Home » Trials » SLCTR/2019/027


A non-randomized controlled before and after study to determine the effectiveness of an Illustrated Information Leaflet (IIL) on maternal practice of administering paediatric antibacterial suspensions

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SLCTR Registration Number

SLCTR/2019/027


Date of Registration

07 Aug 2019

The date of last modification

Aug 24, 2019



Application Summary


Scientific Title of Trial

A non-randomized controlled before and after study to determine the effectiveness of an Illustrated Information Leaflet (IIL) on maternal practice of administering paediatric antibacterial suspensions


Public Title of Trial

A non randomized controlled trial to determine the effectiveness of an illustrated information leaflet on teacher mothers’ practices on administering paediatric antibacterial suspensions


Disease or Health Condition(s) Studied

Administration of antibacterial suspension


Scientific Acronym

None


Public Acronym

None


Brief title

An intervention to improve the administering practices of antibacterial suspension by mothers


Universal Trial Number

U1111-1234-2595


Any other number(s) assigned to the trial and issuing authority

EC-18-006 ,ERC ,Faculty of Medicine ,UOC


Trial Details


What is the research question being addressed?

Can an illustrated information leaflet reduce the errors made by teacher mothers when administering paediatric antibacterial suspensions?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Single blinded : Investigators


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Other


Study Phase

Not Applicable


Intervention(s) planned

An initial descriptive study was done on teacher mothers to determine the prevalence of proper and improper practice when administering paediatric antibacteric suspensions using a scorecard. For the intervention study participants from different education zones in the Jaffna district will be selected. A block randomization procedure will be done to have the proportion of correct practice: incorrect practice teachers across the two arms. The final illustrated information leaflet (IIL) was translated into Tamil and was pretested This IIL conveys information on reconstitution techniques, measuring devices, and administration and storing instructions. The leaflet will be given by principal investigator just before collecting the data. Time will be given to read and understand the leaflet. Any queries will be clarified before collecting data


Inclusion criteria

1.Female teachers below 60 years 2. Have at least one child under the age of 6


Exclusion criteria

  1. Teacher whose family members are health care professionals (doctor/nurse /pharmacist)
  2. Whose children have long term illness and visit the hospital at least once a week 3.Who have previous work experience as a health care professional or social worker 4.Who has participated in any study related to oral liquid dosage forms administration previously


Primary outcome(s)

1.

1.Proportion of mothers with administration errors when administering oral antibacterial suspension. This will be assessed using a scorecard which was developed by the experts during the descriptive study. There are 21 steps each carrying either 1 or 0 marks

[

Soon after the intervention and 3 months after the intervention

]

Secondary outcome(s)

1.

1.Acceptability of the intervention by the participants using a questionnaire.

8 questions will be marked by the mothers on a Liket scale of 1-5 If all the questions get overall panel median score of > 3 it is considered as acceptable.

[

After 3 months of the intervention

]

Target number/sample size

20 in each arm


Countries of recruitment

Sri Lanka


Anticipated start date

2019-08-08


Anticipated end date

2019-11-08


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

self funded


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-02-15


Approval number

EC-18-006


Details of Ethics Review Committee

Name: Ethics Review committee,Faculty of Medicine,University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800, Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Abarna Nadeshkumar
Lecturer
Department of Pharmacy and Pharmaceutical Sciences Faculty of Allied Health Sciences University of Sri Jayewardenepura Nugegoda

+94777568799

abi0108@yahoo.com

Contact Person for Public Queries

Professor Shalini Sri Ranganathan
Head
Department of Pharmacology Faculty of Medicine University of Colombo
+94 (0) 112695300 ext 198


sshalini14@hotmail.com


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results