MHealth tool to improve community health agent performance for child development: Study protocol for a cluster-randomised controlled trial in Peru

Introduction Cultivating child health and development creates long-term impact on the well-being of the individual and society. The Amazon of Peru has high levels of many risk factors that are associated with poor child development. The use of ‘community health agents’ (CHAs) has been shown to be a potential solution to improve child development outcomes. Additionally, mobile information and communication technology (ICT) can potentially increase the performance and impact of CHAs. However, there is a knowledge gap in how mobile ICT can be deployed to improve child development in low resource settings. Methods and analysis The current study will evaluate the implementation and impact of a tablet-based application that intends to improve the performance of CHAs, thus improving the child-rearing practices of caregivers and ultimately child health and development indicators. The CHAs will use the app during their home visits to record child health indicators and present information, images and videos to teach key health messages. The impact will be evaluated through an experimental cluster randomised controlled trial. The clusters will be assigned to the intervention or control group based on a covariate-constrained randomisation method. The impact on child development scores, anaemia and chronic malnutrition will be assessed with an analysis of covariance. The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services. The process evaluation will report on implementation outcomes. The study will be implemented in the Amazon region of Peru with children under 4. The results of the study will provide evidence on the potential of a mHealth tool to improve child health and development indicators in the region. Ethics and dissemination The study received approval from National Hospital ‘San Bartolome’ Institutional Ethics Committee on 8 November 2018 (IRB Approval #15463-18) and will be disseminated via peer-reviewed publications. Trial registration number ISRCTN43591826.

