Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001149651
Ethics application status
Approved
Date submitted
10/10/2014
Date registered
30/10/2014
Date last updated
30/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A medication education program for children with asthma - a feasibility study.
Scientific title
In children with asthma, does a comprehensive asthma education program provided to them and their carers, as compared to usual care, improve caregiver quality of life.
Secondary ID [1] 285394 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma in children 293131 0
Condition category
Condition code
Respiratory 293466 293466 0 0
Asthma
Public Health 293577 293577 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The education will consist of a PowerPoint program with graphically designed and culturally relevant content synchronized with key activities for the child. It will be delivered by one of the asthma educators (researchers). In the intervention group, after completing the research record, the education session (the SSP) was conducted. The core asthma education content will cover information about asthma, asthma triggers, different asthma medications and their use, self-management and first-aid skills. This content was embedded within an audio visual dialogue using Power Point. The child was involved simultaneously by providing them with a child friendly workbook which matched the audio-visual education of the parents. The educational session will take an hour usually (ranging from 1 hour to 1 hour 30 minutes). Handouts of the audio-visual education will be provided to the parents/caregivers of children with asthma. Following the education, children will set a few key goals to achieve for their asthma, and the child-carer pair will be referred onsite to a physician for the usual consultation appointment and an asthma action plan, which is usually 15- 20 minutes. The template suggested by National Asthma Council Australia was used. A section is also developed in the patient asthma record to investigate whether the child had an action plan, if they had it, then they were further queried about who wrote the plan and how confident the parent and the child were in using it. The adherence and barriers to adherence will be mapped by using modified sections of a previously validated brief medication questionnaire (BMQ).
The Follow up plan: A face to face appointment will be conducted at 1 and 6 months after baseline for the intervention group. The intervention group will also receive a reminder telephone call 3 months after baseline where goal setting progress and any changes in medication or general asthma management were reviewed. The 1 month and 6 month follow-up will include re-measuring all the outcome measures collected at baseline. At these visits the physician was not involved. At 6 months, the parent-child pair will be asked to complete a customized 'satisfaction' questionnaire in addition to re-completing the other questionnaires completed at baseline
Intervention code [1] 290360 0
Treatment: Other
Comparator / control treatment
In the control group, parents and children will be given a standard information pack and requested to obtain an action plan as they move on to see their doctor for a 'usual appointment'. Standard information included information about asthma symptoms, triggers, medications, adherence, medication related beliefs, inhaler technique, using a written asthma action plan, setting health goals.
Control group
Active

Outcomes
Primary outcome [1] 293321 0
Paediatric Asthma Caregiver Quality of Life
The Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ), a previously validated questionnaire available in Hindi was used. Responses were given on 7-point scales where the score range was between 1 (severe impairment for each item life) and 7 (no impairment to quality of life).
Timepoint [1] 293321 0
Baseline, 1 and 6 months
Secondary outcome [1] 310794 0
Asthma Control measured using the Asthma Control Questionnaire (child),




Written asthma action plan possession
Timepoint [1] 310794 0
Baseline and 6 months
Secondary outcome [2] 310939 0
Asthma Knowledge (parent) using non validated customised asthma knowledge questionnaire developed by researchers.
Timepoint [2] 310939 0
Baseline, 1 month and 6 months
Secondary outcome [3] 310940 0
Medication Adherence (child), measured using the Brief Medication Questionnaire
Timepoint [3] 310940 0
Baseline, 1 month and 6 months
Secondary outcome [4] 310941 0
Inhaler Technique (child), measured using Manufacturer based usage checklists
Timepoint [4] 310941 0
Baseline, 1 months and 6 months
Secondary outcome [5] 310942 0
Goals Setting
Self report to questions - using multiple choice responses ( goals achieved/goals not achieved/ patient working towards goals)
Timepoint [5] 310942 0
Baseline, 1 month and 6 months

Eligibility
Key inclusion criteria
(a) the child with asthma needs to be between 7-12 years of age, (b) the family (parents) speak either English/Hindi. (c) the child has a diagnosis of asthma and (d) has had at least two asthma-related visits to the hospital in the prior 12 months.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children having other chronic diseases along with asthma. Any condition which would make it difficult for child to return for appointments, follow advice e.g. cancers, intellectual disability.

