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临床试验/NCT03176914
NCT03176914已完成不适用

Testing the Effectiveness of a Modified Care Group Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe

University of Zimbabwe2 个研究点 分布在 1 个国家目标入组 765 人开始时间: 2017年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
765
试验地点
2
主要终点
Reduction in child morbidity

研究概览

简要总结

This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by comparing the effect of the intervention to that of the conventional community interventions.

详细描述

In Zimbabwe the Neonatal and infant mortality rate are 31/1000 and 57/1000 respectively (ZDHS, 2011). Seventy -four percent of these death occur at community level due to the delay in deciding to seek care . The government of Zimbabwe has intensified facility based health systems though very little has been done in community health system strengthening yet there is glaring evidence from recent studies that the burden of infant and child morbidity and mortality is largely at community level. The effect of social mobilization approaches in reducing socio-cultural causes of morbidity and mortality is not known. Evidence base for participatory models and their effectiveness remains scanty and in-country, there is no approved , integrated community mobilization model that achieves saturation coverage in addressing all facets of community maternal newborn and child health along the continuum of care. Community immersion with health services is in line with the Alma Ata Declaration of the Primary Health Care approach that seeks to decentralize health services to the marginalized people. The study will test the effectiveness of the contextualized model in improving child health outcomes.

A cluster randomized controlled design will be used in 2 randomly selected districts of Mashonaland East , Zimbabwe. Women 18- 49 years with children 0-48 months in the selected districts will be recruited and followed up for 9-12 months . Stratified randomization will be used to select 11 pairs of participating villages . Central randomization will be employed for allocation concealment . The sample size was calculated in STATA 13. assuming a morbidity prevalence of 50% with a margin error of 5%. The assumed intra-cluster correlation coefficient (ICC) of 0.05 with a level of significance of 5% , design effect of 2.45 and power of 0.9. The sample size per arm will be 330 mother-child pairs and each arm will have 11 clusters.

Data will be collected monthly using monthly data collection tools. The study will require participants to commit at most 2 hours once in every two weeks. The main intervention is provision of critical health education and targeted promotion services to the participants in their locality. Participatory approaches will be employed in the intervention arm for learning and sharing of good community IMNCI practices for the prevention and management of childhood illnesses. Participants will be motivated through learning exchange visits and provision of promotional materials as incentives for successful completion and practice of recommended behaviors and child care practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The data analysts will be provided with coded data that doesn't reflect which arm the data is from.

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant and lactating women staying in the study area with children below 4 years

排除标准

  • Women of child bearing age who do not dwell permanently in the study area
  • Women who are very ill and mentally challenged

研究组 & 干预措施

Intervention arm

Experimental

Eleven clusters (Villages) will be randomly selected. A cluster will comprises of 10-15 volunteers selected from a cohort 10-15 households. Educative sessions will be held in each cluster once every fortnight using a participatory methods by a trained Village Health Worker (VHW). A session will focus on one thematic area running for 1-2 hours. Trained volunteers will in turn replicate the session(s) in their cohorts and do home visits to monitor care practices and screen children for various ailment. Health information is collated from each cluster and consolidated by the VHW who reports monthly at the clinic.

干预措施: prevention and management of childhood illnesses at community level (Behavioral)

Conventional Intervention arm

Active Comparator

In the conventional mobilization system, a Village Health Worker facilitates community health programs as the sole source of health education for the entire villages. She does home visits, child growth monitoring and the various components primary health care at village level inclusive of disease surveillance and community case management using the 'supermarket approach' , whereby 3 or more themes are covered in a space of 10- 30 minutes in functions like funerals, village gatherings and other opportune moments. The Village Health worker prepares village monthly reports on all the indicators on community health and submits to the local health centre.

干预措施: conventional community interventions (Behavioral)

结局指标

主要结局

Reduction in child morbidity

时间窗: 9- 12 months

Incidence of childhood illnesses

次要结局

  • Early ANC uptake(3 Months)
  • Institutional deliveries(3 months)
  • Postnatal care uptake(3 months)
  • Knowledge levels on child care(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maxwell Mhlanga

Principal Investigator

University of Zimbabwe

研究点 (2)

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