Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000091202
Ethics application status
Approved
Date submitted
11/09/2017
Date registered
19/01/2018
Date last updated
19/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of health education on recurrent infestation with head lice
Scientific title
Effectiveness of a school-based educational intervention on knowledge, attitude, and practices associated with Pediculosis capitis re-infestation
Secondary ID [1] 292849 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediculosis capitis (head lice infestation) 304692 0
Condition category
Condition code
Public Health 304001 304001 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the children with head lice in both control and intervention groups will be treated with pediculicide. The pediculicide that will be used is "Lice Clear" by Apex Pharma (Malaysia). It contains 4% Dimeticone, packed in a 75ml bottle. A plastic lice comb is also included in the packaging. They will applpy the pediculicide 2 times, 7 days apart. Methods of application is available in a printed form and will be supplied to all the students with head lice.


On top of the application of pediculicide, the intervention group will be given health education on Head lice infestation, prevention, and management.

The intervention is formulated based on the pilot study that was conducted on the knowledge, attitude and practices associated with Pediculosis capitis infestation and reinfestation among the primary school children in Hulu Langat District, Selangor, Malaysia. The intervention is aimed to:
i) improve knowledge of the students on Pediculosis capitis infestation particularly on identifying the head lice, recognizing the symptoms of infestation, diagnosis, prevention and management.
ii) encourage good behavior in preventing Pediculosis capitis infestation and reinfestation.
iii) instill good practices in the prevention and management of Pediculosis capitis infestation and reinfestation.

The intervention group receives the health education module whereas the control group is waitlisted and receives the similar health intervention module when the study period of the intervention group has been completed (after 6 weeks from the first visit by the researcher).

Contamination between the intervention and control groups is limited and controlled. This will be achieved via limiting interaction of the respondents by selecting two schools that are apart.

The health education module will consist of the followings:
a) One session of health talk, approximately 45minutes of health talk and 30 minutes of Q&A session. The health talk will be delivered by the researcher, a doctor who holds a master degree in Public Health (MPH).
The health talk will be given in the schools. It is intended for all students, especially for those with head lice intervention. However, the teachers or parents are also welcomed to attend.

b) Printed brochures on head lice management and prevention for each student to be brought home.
The printed materials will also be made available on the school notice board and Health Room.

c) Focus Group Discussion on head lice management and prevention for students with head lice at the time of inspection.
Each session is allocated for each school in the intervention group. Each session will last for approximately 2 hours. The students will be assessed on their knowledge, attitude, and practices in the management and prevention of head lice. They will be encouraged to share their difficulty, concern, and challenges in dealing with head lice infestation. Appropriate advice will be given accordingly.
Intervention code [1] 299094 0
Prevention
Intervention code [2] 299351 0
Treatment: Other
Comparator / control treatment
The control group will be waitlisted and received the similar health intervention module received by the intervention group when the study period is completed (i.e waitlist control group will be offered the intervention after 6 weeks from the first visit by the researcher).
Control group
Active

Outcomes
Primary outcome [1] 303336 0
Knowledge about Pediculosis capitis infestation assessed by the knowledge section of the questionnaire.

The questionnaires that will be used has been designed specifically for this study.
Timepoint [1] 303336 0
at baseline and two weeks after intervention
Primary outcome [2] 303337 0
Attitude towards Pediculosis capitis infestation assessed by the attitude section of the questionnaire.

The questionnaire has been designed specifically for this study.
Timepoint [2] 303337 0
at baseline and two weeks after intervention
Primary outcome [3] 303624 0
Practices towards Pediculosis capitis infestation assessed by the practices section of the questionnaire.

The questionnaire has been designed specifically for this study.
Timepoint [3] 303624 0
At baseline and two weeks after intervention
Secondary outcome [1] 338672 0
Re-infestation rate of Pediculosis capitis after successful eradication
This is determined by the level of re-infestation with Pediculosis capitis measured at six weeks after successful eradication among the respondents.
The desired outcome was the elimination of head lice using two applications of treatment, seven days apart. All participants were examined by dry detection combing, six weeks after successful eradication to check for the presence of lice or eggs. It was determined using the following formula:
Re-infestation of Pediculosis capitis (N%)
= Number of students re-infested at 6-weeks after successful eradication x 100
-----------------------------------------------------------
Number of students had successful eradication 2 weeks after applying pediculicides
Timepoint [1] 338672 0
six weeks after successful eradication of head lice among the respondents.
Secondary outcome [2] 339682 0
Prevalence of Pediculosis capitis.

All participants were examined by visual inspection using dry combing method, to check for the presence of lice or eggs. It was determined using the following formula:
Prevalence of Pediculosis capitis (N%)
= Number of students infested x 100
-------------------------------------------
Number of students screened at baseline

(Note : This is the fourth primary outcome)
Timepoint [2] 339682 0
At baseline

Eligibility
Key inclusion criteria
1. All standard four and five students in the selected government primary schools in Hulu Langat district with Pediculosis capitis infestation.
2. Consented by the parents or caregivers and the students to participate in this study.
3. The student was available throughout the whole duration of data collection.
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The students who were attending special education classes.
2. Participation in another clinical study within one month before entry to this study.
3. Usage of any pediculicide at the time of data collection or for the whole or partial duration of one month prior to the data collection.
4. Active scalp infection or scalp lesions such as psoariasis or eczema.
5. Allergic to any ingredient of the pediculicide based on the information provided by the parents.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation of the schools into intervention and control group is carried out by an independent statistician who does not involve in this study.
All the schools were assigned a number starting from one to 87. An online random number generator was used (http://stattrek.com/statistics/random-number-generator.aspx). The ten numbers generated were matched with the number assigned to each school. The first five schools identified from the random number generator are classified as intervention group, and the remaining five schools are in the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software for computerised sequence generation.
(http://stattrek.com/statistics/random-number-generator.aspx)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis was done by using Statistical Package for Social Sciences version 22 (SPSS Inc, Chicago, IL, USA). After all the data were entered, data cleaning was carried out to identify any error during data entry. Descriptive statistics was carried out to determine the socio-demographic distribution of respondents between the intervention and control groups. The description was given in frequency and percentage.

