Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303802849181 Date of Approval: 29/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Utilization of Mobile Technology in Improving the Completeness and Timeliness of Routine Childhood Immunization Among Parents in Kano Metropolis
Official scientific title Utilization of Mobile Technology in Improving the Completeness and Timeliness of Routine Childhood Immunization Among Parents in Kano Metropolis
Brief summary describing the background and objectives of the trial Background: Vaccine preventable diseases remains the commonest cause of childhood mortality worldwide. A major reason responsible for this is that many children do not get immunized with age-appropriate vaccines. The potentials shown by mobile phone in improving health interventions can be leveraged upon to improve the timeliness of routine childhood immunization. Purpose: This study will be conducted to examine the effect of utilization of mobile technology in improving the completeness and timeliness of routine childhood immunization among parents in Kano Metropolis. Methods: A clustered randomized controlled trial will be conducted with mothers who recently gave birth, have access to mobile phone, willing to receive mobile phone reminder (text messages/calls). A total of 554 mothers/participants will be randomly selected from 4 high volume primary health care facilities within Kano Metropolis. The selected participants will then be allocated randomly to intervention and control groups. Mobile phone reminders (Short Message Service SMS) will be sent to participants in the intervention group, three days prior and on the date which participants children are due to receive all routine vaccines. Immunization status of children of participants in the intervention and control groups will be tracked continuously for all vaccines until 3 months after the last SMS reminder is sent. All statistical data will be analyzed using descriptive and inferential statistics using the Statistical Package for Social Sciences (SPSS) version 27.0. Findings from the study will be presented in line with Consolidated Standards of Reporting Trials CONSORT and Template for Intervention Description and Replication (TIDieR) checklist. The aim of the study is to examine the effect of utilization of mobile technology in improving the completeness and timeliness or routine childhood immunization among parents. The specific objectives of the study are; 1. To assess the effect of SMS reminder
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Vaccine preventable diseases
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/02/2023
Actual trial start date 20/03/2023
Anticipated date of last follow up 10/10/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 554
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Mobile phone reminder Six months tracking and follow-up Mothers in control group will not receive any intervention 277 Uncontrolled
Experimental Group Reminding parents on the immunization of their children 2 reminders (text message and a follow-up call) will be sent to parents for all dose of vaccine scheduled for the 6th, 10th and 14th week of birth Actual intervention will last for 4 months but study will be conducted within 1 year Mobile phone reminders (SMS and follow-up calls) will be sent to participants in the intervention group three days prior and on the date which participants children are due to receive routine vaccines from birth to 14th week. The vaccines to be included in the study are Pentavalent vaccines, Oral Polio Vaccine and Pneumococcal Conjugate Vaccine which are administered at 6th, 10th and 14th week of birth. Immunization status of children of both participants in the intervention and control groups will be tracked continuously for all studied vaccines until 3 months after the last reminder is sent. 277
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. women who gave birth not more than three weeks 2. Women who have access to mobile phone (own or have access) 3. Women who can read text messages or have access to someone who can read and explain to them 4. women willing to receive text message and phone call reminders 1. women who plan to immunize their children in health facilities other than the one in which they were recruited 2. Women who will migrate out of the study area Adult: 19 Year-44 Year 15 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/02/2023 Research Ethics Committee Kano State Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Post office road Kano 700213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1. Motivate mothers on the immunization of their children with or without reminder. 2. Reduced childhood mortality and morbidity from vaccine preventable diseases. 1 to 2 years intervention
Primary Outcome 2.Improved completeness of childhood immunization by parents. 2. Improved timeliness of routine childhood immunization from 1 to 6 months after commencement of intervention starting.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bayero University Kano Nigeria Gwarzo road Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano TETFund Institutional Based Research Grant Gwarzo Road Kano 700213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano TETFund Institutional Based Research Grant Gwarzo Road Kano 700213 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Umar Yunusa uyunusa.nur@buk.edu.ng +2348038199802 NO 6B Port Louis
City Postal code Country Position/Affiliation
Kano 700213 Nigeria Lecturer Department of Nursing Science Bayero University Kano
Role Name Email Phone Street address
Public Enquiries Abdulrashid Idris aidris.nur@buk.edu.ng +2348063375818 Salare
City Postal code Country Position/Affiliation
Kano 700213 Nigeria Lecturer Department of Nursing Sciences Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries Umar Lawal ulbello.nur@buk.edu.ng +2348036628115 Al Umma close
City Postal code Country Position/Affiliation
Kano 700213 Nigeria Lecturer Department of Nursing Science Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries). All individual data collected during trial will be shared after de-identification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date Data will be made indefinitely by the Journal that published the trial and on demand via uyunusa.nur@buk.edu.ng
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information