randomized to this group received a multicomponent intervention to improve handwashing behavior of the children. Children within the preschool intervention group were individually randomized to a home intervention or a home control intervention program. The children in this arm received the home control component. Receives: Behavioral: Preschool handwashing intervention program; Behavioral: Home component intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness absenteeism
Measured: Each school day during study period
Secondary outcomes (1)
Handwashing behavior
Measured: Observational visits in classrooms (3-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startSep 2000
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Illness AbsenteeismStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Israel, Hadassah Medical Organization, Israel National Institute for Health Policy and Health Services Research, Ministry of Education, Israel, Municipality of Jerusalem, Israel
- Investigators
- Laura J Rosen, PhD, Principal investigator, Hebrew University (at time of study)David M Zucker, PhD, Principal investigator, Hebrew UniversityOrly Manor, PhD, Principal investigator, Hebrew UniversityDan Engelhard, MD, Principal investigator, Hadassah Hebrew Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610376
- Sponsor's protocol ID
- JHS1
- Other IDs
- NIHP Doctoral Stipend [m-2-02]
- Acronym
- JHS
- Status last verified
- Jan 2008
- First submitted
- 27 Jan 2008
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosen L, Manor O, Engelhard D, Brody D, Rosen B, Peleg H, Meir M, Zucker D. Can a handwashing intervention make a difference? Results from a randomized controlled trial in Jerusalem preschools. Prev Med. 2006 Jan;42(1):27-32. doi: 10.1016/j.ypmed.2005.09.012. Epub 2005 Nov 21.
PubMed 16300823Rosen L, Manor O, Engelhard D, Zucker D. Design of the Jerusalem Handwashing Study: meeting the challenges of a preschool-based public health intervention trial. Clin Trials. 2006;3(4):376-84. doi: 10.1177/1740774506070690.
PubMed 17060212Rosen L, Manor O, Engelhard D, Zucker D. In defense of the randomized controlled trial for health promotion research. Am J Public Health. 2006 Jul;96(7):1181-6. doi: 10.2105/AJPH.2004.061713. Epub 2006 May 30.
PubMed 16735622
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial to Assess the Effect of a Health Promotion Intervention on Hygiene Behavior and Illness Absenteeism in Jerusalem Preschools
- ClinicalTrials.gov ID
- NCT00610376
- Acronym / sponsor ID
- JHS / JHS1
- Conditions
- Illness Absenteeism, Handwashing Behavior
- Keywords
- Handwashing, Randomized controlled trial, Cluster randomization, Community intervention trial, Disease prevention, Pediatric communicable disease, Preschool, Illness absenteeism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Ministry of Health, Israel, Hadassah Medical Organization, Israel National Institute for Health Policy and Health Services Research, Ministry of Education, Israel, Municipality of Jerusalem, Israel
- Study start
- Sep 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 8 Feb 2008 (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.
The primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism.
Detailed description
Please see citations of published reports.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Behavioral: Preschool handwashing intervention program, Behavioral: Home component interventionPreschools randomized to this group received a multicomponent intervention to improve handwashing behavior of the children. Children within the preschool intervention group were individually randomized to a home intervention or a home control intervention program. The children in this arm received the home intervention component. |
| 2 | Active comparator | Behavioral: Preschool handwashing intervention programThis group did not receive any special treatment during the study, but did receive the intervention at the close of the study |
| 1B | Experimental | Behavioral: Preschool handwashing intervention program, Behavioral: Home component interventionPreschools randomized to this group received a multicomponent intervention to improve handwashing behavior of the children. Children within the preschool intervention group were individually randomized to a home intervention or a home control intervention program. The children in this arm received the home control component. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preschool teachers of 3- and 4-year-old children in the state-run public system of the Jerusalem region, who were recommended by their supervisors as being likely to comply with the protocol.
Key exclusion criteria (2 listed)
- Exposure to project during testing phase (N=1 preschool), preschool which included new Ethiopian immigrants who were unlikely to have phones or speak Hebrew (N=1 preschool)
- Project staff knew teachers personally and thought they would not comply with protocol (N=2 teachers).
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 |
|---|---|---|
| Preschool handwashing intervention programThis preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment. | Behavioural | 1A, 1B, 2 |
| Home component interventionThe home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card. | Behavioural | 1A, 1B |
Primary outcome
Illness absenteeism
Time frame: Each school day during study period
1 secondary outcome
Handwashing behavior
Time frame: Observational visits in classrooms (3-4)
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 22 Sep 2015.
- Background: PubMed 16300823Rosen L, Manor O, Engelhard D, Brody D, Rosen B, Peleg H, Meir M, Zucker D. Can a handwashing intervention make a difference? Results from a randomized controlled trial in Jerusalem preschools. Prev Med. 2006 Jan;42(1):27-32. doi: 10.1016/j.ypmed.2005.09.012. Epub 2005 Nov 21.
- Background: PubMed 17060212Rosen L, Manor O, Engelhard D, Zucker D. Design of the Jerusalem Handwashing Study: meeting the challenges of a preschool-based public health intervention trial. Clin Trials. 2006;3(4):376-84. doi: 10.1177/1740774506070690.
- Background: PubMed 16735622Rosen L, Manor O, Engelhard D, Zucker D. In defense of the randomized controlled trial for health promotion research. Am J Public Health. 2006 Jul;96(7):1181-6. doi: 10.2105/AJPH.2004.061713. Epub 2006 May 30.
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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.
Laura J Rosen, PhD principal investigator
Hebrew University (at time of study)
David M Zucker, PhD principal investigator
Hebrew University
Orly Manor, PhD principal investigator
Hebrew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preschool handwashing intervention program and Home component intervention in people with Illness Absenteeism and Handwashing Behavior, run by Hebrew University of Jerusalem at 1 site in Israel.
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 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 22 Sep 2015. 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Illness absenteeism (time frame: Each school day during study period). 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 NCT00610376, which also lists 3 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 22 Sep 2015.