Condition category
Not Applicable
Date applied
03/05/2020
Date assigned
19/05/2020
Last edited
18/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Most of the essential health services are not one-time services but required regular follow-ups. These follow-ups have been a major issue affecting the coverages of some health services in the Lagos State, Nigeria.
The Primary Health Care Board (PHCB) under the auspices of Lagos State Ministry of Health collaborated with Japan International Cooperation Agency (JICA) developed an SMS reminder system to the clients who are required to return health facility and to complete a full course of service/regimen.
The purpose of this study is to assess the effectiveness of short text reminder messages (SMSs) to clients through mobile technology in their continuous return for ANC, FP and child immunization including routine Vitamin A supplementation.

Who can participate?
All clients who have appointments at the 33 PHCs in Lagos state for antenatal care (ANC), family planning, and child immunization including routine Vitamin A supplementation during the study period.

What does the study involve?
All clients who visited the 33 PHCs for antenatal care (ANC), family planning, and child immunization including routine Vitamin A supplementation are registered for the study with verbal consent. They are randomly allocated to intervention and control groups. The intervention group receives a short text reminder message two days before their appointment while the control group do not receive an SMS reminder message. If clients in the intervention group do not return to the health facility, they receive another reminder message seven days after the appointment day. As part of the standard of care, nurses will inform the clients in both intervention and control groups of the next appointment dates.

What are the possible benefits and risks of participating?
The benefit of participating in this study is receiving the SMS reminder on their appointments only. There is no risk of participating in this study since as part of the standard of care, nurses informed the clients in both intervention and control groups of the next appointment dates at the service provision

Where is the study run from?
Lagos State (Nigeria)

When is the study starting and how long is it expected to run for?
October 2018 to November 2019

Who is funding the study?
Japan International Cooperation Agency

Who is the main contact?
Dr Hirotsugu Aiga, hirotsugu.aiga@nagasaki-u.ac.jp
Mr Yoshito Kawakatsu, yoshitok@uw.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hirotsugu Aiga

ORCID ID

Contact details

1-12-4
Sakamoto
Nagasaki
852-8523
Japan
+81-95-819-7949
hirotsugu.aiga@nagasaki-u.ac.jp

Type

Scientific

Additional contact

Mr Yoshito Kawakatsu

ORCID ID

http://orcid.org/0000-0003-1853-533X

Contact details

1959 NE Pacific Street
Seattle
WA
98195
United States of America
+1-206-221-4970
yoshitok@uw.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

LSMH/4168/VII

Study information

Scientific title

Effectiveness of SMS appointment reminder and defaulter tracking system in Lagos State, Nigeria: A randomized controlled trial

Acronym

Study hypothesis

SMS reminder would improve health facility attendance by reminding the appointments of vaccines, antenatal care, and family planning

Ethics approval

Approved 13/12/2016, Health Research and Ethics Committee at Lagos State University Teaching hospital (1-5, OBA AKINJOBI ROAD, IKEJA, LAGOS, P.M.B. 21005, NIgeria; +234 - 1 - 471-0670; dcst@lasuth.org), ref: LREC /06/10/766

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Attendance at appointments at local health centre for vaccination, ANC, and family planning

Intervention

A client in the intervention group received a short text reminder message two days before the scheduled appointment day (appointment reminder) while a client with an appointment under the control group (service as usual) did not receive an SMS reminder message. Clients in the intervention group who did not show up for their appointments received another reminder message seven days after the appointment day (patient-tracking message). As part of the standard of care, nurses informed the clients in both intervention and control groups of the next appointment dates.

The duration of the intervention was 6 months, with 4 months of follow up.

Randomization of participants was performed daily for all appointments two days hence, with groups matched in terms of the dates that the appointments were created.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The return status of the appointments for the three health services (i.e. ANC, FP, and child immunization including routine Vitamin A supplementation) measured for the duration of the study using patient records. If a client returns to a health facility for her appointment, they were categorized as returned cases, while if do not return, they were categorized as a defaulter

Secondary outcome measures

Timing of receiving vaccination, ANC and FP measured for the duration of the study using patient records

Overall trial start date

01/10/2018

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All clients who visited the 33 PHCs in Lagos state for antenatal care (ANC), family planning, and child immunization including routine Vitamin A supplementation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Since we planned to conduct a stratified analysis for each service, the target sample size for ANC, FP and child immunization were 2,492, 580, and 7,630 respectively. Assumptions used for the sample size calculation were power at 0.9, an alpha error at .05, and the increased return rate from 70% to 75% in ANC, from 70% to 80% in FP and from 80% to 82.5% in immunization.