The impact will be evaluated through an experimental cluster randomised controlled trial. Each cluster represents a CHA because the children that receive visits from the same CHA must receive the same intervention. Each cluster will be matched with a second cluster using covariate-constrained randomisation.43 Recruitment and baseline surveys will be conducted before allocation to the intervention or control group for each cluster. The variables that will be used to covariate-constrained randomisation include: the size of the community, type of health facility in the community, distance to the nearest health centre (level I-2) and prevalence of anaemia. For each cluster pair, one cluster will be randomly assigned to the intervention group and the other to the control group. The covariate-constrained randomisation will be conducted with an open-sourced algorithm and the program, R.44 The study will be implemented in the Amazon region of Peru. The study will be carried out in the department of Loreto, province of Maynas, and districts of Mazan, Punchana and Indiana. The district of Mazan has a population of 13 779,45 a prevalence of chronic malnutrition of 24.4% and a prevalence of anaemia at 39.1%, in 2017.46 The capital of the district of Mazan is located approximately 1-1/2 hours by boat from the capitol city of the province, Iquitos. The district of Punchana has a population of 91 128,45 a prevalence of chronic malnutrition of 22.7% and a prevalence of anaemia of 39.9%.46 The capital of Punchana, is 20 min from the city of Iquitos. The district of Indiana has a population of 11 301,45 a prevalence of chronic malnutrition of 22.4% and a prevalence of anaemia at 46.7%, in 2017.46 The capital of the district of Indiana is 1.5 hours by boat from the city of Iquitos. The research team, with the support of the Regional Ministry of Health of Loreto, will choose the communities that will be included in the study after travelling to the communities to ensure they meet the selection criteria. The study communities must have the following characteristics: The communities must have an active CHA programme for the study because we are measuring the impact of included the mHealth tool in existing CHA programme. The community cannot be participating in another study that includes an intervention that was/will be implemented due to the confounding variables that would created in our study and the other study. The communities must be less than 6 hours from Iquitos due to budgetary restraints that hinder the research team’s ability to consistently travel six or more hours to execute the study. The size limitation of the community is required to ensure the study obtains the minimum number of children to power the study with the limited number of tablets. The study population includes: All children between 0 and 36 months in the communities will receive visits from a CHA, in the intervention and control groups. However, only the CHAs in the intervention group will receive a tablet with the application to assist their home visits. All the children in the intervention group will have the opportunity to receive the intervention with the tablet. To assess the impact of the intervention, a sample of the population will be chosen at random to receive the evaluation. The inclusion criteria for the study sample are the following: The minimum age of the child to be included in the impact evaluation is determined by the quality of the early childhood development tool. Assessment of child development is more accurate with children older than 5 months.47 The maximum age of the children for the study is determined by the CHA programme which limits home visits by CHAs to children up to 36 months old. The minimum age of the caregiver is 16 because that is the age determined by the communities and the local ethics committee to be capable of giving an informed consent. It is important to capture information from mothers below 18 years of age because 39% of the mothers in the region have their first child before the age of 17.4 Caregivers who do not want to receive visits from CHAs will be excluded because they will not receive the intervention, nor be included in the control group. The exclusion criteria for the study sample are: Families that do not speak Spanish cannot be included because the study does not have appropriate translators for indigenous languages. Children with disabilities will be excluded in the evaluation because the child development evaluation tool is not equipped to evaluate children with these conditions. However, children with disabilities will still receive the intervention. The sample size for the evaluation is calculated to measure the effect size on the primary outcome indicator, child development. A study in the Amazon region of Peru (2017) determined that the SD of communication scores, determined by the Ages and Stages Questionnaire, was 15.19.4 The current study predicts a 20% increase in child development scores which will result in an effect size of 0.49 (average communication score was 37.48, a 20% increase is 44.98, 0.49 SD) (data available in public repository).4 To calculate the minimal sample size needed, the following parameters were determined: The following calculation is used to determine the sample size: The sample size per group (t-test) with no clusters would be 88. To control for the ICC, the per group sample size (88) is multiplied by the VIF (VIF=1+(average cluster size–1)*ICC=2.2) to determine the minimal sample size to be 193 per group.48 The study will include 21 clusters, and nine children and caregivers per cluster. To measure the impact of the intervention and understand the perspective of the users, a series of instruments will be applied to the study participants. The instruments include evaluation of child development, attitudes and practices questionnaire, knowledge evaluation, performance evaluation of CHAs, and collection of anaemia and anthropometric indicators. Qualitative surveys will also be used to evaluate the satisfaction of CHAs and caregivers in relation to the intervention. The questionnaires and evaluations will be carried out in the homes of the participants. The researcher will ask if a caregiver of a child within the age range is in the home, if so, they will explain the study and ask the caregiver if they want to participant and are willing to sign the informed consent. The researcher will record the responses of the questionnaires and evaluation on a smart phone or electronic tablet. Child development can be effectively evaluated with an instrument that utilises caregiver-reported data to assess the ability of the child to perform age-relevant developmental activities.47 49–52 The current study will use the Caregiver-Reported Early Development Instrument (CREDI) to evaluate child development.53 54 The CREDI has been validated as an effective instrument to evaluate child development, including low-resource settings in 17 countries.54 The CREDI is effective for large-scale, population-wide studies because it requires less time, materials and evaluator expertise than other similar instruments.53 The CREDI is conducted by asking the caregiver if the child is currently capable of completing a list of age-appropriate activities, in which the caregiver can respond by indicating; yes, no or I don’t know. The CREDI will provide a developmental score and a classification that represents the child’s development trajectory. These classifications will be used as the primary dependent variables of the study. The study will use a quantitative questionnaire to measure the attitudes and practices of caregivers that influence maternal and child health. The following topics are included in the questionnaire: demographic information, safe pregnancy practices, feeding practices, prevention of illnesses, early childhood stimulation and use of local health services. The questionnaire will be conducted with all caregivers of the children included in the study. The questionnaire will take approximately 10 min. To assess the knowledge of healthy child-rearing practices by the caregiver, an instrument was created based on the literature.13 55–57 The knowledge evaluation asks the caregiver questions regarding maternal and child health, nutrition, sanitation and infectious diseases. The questions are open-ended to give the caregiver the opportunity to provide multiple answers that display their knowledge of the topic. The knowledge evaluation will take place directly after the Attitudes and Practices Questionnaire. The knowledge evaluation will be scored by giving the participant one point for every correct answer they provide. The correct answers will be added together to provide a total ‘Knowledge Score’ for the caregiver. The performance evaluation of CHAs was based on an instrument built by the University of West Indies and the Inter-American Development Bank to measure the quality of home visits by CHAs.14 The performance evaluation includes questions related to the use of materials, activities, promotion of child development, relationship between CHA and caregivers, and relationships between the CHA and the child. The performance evaluation was modified and validated during a previous study in the Amazon region within the local CHA programme. The instrument provides further focus on health messages provided by the CHA and the needs of the communities in the Amazon.29 To conduct the performance evaluation, the researcher will accompany the CHA on their home visit with a child to observe the home visit. The researcher will observe the home visit in silence, trying not to influence the dynamic of the visit. The researcher will take notes during the visit and complete the performance evaluation immediately after the conclusion of the home visit. The research team will survey the local health centres in the communities to obtain statistics regarding the use of health services related to maternal and child health, including child growth monitoring check-ups, prenatal check-ups, immunisation coverage, distribution of micronutrient supplements, distribution of antiparasitic medicine and distribution of oral rehydration salts for diarrhoea. The survey will be conducted with the nurse that conducts maternal and child health evaluations at the health centre. The survey will take approximately 15 min and can be filled out independently by the health post representative. The Child Health Education and Surveillance Tool (CHEST) application will be used to collect child health indicators by CHAs during their home visits. The children have a card with information that was recorded during their growth monitoring check-ups at the local health centre, including height, weight, age, vaccines and haemoglobin levels (when tested). The CHA will observe the information written on the card and record it with the application. The CHA will also ask additional questions regarding the health of the child, including incidences of diarrhoea, cough, fever, malaria and other illness. The data from the application will be uploaded to the secured server when the CHA or supervisor has access to the cellular network. The Questionnaire on Satisfaction and Self-Efficacy of CHAs will be used to measure the degree of satisfaction and self-efficacy the CHAs have from using the CHEST application during their home visits. The questions are both quantitative and qualitative. The CHAs will have the opportunity to describe how the experience with the tablet could be improved. The Questionnaire on Satisfaction of Caregivers will be used to measure the degree of satisfaction of the caregivers that received the intervention. The questions are both quantitative and qualitative. The caregivers will have the opportunity to describe what they like and don’t like about the use of a tablet during the home visits. The study was created through formative research done in the same communities to identify their needs and desires related to improving child health and development. A performance evaluation study was conducted with the CHAs in the region by the author.29 In the study, the CHAs and caregivers expressed their need and desire for more information regarding topics of health and child development. The current intervention was created to address those needs. The results of the study will be presented to the participants, including the CHAs, caregivers, health facility personal and Regional Ministry of Health in the form of a study brief that indicates the results of each indicator collected. The results will be presented to the public via publication of results in an international scientific journal. Patients were not involved in the design or recruitment of the study.

• westgard, christopher michael
• rivadeneyra, natalia
• mechael, patricia