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.: PACTR201905787868050 Date of Approval: 06/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Exploring the use of mobile phone technology for optimizing, tracking and responding to children's developmental progress in Korogocho, Nairobi, Kenya
Official scientific title Exploring the use of mobile phone technology for optimizing, tracking and responding to children's developmental progress in Korogocho, Nairobi, Kenya
Brief summary describing the background and objectives of the trial Abstract/Summary Background: The massive use of technology can be leveraged to facilitate access to growth and development programs for children with access constraints. Existing programs supporting children’s growth and development especially for children younger than three years are inadequate and not accessible to most families. In most cases, primary caregivers are unable to identify delayed milestones in their children’s growth and development due to inadequate information on how to assess the key developmental milestones, and they often report the cases when they have become very severe. To promote early identification of possible developmental delays, the African Population and Health Research Center (APHRC) together with Val Partners will develop, implement and evaluate the use of mobile phone technology to help young mothers track their children's development. Objective: The objective of the proposed study will be to develop and test the feasibility of using mobile phone technology for optimizing, tracking, and responding to children's developmental progress. Study design: The study will employ a quasi-experimental design and will use a mixed-methods approach combining quantitative and qualitative methodologies. This will be a two-arm study, where the first arm will be trained on the use of a mobile phone application to assess their children’s growth and development, while the second group will receive the standard of care provided by community health volunteers (CHVs). A total of 220 mothers/primary caregivers-child dyads will be recruited into this study. We will estimate the causal effect of the intervention using mixed linear models and the Difference-in-Differences estimator. Study duration: 24 months
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 28/03/2019
Actual trial start date
Anticipated date of last follow up 23/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Child stimulation messages through SMS 1 year The specific intervention will be developed through the following steps: i. Co-designing the mobile application with the caregivers and CHVs: In the first few months of the project, the project team will co-develop and co-design the mobile application with caregivers and other stakeholders involved in the project that will enable parents to track and respond to developmental progression of their children. Appropriate child stimulation messages will first be created together with caregivers, through focus group discussions to establish the type of messages to be delivered to caregivers based on their current caregiving practices, and social and cultural contexts. This information will be used to develop, with other partners, a health-messaging platform for use with mothers/caregivers; ii. Training of the CHVs and the caregivers: CHVs and caregivers will be trained on how to use the designed mobile application to record achievement of milestones and track children’s growth and development. A six-day residential training will be conducted; iii. Caregivers will receive weekly stimulation messages on play and communication activities to engage in to enhance their children’s development. The mobile phone technology innovation will be capable of generating customized child stimulation messages based on the age of the child and previous feedback; iv. Home visits: The home visits will be conducted weekly over a period of approximately 12 months. CHVs will visit the homes regularly to establish if the child stimulation messages received by caregivers are being put into practice; v. Referrals and connections to other services for families in the areas of health and nutrition: When the child's development is delayed, this will be flagged on the mobile app system and a message will be sent to the assigned CHV for action. The CHV will then visit that particular household so that s/he can provide the necessary support to the caregiver/parent to address the delay. 110
Control Group Government standard services 1 year Government standard services 110 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All primary caregivers of children aged between six and 24 months will be eligible for inclusion in the study. Families will be selected on the basis of their vulnerability status (for example, teenage mothers, poor health and nutrition indicators, HIV exposure, and poverty levels). They will be long-term residents (more than one year) of the study area. Any short-term residents (less than one year) will be excluded from the study. Children above three years will also be excluded from the study. Also excluded will be women (or men) incapable of giving consent (e.g. those with mental illness). Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 24 Month(s) Both
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 18/02/2019 AMREF ESRC
Ethics Committee Address
Street address City Postal code Country
30125 Nairobi Kenya Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Children developmental outcome After 1 year of the intervention
Primary Outcome Strengthens CHVs’ capacity to support, manage and sustain early identification of developmental delays and stimulation of children in their communities; After 1 year of the intervention
Primary Outcome Improve mothers /caregivers’ ECD knowledge, attitude, and practices 1 year
Primary Outcome Improved primary caregivers’ well-being (mental health and stress levels), sense of parenting efficacy and connections to services 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
African Population Health and Research Center 2nd Floor Manga Close, Off Kirawa Road, Nairobi Kenya Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenge Canada 661 University Avenue, MaRS Centre, West Tower, Suite 1720, Toronto, ON M5G 1M1, Canada Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor APHRC Manga Close, Off Kirawa Road Nairobi 00100 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Val Partners Nairobi Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patricia Wekulo pwekulo@aphrc.org 722205933 Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Associate Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Silas Onyango sonyango@aphrc.org 722205933 Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 0100 Kenya Research Officer
Role Name Email Phone Street address
Public Enquiries Okelo Kenneth kokelo@aphrc.org 722205933 Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 0100 Kenya Research Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Analyzed summary of recruited participants Study Protocol 1 year Controlled, through email
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