Participant exclusion criteria

1. Clients with the appointments of other services (e.g., HIV/TB care)
2. Clients without a mobile phone or accessible phone number

Recruitment start date

14/01/2019

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Nigeria

Trial participating centre

Adeniyi Jones PHC
Lagos
N/A
Nigeria

Trial participating centre

Ajeabo PHC
Lagos
N/A
Nigeria

Trial participating centre

Ajibulu / Mafoluku PHC
Lagos
N/A
Nigeria

Trial participating centre

Akinwunmi Ambode PHC
Lagos
N/A
Nigeria

Trial participating centre

Akowonjo PHC
Lagos
N/A
Nigeria

Trial participating centre

Alapere PHC
Lagos
N/A
Nigeria

Trial participating centre

Alausa PHC
Lagos
N/A
Nigeria

Trial participating centre

Ashogbon PHC
Lagos
N/A
Nigeria

Trial participating centre

Ayantuga PHC
Lagos
N/A
Nigeria

Trial participating centre

Ejire Phc 
Lagos
N/A
Nigeria

Trial participating centre

Festac PHC
Lagos
N/A
Nigeria

Trial participating centre

Ifako Ijaye PHC
Lagos
N/A
Nigeria

Trial participating centre

Ijora Oloye PHC
Lagos
N/A
Nigeria

Trial participating centre

Ikate PHC
Lagos
N/A
Nigeria

Trial participating centre

Ikosi PHC
Lagos
N/A
Nigeria

Trial participating centre

Ilasa PHC
Lagos
N/A
Nigeria

Trial participating centre

Ipaja PHC
Lagos
N/A
Nigeria

Trial participating centre

Ipinlerere PHC
Lagos
N/A
Nigeria

Trial participating centre

Iwaya PHC
Lagos
N/A
Nigeria

Trial participating centre

IYANA EJIGBO PHC
Lagos
N/A
Nigeria

Trial participating centre

Ketu (Mascara) PHC
Lagos
N/A
Nigeria

Trial participating centre

Layeni PHC
Lagos
N/A
Nigeria

Trial participating centre

Ogudu PHC
Lagos
N/A
Nigeria

Trial participating centre

Ojodu PHC
Lagos
N/A
Nigeria

Trial participating centre

Ojokoro PHC
Lagos
N/A
Nigeria

Trial participating centre

Ondo St West PHC
Lagos
N/A
Nigeria

Trial participating centre

Orisunbare PHC
Lagos
N/A
Nigeria

Trial participating centre

Palm Avenue PHC
Lagos
N/A
Nigeria

Trial participating centre

Rauf Aregbesola PHC
Lagos
N/A
Nigeria

Trial participating centre

Simpson PHC
Lagos
N/A
Nigeria

Trial participating centre

Sura PHC
Lagos
N/A
Nigeria

Trial participating centre

Ogba PHC
Lagos
N/A
Nigeria

Trial participating centre

Ohekenu PHC
Lagos
N/A
Nigeria

Sponsor information

Organisation

Japan International Cooperation Agency

Sponsor details

1F–6F Ninbancho Building Center
Chiyoda
Tokyo
102-0084
Japan
+81 (0)3-5226-6660
mptpr@jica.go.jp

Sponsor type

Government

Website

http://www.jica.go.jp/english/

Funders

Funder type

Government

Funder name

Japan International Cooperation Agency

Alternative name(s)

Agence Japonaise de Coopération Internationale, Agencia de Cooperación Internacional del Japón, JICA

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Japan

Results and Publications

Publication and dissemination plan

We will publish this research in an international journal with close collaboration with PHCB.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the ownership of the data. The dataset used in this study belongs to the Lagos State Ministry of Health. Without permission from the Ministry, we cannot share raw data with anybody.

Intention to publish date

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/05/2020: Trial’s existence confirmed by Lagos State Government.