Infection Control TrainingNCT02856529
Effects of Basic Infection Control Skills License on Knowledge and Practice of Health Care Workers
A study testing Training and General session in people with Infection Control Training, run by Madinah Saudi Board Community Medicine.
Trial summary
Considering the importance of infection control practices, Madinah Public Health Department launched a new license program for healthcare workers, the Basic Infection Control Skills License program (BICSL). BICSL has been launched to train healthcare workers all over the region in a scientific standardized way. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection Control Training
- What is being tested?
- Training and General session
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working in the chosen hospitals.
- Health care worker (Physician, nurse or technician) of any gender, age, or experience.
Who cannot join
- Refuse to participate in the study.
- Have BICSL certificate before the study implemented.
- On leave during study period.
About this study
Considering the importance of infection control practices, Madinah Public Health Department launched a new license program for healthcare workers, the Basic Infection Control Skills License program (BICSL). BICSL has been launched to train healthcare workers all over the region in a scientific standardized way.
To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable questionnaire will be used to evaluate the workers knowledge and practices before and after three and six months of the intervention. The knowledge and practice answers were scored and the scores were categorized to facilitate the comparison. A BICSL certified trainer will be conducting the intervention, a one to one training session. A SPSS program will be used to analyze the data. Administrative and ethical approval was obtained from Madinah health authority. The participants will complete an electronic consent before they fill the questionnaire. Confidentiality and privacy as well as freedom to participate or not will be insured to all participants. This study will assess the license effectiveness in improve knowledge and compliance.
- Conditions
- Infection Control Training
- Being tested
- Training, General session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
The Basic Infection Control Skills License program (BICSL) includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator. Also, the license program includes training on hand hygiene and the use of personal protective equipment (PPE). To get the license, each participants must get the vaccination and attend one to one training session with a program trainer 34.
General sessionOther
A general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A BICSL certified trainer conduct the intervention. It includes hand on training session standardized in a scientific way. The participants trained on hand hygiene and use of PPE. Also, it includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator. Receives: Other: Training |
| Control | Active comparator | A general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill. Receives: Other: General session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self administered knowledge
will be measured by questionnaire
Measured: 3 months
Self administered practice
will be measured by questionnaire
Measured: 3 months
Secondary outcomes (2)
Self administered knowledge
between different sexes and professions, it will be measured by questionnaire
Measured: 3 months
Self administred practices
between different sexes and professions, it will be measured by questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Control TrainingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madinah Saudi Board Community Medicine
- Sponsor type
- Other government
- Collaborators
- Madinah directorate - Ministry of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856529
- Sponsor's protocol ID
- SBCMM001
- Status last verified
- Jul 2016
- First submitted
- 18 Jun 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Basic Infection Control Skills License on Knowledge and Practice of Health Care Workers
- ClinicalTrials.gov ID
- NCT02856529
- Acronym / sponsor ID
- SBCMM001
- Conditions
- Infection Control Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Madinah Saudi Board Community MedicineOther government
- Collaborators
- Madinah directorate - Ministry of Health
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Aug 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.
Considering the importance of infection control practices, Madinah Public Health Department launched a new license program for healthcare workers, the Basic Infection Control Skills License program (BICSL). BICSL has been launched to train healthcare workers all over the region in a scientific standardized way.
To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable questionnaire will be used to evaluate the workers knowledge and practices before and after three and six months of the intervention. The knowledge and practice answers were scored and the scores were categorized to facilitate the comparison. A BICSL certified trainer will be conducting the intervention, a one to one training session. A SPSS program will be used to analyze the data. Administrative and ethical approval was obtained from Madinah health authority. The participants will complete an electronic consent before they fill the questionnaire. Confidentiality and privacy as well as freedom to participate or not will be insured to all participants. This study will assess the license effectiveness in improve knowledge and compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: TrainingA BICSL certified trainer conduct the intervention. It includes hand on training session standardized in a scientific way. The participants trained on hand hygiene and use of PPE. Also, it includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator. |
| Control | Active comparator | Other: General sessionA general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Working in the chosen hospitals.
- Health care worker (Physician, nurse or technician) of any gender, age, or experience.
Key exclusion criteria (3 listed)
- Refuse to participate in the study.
- Have BICSL certificate before the study implemented.
- On leave during study period.
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 |
|---|---|---|
| TrainingThe Basic Infection Control Skills License program (BICSL) includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator. Also, the license program includes training on hand hygiene and the use of personal protective equipment (PPE). To get the license, each participants must get the vaccination and attend one to one training session with a program trainer 34. | Other | Intervention |
| General sessionA general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill. | Other | Control |
Primary outcome
Self administered knowledge
Time frame: 3 months
will be measured by questionnaire
Self administered practice
Time frame: 3 months
will be measured by questionnaire
2 secondary outcomes
Self administered knowledge
Time frame: 3 months
Self administred practices
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Training and General session in people with Infection Control Training, run by Madinah Saudi Board Community Medicine.
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 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: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Self administered knowledge (time frame: 3 months). The study lists 2 primary outcomes in all. 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 5 Aug 2016.