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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176914
• Other study ID #: MRCZ/A/2099
• Status: Completed
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: University of Zimbabwe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Women of child bearing age who do not dwell permanently in the study area

2. Women who are very ill and mentally challenged

Related Conditions & MeSH terms

• Diarrhea
• Fever
• Malnutrition
• Pneumonia

Intervention

Behavioral:
• prevention and management of childhood illnesses at community level
provision of critical health education and targeted promotion services to the participants in their locality
• conventional community interventions
community health programs as the sole source of health education

Locations

Country	Name	City	State
Zimbabwe	College of Health Sciences	Harare

Sponsors (2)

Lead Sponsor	Collaborator
University of Zimbabwe	NORHED

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in child morbidity	Incidence of childhood illnesses	9- 12 months
Secondary	Early ANC uptake	Number of women who booked in the first trimester	3 Months
Secondary	Institutional deliveries	Proportion of women with children 0-48 months who delivered at a health facility	3 months
Secondary	Postnatal care uptake	Proportion of women with a child 0 -48 months who received post-natal care in their last delivery	3 months
Secondary	Knowledge levels on child care	Proportion of women with a child 0-48 months who have basic knowledge on dangers signs and management of childhood illnesses	3 months