Condition category
Pregnancy and Childbirth
Date applied
17/07/2015
Date assigned
23/07/2015
Last edited
06/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background
Since January 2010, the Institute of International Programs (IIP) and the National Statistical Office of Malawi (NSO) have collaborated on the Real-time Mortality Monitoring (RMM) project. One component of RMM evaluates the accuracy and reliability of deaths in children under 5 (under-five mortality) collected by Health Surveillance Assistants (HSAs), government employed community health workers, in the Salima and Balaka districts. Pregnancy tracking and birth and death documentation are activities already within the scope of work of HSAs, so RMM is a project that strengthens the current system. In an assessment run in December 2011, we found that that HSAs under-reported under-five mortality. The mHealth data quality intervention was designed and implemented to improve completeness of pregnancy tracking. Our primary objective is to improve the pregnancy outcome documentation by treatment groups. A complete pregnancy is a pregnancy that results in a live birth, abortion, miscarriage or stillbirth, or the pregnant woman moving out of the area (out-migration).

Who can participate?
HSAs assigned to each of the 160 randomly selected catchment areas participated in the study.

What does the study involve?
The intervention was implemented in two phases. Phase one ran for seven months between December 2012 and June 2013. Phase two ran for five months from July 2013 through November 2013. The HSAs were randomly assigned to either the treatment or control group. Those in the treatment group received high-intensity SMS with motivational and data quality content based on project data quality guidelines. For phase one, the treatment group received SMS three times a week. During phase two, the treatment group received SMS five times a week. The control group received minimal-intensity SMS with basic motivational content twice a week during the 12 month intervention period.

What are the possible benefits and risks?
The participants should benefit from the SMS support by improving the tracking and documentation of pregnancies and pregnancy outcomes. There are no expected risks.

Where is the study run from?
The study is run from the National Statistical Office in Malawi, the in-country collaborator.

When is the study starting and how long is it expected to run for?
January 2010 to March 2014

Who is the main contact?
Olga Joos
ojoos1@jhu.edu

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Olga Joos

ORCID ID

Contact details

Department of International Health
Johns Hopkins Bloomberg School of Public Health
Baltimore
21205
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of a mHealth data quality intervention to improve documentation of pregnancy outcomes by Health Surveillance Assistants in Malawi: a cluster randomized trial

Acronym

Study hypothesis

We hypothesize that Health Surveillance Assistants (HSA) receiving high-intensity, data quality short message service (SMS, or text messages) will improve complete pregnancy documentation by 25% as compared to control group HSA receiving minimal-intensity motivational SMS.

Ethics approval

1. National Health Sciences Research Committee, 13/02/2009, ref: Protocol #617
2. Institutional Review Board at the Johns Hopkins University Bloomberg School of Public Health, 30/07/2009, ref: IRB #2247

Study design

Cluster randomised trial with an interventional design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

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

Condition

We are evaluating completeness of pregnancy documentation. We define a complete pregnancy as a pregnancy with a matched outcome: live birth, transfer-out of the pregnant mother, abortion, miscarriage, or stillbirth.

Intervention

We implemented the intervention in two phases. Phase one ran for seven months between December 2012 and June 2013. Phase two ran for five months from July 2013 through November 2013. Throughout both phases, the treatment group received high-intensity SMS with motivational content and data quality content based on project guidelines. For phase one, the treatment group received SMS three times a week. During phase two held from July 2013-November 2013, the treatment group received SMS five times a week. The control group received minimal-intensity SMS with basic motivational content twice a week during the 12 month intervention period.

The intervention was randomized and designed at the cluster level, health facilities, but the SMS were received directly by HSA assigned to the health facilities. We constrained the cluster randomization of 30 health facilities using three variables to improve balance between treatment arms. Once we completed the randomization and assigned 15 health facilities to the control group and 15 health facilities to the treatment group, we verified that the spread of clusters was evenly distributed between the two study districts.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

An improvement in matched pregnancies during the intervention period in the treatment group compared to the control group. A matched pregnancy is defined as a pregnancy with a matched outcome: live birth, out-migration of the mother, abortion, stillbirth, or miscarriage.

Secondary outcome measures

An improvement in matched pregnancies between baseline and intervention periods by group. Matched pregnancies will be evaluated for the control group and treatment group separately.

Overall trial start date

01/01/2009

Overall trial end date

30/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

160 HSAs, one for each of the 160 randomized catchment areas selected for the RMM study

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

Not fulfilling inclusion criteria

Recruitment start date

01/01/2010

Recruitment end date

30/10/2013

Locations

Countries of recruitment

Malawi

Trial participating centre

Institute for International Program
Department of International Health Johns Hopkins Bloomberg School of Public Health 615 N. Wolfe Street, E8547
Baltimore
21205
United States of America

Trial participating centre

National Statistical Office
Zomba
PO Box 333
Malawi

Sponsor information

Organisation

Foreign Affairs, Trade and Development Canada

Sponsor details

125 Sussex Drive
Ottowa
K1A 0G2
Canada

Sponsor type

Government

Website

http://www.international.gc.ca/international/index.aspx?lang=eng

Funders

Funder type

Government

Funder name

Foreign Affairs, Trade and Development Canada

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We tested the Real-time Mortality Monitoring approach in various African countries and plan to publish results and lessons learned in a collection of manuscripts. One manuscript will present results from the mHealth data quality intervention conducted within the RMM Malawi study. We plan to present changes in the completeness of pregnancy documentation, defined as a pregnancy matched to an outcome. We will compare matched pregnancy results between treatment groups during the intervention period and among treatment groups comparing pre-and post-intervention periods.

Intention to publish date

31/12/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26731401

Publication citations

Additional files

Editorial Notes