Socio-demographic characteristics for both groups were compared using chi-square test or fisher exact’s test to determine the association of respondents of both groups. The prevalence of Pediculosis capitis was given in frequency and percentage. For 2x2 table that contained cell with expected count less than 5, Fischer’s Exact test was used to determine the association between the groups. To assess changes from baseline to post-intervention, Paired t-test or Wilcoxon signed-rank test was applied for continuous data.

Descriptive statistical analysis was used to provide information about respondents’ knowledge, attitude and practices. Considering normal distribution of knowledge and attitude subscales as dependent variables, mean and standard deviations were computed for each subscale of knowledge and attitude.

To determine the significant factors which determine the absence or presence of Pediculosis capitis, multiple logistic regression was used. Continuous independent variables such as knowledge, attitude and practices subscales were entered as predictor factors in a logistic regression model.

Mc Nemar’s test was conducted as the same individuals were measured thrice (baseline, immediate and 6-weeks after the intervention) to evaluate the impact of an education programme on three recurrent themes of Pediculosis capitis between baseline and post-intervention: 1) Knowledge 2) Attitude 3) Practices.

A Multi-Level Modelling (Generalised Linear Mixed Model) analysis was employed to look at the main and interaction effects within and between groups for all the continuous & categorical dependant variables. This is to ensure that all possible contextual variables of different levels were considered in the analysis. This was done to ensure that the clustering effect is considered during the analysis to come to the most accurate inferential statistical results.

Due to the complexity of this study where multiple continuous and categorical dependent variables was measured repeatedly at two different time with possible large variation in the distribution of mean scores across a huge sample size of thousands of study subjects, a more complex analysis in the form of Generalized Liner Mixed Model is required. The analysis is also able to control and adjust for the clustering effect of the schools and treatment groups by identifying and classifying both as the contextual variables during the analysis to yield a more accurate result. In principle, generalized linear mixed model extends the linear model so that:
i. The target is linearly related to the factors and covariates via a specified link function.
ii. The target can have a non-normal distribution.
iii. The observations can be correlated.

Generalized linear mixed models cover a wide variety of models, from simple linear regression to complex multilevel models for non-normal longitudinal data, making it the most suitable type of analysis for this study. Generalized Linear Mixed model includes both the fixed effects and random intercepts in the model. Treatment group (intervention or control) and individual study subjects was included as the Contextual Variables and adjusted accordingly in the analysis. Main Dependent Variable in this study is the mean knowledge score for baseline and after the intervention while secondary dependent variables are the prevalence of Pediculosis capitis before and after the usage of pediculicide. The final model was decided based on effect of entering and removing independent variables and covariates into the model on the Akaike Corrected & Bayesian index. Models with smaller information criterion values fits better.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/08/2017
Date of last participant enrolment
Anticipated
Actual
29/08/2017
Date of last data collection
Anticipated
Actual
13/10/2017
Sample size
Target
300
Accrual to date
Final
297
Recruitment outside Australia
Country [1] 9189 0
Malaysia
State/province [1] 9189 0
Selangor

Funding & Sponsors
Funding source category [1] 297482 0
University
Name [1] 297482 0
UNIVERSITI PUTRA MALAYSIA
Country [1] 297482 0
Malaysia
Primary sponsor type
University
Name
UNIVERSITI PUTRA MALAYSIA
Address
Universiti Putra Malaysia, Jalan UPM, 43400 Serdang, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 296479 0
None
Name [1] 296479 0
Address [1] 296479 0
Country [1] 296479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298584 0
UNIVERSITI PUTRA MALAYSIA ETHICS COMMITTEE
Ethics committee address [1] 298584 0
Ethics committee country [1] 298584 0
Malaysia
Date submitted for ethics approval [1] 298584 0
14/09/2016
Approval date [1] 298584 0
16/01/2017
Ethics approval number [1] 298584 0
FPSK(EXP16)P163

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77558 0
Dr Nor Faiza Mohd. Tohit
Address 77558 0
Dept. of Community Medicine
Faculty of Medicines and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 77558 0
Malaysia
Phone 77558 0
+60389472606
Fax 77558 0
Email 77558 0
[email protected]
Contact person for public queries
Name 77559 0
Nor Faiza Mohd. Tohit
Address 77559 0
Dept. of Community Medicine
Faculty of Medicines and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 77559 0
Malaysia
Phone 77559 0
+60389472606
Fax 77559 0
Email 77559 0
[email protected]
Contact person for scientific queries
Name 77560 0
Dr. Lekhraj Rampal
Address 77560 0
Dept. of Community Medicine
Faculty of Medicines and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 77560 0
Malaysia
Phone 77560 0
+6038947 2411
Fax 77560 0
Email 77560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.