mHealth field study among community health workers in the Balaka and Salima districts of Malawi
| ISRCTN | ISRCTN24785657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24785657 |
| Protocol serial number | N/A |
| Sponsor | Foreign Affairs, Trade and Development Canada |
| Funder | Foreign Affairs, Trade and Development Canada |
- Submission date
- 17/07/2015
- Registration date
- 23/07/2015
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Department of International Health
Johns Hopkins Bloomberg School of Public Health
Baltimore
21205
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized trial with an interventional design |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/03/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 160 |
| Key inclusion criteria | 160 HSAs, one for each of the 160 randomized catchment areas selected for the RMM study |
| Key exclusion criteria | Not fulfilling inclusion criteria |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 30/10/2013 |
Locations
Countries of recruitment
- Malawi
- United States of America
Study participating centres
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street, E8547
Baltimore
21205
United States of America
PO Box 333
Malawi
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/01/2016 | Yes | No | |
| Dataset | 16/03/2023 | 18/08/2023 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/08/2023: Dataset added.
