Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2018-028361 on 6 November 2019. Downloaded from mHealth tool to improve community health agent performance for child development: study protocol for a cluster- randomised controlled trial in Peru Christopher Michael Westgard ,1,2 Natalia Rivadeneyra,2 Patricia Mechael3 To cite: Westgard CM, ABSTRACT Strengths and limitations of this study Rivadeneyra N, Mechael P. Introduction Cultivating child health and development mHealth tool to improve creates long- term impact on the well- being of the ► The intermediate variables will be assessed to mea- community health agent individual and society. The Amazon of Peru has high levels performance for child sure the behaviour changes that occurs along the of many risk factors that are associated with poor child development: study protocol for theory of change. The study will be able to evaluate development. The use of ‘community health agents’ (CHAs) a cluster- randomised controlled the various mediator variables that are expected to has been shown to be a potential solution to improve child trial in Peru. BMJ Open contribute to the final objective. 2019;9:e028361. doi:10.1136/ development outcomes. Additionally, mobile information and ► A process evaluation with qualitative assessments communication technology (ICT) can potentially increase bmjopen-2018-028361 will be used to identify issues of implementation and the performance and impact of CHAs. However, there is Prepublication history for inform the implementation plan for scalability. ► a knowledge gap in how mobile ICT can be deployed to this paper is available online. ► The mHealth tool and the monitoring and evaluation improve child development in low resource settings. To view these files, please visit strategy provides a surveillance mechanism that will Methods and analysis The current study will evaluate the the journal online (http:// dx. doi. allow for continuous feedback on the use of the in- implementation and impact of a tablet-based application org/ 10. 1136/ bmjopen- 2018- tervention tool and health status of the study group. 028361). that intends to improve the performance of CHAs, thus ► Child development will be assessed through a parent improving the child-rearing practices of caregivers and reported survey which provides the potential for the Received 05 December 2018 ultimately child health and development indicators. parent to give inaccurate responses due to a social Revised 25 September 2019 The CHAs will use the app during their home visits to http://bmjopen.bmj.com/ desirability bias. However, the instrument that was Accepted 26 September 2019 record child health indicators and present information, chosen for the assessment, the Caregiver- Reported images and videos to teach key health messages. The Early Development Instrument, has shown to have impact will be evaluated through an experimental cluster a high correlation to results obtained from surveys randomised controlled trial. The clusters will be assigned that administer direct observation of the child. to the intervention or control group based on a covariate- ► The secondary outcomes that measure changes of constrained randomisation method. The impact on child the CHAs will be underpowered due to limitations in development scores, anaemia and chronic malnutrition will the sample size of CHAs. be assessed with an analysis of covariance. The secondary outcomes include knowledge of healthy child-rearing on September 25, 2021 by guest. Protected copyright. practices by caregivers, performance of CHAs and use of health services. The process evaluation will report on 5 never reach their cognitive, linguistic and 1 2 © Author(s) (or their implementation outcomes. The study will be implemented socioemotional potential. Chronic malnu- employer(s)) 2019. Re- use in the Amazon region of Peru with children under 4. The trition, anaemia and iodine deficiency delay permitted under CC BY-NC. No commercial re- use. See rights results of the study will provide evidence on the potential the physical and cognitive development of and permissions. Published by of a mHealth tool to improve child health and development children, reduce their level of energy and BMJ. indicators in the region. weaken their immune system. Child devel- 1Department of Maternal and Ethics and dissemination The study received approval opment can also be delayed by low levels of from National Hospital ‘San Bartolome’ Institutional Child Health, University of North early childhood stimulation.1 3 In the Peru- Carolina at Chapel Hill Gillings Ethics Committee on 8 November 2018 (IRB Approval vian Amazon, there is a high prevalence of School of Global Public Health, #15463–18) and will be disseminated via peer-reviewed Chapel Hill, North Carolina, USA publications. various risk factors associated with develop- 2 Elementos, Lima, Peru Trial registration number ISRCTN43591826. mental delay, especially in rural areas. A study 3HealthEnabled, Cape Town, conducted in 2017 showed that the preva- South Africa lence of developmental delay in the Amazon BACKGROUND of Peru was 26.7%.4 In the Amazonian depart- Correspondence to In low- income and middle- low income coun- ment of Loreto, the prevalence of childhood Christopher Michael Westgard; tries, millions of children under the age of cmwestgard@ unc. edu anaemia is 49.9% and chronic malnutrition is Westgard CM, et al. BMJ Open 2019;9:e028361. doi:10.1136/bmjopen-2018-028361 1 Open access BMJ Open: first published as 10.1136/bmjopen-2018-028361 on 6 November 2019. Downloaded from 23.6% (2017).5 Those indicators are worse in indigenous HYPOTHESIS communities.6–9 The study hypothesises that an mHealth tool with educa- The well- being of children in communities can be tional content developed for the local context will improve greatly increased by improving families’ understanding the capacity of the CHAs to transmit health messages to of healthy child- rearing practices. Health- promotion the caretakers, thus creating behaviour change that will strategies that establish an intercultural dialogue with lead to better health and child development outcomes families can do a better job at promoting healthy prac- for the children. The hypothesis is based on a theory of 10 11 tices than promotion through the health centres. A change that tracks the mediating variables and considers programme can train and support community members the potential outputs and outcomes generated by the to conduct health promotion that can create behaviour intervention.42 The theory of change displayed in figure 1 changes and improve child development outcomes. highlights the various components that are included in Community health agents (CHAs) can play an essential the tablet- based application and unfolds the expected role in reducing inequalities in health services by acting outcomes of each. The theory of change is presented as a link between communities and the local health as a comparison to the status- quo; traditional CHA 11–13 services. The CHA can establish a warm relation- programme in Peru that use paper- based reporting and ship with the caregiver, thus increasing the acceptance educational material. of health advice, improving the absorption of knowledge Based on the theory of change, the study has the and getting caregivers involved in the identification and 14–21 following hypotheses: resolution of their own health problems. The posi- H1: The mHealth tool will improve the perfor- tive impact of CHAs has been associated with a reduction mance of CHAs during their home visits with chil- in malnutrition, anaemia, malaria, cases of diarrhoea, dren, as measured by doses, content and interpersonal improved child development and other health indica- 11 22 23 relationships. tors. Therefore, understanding and improving the H2: Improved performance by CHAs will increase performance of CHAs can greatly improve behavioural knowledge acquisition and healthy child-rearing prac- outcomes of caregivers, increase the utilisation of local tices by caregivers. health services and enhance the overall health and well- H3: Improved knowledge and healthy practices by care- being of communities.14 24–31 givers will improve the health and development of the Several studies have shown that mobile information children that receive the intervention. and communication technology (ICT) can improve the performance of CHAs in their ability to perform health promotion, collect and report timely information regarding family health, provide health services such as OBJECTIVES vaccines and refer families to appropriate local health http://bmjopen.bmj.com/ 32–39 Main aim services. Additionally, when a mobile ICT tool is The objective of the study is to evaluate the impact of the used by a CHA, the device can increase the confidence mHealth tool (tablet with application) on child develop- the caregivers have in the messages being transmitted ment and nutrition status of children aged 6 to 36 months and increase the confidence the CHAs have in their own compared with children who receive home visits from work.32 33 37 38 40 41 Through implementation science, inno- CHA without the mHealth tool. vations in mobile ICTs and strategies for child health and development can be extended to low resource settings to Primary outcomes empower local actors and spread the benefits of advance- on September 25, 2021 by guest. Protected copyright. ments in technology.35 36 1. (Primary Objective) Improve child development scores A study on the performance