Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000231640
Ethics application status
Approved
Date submitted
26/02/2014
Date registered
5/03/2014
Date last updated
10/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised trial of an intervention in women's groups for the identification, prevention and treatment of chronic suppurative otitis media in the children of Jumla, Nepal.
Scientific title
In women attending existing self-help groups in Jumla Nepal, does a participatory educational intervention improve their knowledge, attitude and practice regarding chronic suppurative otitis media in their children, compared to standard care (no intervention).
Secondary ID [1] 284162 0
Nil
Universal Trial Number (UTN)
U1111-1153-7954
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Suppurative Otitis Media 291260 0
Condition category
Condition code
Ear 291603 291603 0 0
Other ear disorders
Public Health 291617 291617 0 0
Health promotion/education
Infection 291618 291618 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A community-based, participatory, educational intervention in the existing women's self help groups in Jumla, Nepal over three consecutive group meetings. Women attend monthly one hour sessions over 3 months. Session 1 includes visual aids, role plays and discussion of causes, symptoms, prevention and treatment of ear infections. Session 2 is a practical session learning to mop ears and correctly insert drops. Session 3 is a recap with visual handout to take home.
Intervention code [1] 288862 0
Prevention
Intervention code [2] 288863 0
Behaviour
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 291548 0
% improvement in women's knowledge, attitude and practice questionnaire scores re chronic suppurative otitis media (Questionnaire prepared specifically for this study)
Timepoint [1] 291548 0
12 months
Secondary outcome [1] 307039 0
% reduction in prevalence of chronic suppurative otitis media in the children aged 0-12 years living in the household of the participant women, measured by clinical examination with digital otoscope images to be reviewed subsequently by ENT surgeon blind to allocation.
Timepoint [1] 307039 0
12 months
Secondary outcome [2] 307040 0
% reduction in prevalence of any abnormality tympanic membrane in the children aged 0-12 years living in the household of the participant women, measured by clinical examination with digital otoscope images to be reviewed subsequently by ENT surgeon blind to allocation.
Timepoint [2] 307040 0
12 months

Eligibility
Key inclusion criteria
Women attending existing women's self help groups in Jumla, Nepal who live in a household with at least one child aged 12 years and under
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women under the age of 18 years
Women who do not have a child aged 12 years and under in their household
Women who are unable to give informed consent
Men

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 56 women’s groups will be stratified into two strata according to the remoteness of their location and distance to the road. Although all of these groups are in a remote location, distance to the road determines accessibility of health and other services. Women in the groups are all poor so stratifying on socioeconomic status is unlikely to be necessary and would impede the effect of randomisation to control for confounding. Following stratification, a random sample of 30 clusters will be chosen for the study. Allocation will be done using a computer-generated random number sequence in Australia, by a member of the team not involved in data collection. The allocation will be communicated to the field team by internet or telephone. Baseline data will then be collected from all of the study groups. Following baseline data collection, the 30 study groups will be stratified by geography. Allocation into intervention or control group will then be conducted using a computer generated random number sequence by the same Australian based team member and communicated to the field team by telephone or internet. This means that baseline data collection cannot be biased by knowledge of allocation. After baseline data collection, equal numbers from each strata will be randomly allocated to the intervention group and to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be performed by a team member in Australia using computer generated random number sequence generator and communicated to the field team in Nepal by internet, or telephone if unavailable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A biostatistician will be consulted on several occasions during the study. Sample size was determined from data extracted from a previous study to find that for an unclustered study with a 5% two sided Type I error and 80% power to detect a 25% improvement in KAP score, sample size would be 114 women in each arm. Using previous intracluster coefficients, adjusting for stratification, sample size was determined at 223 women per arm. Adding an extra 2 clusters for stratification, would be 13 clusters per arm. Since data analysis is simpler and more robust with at least 15 clusters, sample size of 15 clusters per arm was chosen,which is total of approx 600 women.
Analysis will be by intention-to-treat, all study participants will be included in the analysis, even if lost to follow-up. All analysis will be adjusted for clustering. Covariates will be analysed, including SES, maternal and paternal education, caste, number of household members and examined in the analysis. Every effort will be made to have complete data but missing data will not be ignored in the analysis.
Data will be checked and cleaned before being entered into SPSS. Data will be analysed according to the CONSORT statement: extension to Cluster Randomised Trials. At baseline a comparison profile of both intervention and control groups will be provided. The primary and secondary outcomes - change in KAP score and prevalence of CSOM - will be compared between the two groups. Data will be analysed at both individual and cluster level. Cluster level analysis is very robust and, with 15 clusters in each arm, individual level analysis, adjusted for clustering ought also to be very robust. A summary measure, in this case the mean score of the KAP, will be calculated and then the intervention and control group compared for significance with a t-test at the cluster level. Individual level analysis will also be performed with regression, using mixed effects linear regression, which adjusts for the effect of clustering. Secondary outcomes will also be analysed at both individual and cluster level. Individual analysis will use logistic regression random effects model, which adjusts for clustering.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
20/06/2014
Date of last participant enrolment
Anticipated
15/05/2014
Actual
15/07/2014
Date of last data collection
Anticipated
Actual
10/08/2015
Sample size
Target
600
Accrual to date
Final
508
Recruitment outside Australia
Country [1] 5852 0
Nepal
State/province [1] 5852 0
Jumla