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)
“Allocation is not concealed”
We did not use allocation concealment although physicians were blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The parent child pair was allocated to either the intervention group or usual care group using a random number sequence generated using the RAND function in Excel.
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
The SPSS version 20.0 (SPSS, IL, USA) will be used for data analysis. Test for normality will be performed using the one sample, Kolmogorov-Smirnov test. For between groups comparisons, if the data are normally distributed Student’s t-test for independent samples or 1 way ANOVA (e.g. to compare more than 2 groups) will be used. For non-normal data Fisher Exact test or Mann Whitney U test will be used. For within group comparisons, if the data are normally distributed repeated measures t tests for paired samples or Wilcoxon Signed Ranks Test will be used. The level of significance was set at 0.05 for all statistical tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2012
Actual
22/06/2012
Date of last participant enrolment
Anticipated
30/09/2012
Actual
31/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6399 0
India
State/province [1] 6399 0
New Delhi

Funding & Sponsors
Funding source category [1] 290068 0
University
Name [1] 290068 0
University of Sydney research maintenance allowance and supervisor personal research funds.
Country [1] 290068 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Bandana Saini, rm S114, Building A15, Faculty of Pharmacy, Science Road, Camperdown Campus, University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 288758 0
None
Name [1] 288758 0
Address [1] 288758 0
Country [1] 288758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291772 0
University of Sydney
Ethics committee address [1] 291772 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 291772 0
Australia
Date submitted for ethics approval [1] 291772 0
Approval date [1] 291772 0
25/05/2012
Ethics approval number [1] 291772 0
14801

Summary
Brief summary
Asthma is possibly one of the most common non-infectious respiratory diseases among Indian children. Although asthma cannot be cured, appropriate management can control the condition effectively. Medication is pivotal in asthma control. Appropriate use of medications in children is associated with an array of factors – such as parental beliefs, fears and socioeconomic circumstances, characteristics of the child, the medication regimen and device selected, and the prescribing physician. Whilst many educational interventions have been effectively implemented for improving paediatric asthma control and adherence, only a few studies focus on medication or have education directed simultaneously on the parent and the child. There is thus an urgent need to design educational programs for children, focusing on medication use in asthma, which have clear objectives and meet the local needs. This educational intervention will enhance the understanding of children with asthma and their parents/carer, empower them with self management skills and hence improve the quality of their use of asthma medications.
Trial website
Trial related presentations / publications
Grover C, Goel N, Armour C, van Asperen PP, Moles R, Gaur SN, Saini B. Medication Education Program For Indian Children With Asthma- A Feasibility Study. (under review)
Public notes

Contacts
Principal investigator
Name 51662 0
Dr Bandana Saini
Address 51662 0
Rm S114, Building A15, Faculty of Pharmacy, Science Road, Camperdown Campus, University of Sydney, NSW 2006
Country 51662 0
Australia
Phone 51662 0
61293516789
Fax 51662 0
Email 51662 0
bandana.saini@sydney.edu.au
Contact person for public queries
Name 51663 0
Dr Charu Grover
Address 51663 0
B-1/53 Janak Puri, New Delhi-110058
C/O Dr Bandana Saini Rm S114, Building A15, Faculty of Pharmacy, Science Road, Camperdown Campus, University of Sydney, NSW 2006
Country 51663 0
India
Phone 51663 0
919811482540
Fax 51663 0
Email 51663 0
cgro9516@uni.sydney.edu.au
Contact person for scientific queries
Name 51664 0
Dr charu grover
Address 51664 0
B-1/53 janak puri, New Delhi- 110058
C/O Dr Bandana Saini Rm S114, Building A15, Faculty of Pharmacy, Science Road, Camperdown Campus, University of Sydney, NSW 2006
Country 51664 0
India
Phone 51664 0
919811482540
Fax 51664 0
Email 51664 0
cgro9516@uni.sydney.edu.au

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