Funding & Sponsors
Funding source category [1] 288792 0
Self funded/Unfunded
Name [1] 288792 0
Country [1] 288792 0
Primary sponsor type
University
Name
University of New South Wales
Address
School of Public Health and Community Medicine
University of New South Wales
High St
Kensington 2052.
Country
Australia
Secondary sponsor category [1] 287488 0
None
Name [1] 287488 0
Address [1] 287488 0
Country [1] 287488 0
Other collaborator category [1] 277841 0
University
Name [1] 277841 0
Tribhuvan University
Institute of Medicine
Address [1] 277841 0
Maharajganj PO Box 1524
Kathmandu
Nepal
Country [1] 277841 0
Nepal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290633 0
University of New South Wales HREC
Ethics committee address [1] 290633 0
University of New South Wales
High St
Kensingon. NSW. 2052
Ethics committee country [1] 290633 0
Australia
Date submitted for ethics approval [1] 290633 0
25/11/2013
Approval date [1] 290633 0
27/02/2014
Ethics approval number [1] 290633 0
HREC Ref# HC13361
Ethics committee name [2] 290634 0
Nepal Health Research Council
Ethics committee address [2] 290634 0
Nepal Health Research Council
Ramshah Path
Kathmandu
Nepal
Ethics committee country [2] 290634 0
Nepal
Date submitted for ethics approval [2] 290634 0
25/03/2014
Approval date [2] 290634 0
09/06/2014
Ethics approval number [2] 290634 0
Reg no: 52/2014, Ref no: 1434

Summary
Brief summary
Chronic Suppurative Otitis Media (CSOM) is a common, preventable cause of deafness, chronic ill-health and, rarely, death in children in low resource countries. CSOM arises as a complication of untreated acute otitis media (AOM), which is almost universal in young children. Ear infections are so common, that they can seem normal and of low health priority (Monasta et al., 2012; World Health Organisation, 2004). Acute ear infections are simple and inexpensive to treat, which prevents CSOM, yet many children receive no assessment or intervention. CSOM is a disease of poverty and its social determinants. Low parental education level, low parental income, malnutrition, overcrowding, lack of clean water and sanitation are all associated with increased risk of CSOM. The children most at risk of CSOM are also the ones with least access to health education and health care.
The main aims of this research are to design and deliver an intervention, appropriate to the cultural context, to improve the knowledge, attitude and practice (KAP) of women regarding the ear health in children and to decrease the prevalence of Chronic Suppurative Otitis Media (CSOM) in children.
The research hypothesis is that the intervention will increase the KAP of the women and reduce the prevalence of CSOM in the children.
Trial website
Nil
Trial related presentations / publications
Clarke, S., Richmond, R., Worth, H. & Wagle, R. (2015). A study protocol for a cluster randomised trial for the prevention of chronic suppurative otitis media in children in Jumla, Nepal. BMC Ear nose and throat disorders 15 (4).DOI 10.1186/s12901-015-0017-x
Clarke, S., Richmond, R., Worth, H. & Hayen, A. (2016, June). A cluster randomised trial for the prevention of chronic suppurative otitis media. Recent advances in otitis media, Meeting of the International Society for Otitis Media, Gold Coast.
Public notes

Contacts
Principal investigator
Name 46542 0
Prof Robyn Richmond
Address 46542 0
School of Public Health and Community Medicine
University of New South Wales
High St
Kensington. NSW. 2052
Country 46542 0
Australia
Phone 46542 0
(612) 9385 2512
Fax 46542 0
Email 46542 0
R.Richmond@unsw.edu.au
Contact person for public queries
Name 46543 0
Dr Susan Clarke
Address 46543 0
School of Public Health and Community Medicine
University of New South Wales
High St
Kensington 2052
Country 46543 0
Australia
Phone 46543 0
+61408644872
Fax 46543 0
Email 46543 0
susan.clarke@unswalumni.com
Contact person for scientific queries
Name 46544 0
Dr Susan Clarke
Address 46544 0
School of Public Health and Community Medicine
University of New South Wales
High St
Kensington 2052
Country 46544 0
Australia
Phone 46544 0
+61 408644872
Fax 46544 0
Email 46544 0
susan.clarke@unswalumni.com

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
SourceTitleYear of PublicationDOI
EmbaseA study protocol for a cluster randomised trial for the prevention of chronic suppurative otitis media in children in Jumla, Nepal.2015https://dx.doi.org/10.1186/s12901-015-0017-x
EmbaseEffect of a participatory intervention in women's self-help groups for the prevention of chronic suppurative otitis media in their children in Jumla Nepal: A cluster-randomised trial.2019https://dx.doi.org/10.1186/s12887-019-1539-y
N.B. These documents automatically identified may not have been verified by the study sponsor.