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

Primary Purpose

Pneumonia, Diarrhea, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
prevention and management of childhood illnesses at community level
conventional community interventions
Sponsored by
University of Zimbabwe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Community mobilisation

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • College of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Conventional Intervention arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction in child morbidity
Incidence of childhood illnesses

Secondary Outcome Measures

Early ANC uptake
Number of women who booked in the first trimester
Institutional deliveries
Proportion of women with children 0-48 months who delivered at a health facility
Postnatal care uptake
Proportion of women with a child 0 -48 months who received post-natal care in their last delivery
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

Full Information

First Posted
May 24, 2017
Last Updated
March 29, 2019
Sponsor
University of Zimbabwe
Collaborators
NORHED
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1. Study Identification

Unique Protocol Identification Number
NCT03176914
Brief Title
Testing the Effectiveness of a Modified Community Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe
Official Title
Testing the Effectiveness of a Modified Care Group Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zimbabwe
Collaborators
NORHED

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Diarrhea, Malnutrition, Fever
Keywords
Community mobilisation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will have an intervention arm under which the study intervention will be implemented and this will be compared with the outcomes in the conventional intervention arm. Each arm will have 11 clusters of an average size of 50.
Masking
Outcomes Assessor
Masking Description
The data analysts will be provided with coded data that doesn't reflect which arm the data is from.
Allocation
Randomized
Enrollment
765 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Intervention arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
prevention and management of childhood illnesses at community level
Intervention Description
provision of critical health education and targeted promotion services to the participants in their locality
Intervention Type
Behavioral
Intervention Name(s)
conventional community interventions
Intervention Description
community health programs as the sole source of health education
Primary Outcome Measure Information:
Title
Reduction in child morbidity
Description
Incidence of childhood illnesses
Time Frame
9- 12 months
Secondary Outcome Measure Information:
Title
Early ANC uptake
Description
Number of women who booked in the first trimester
Time Frame
3 Months
Title
Institutional deliveries
Description
Proportion of women with children 0-48 months who delivered at a health facility
Time Frame
3 months
Title
Postnatal care uptake
Description
Proportion of women with a child 0 -48 months who received post-natal care in their last delivery
Time Frame
3 months
Title
Knowledge levels on child care
Description
Proportion of women with a child 0-48 months who have basic knowledge on dangers signs and management of childhood illnesses
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant and lactating women staying in the study area with children below 4 years Exclusion Criteria: Women of child bearing age who do not dwell permanently in the study area Women who are very ill and mentally challenged
Facility Information:
Facility Name
College of Health Sciences
City
Harare
ZIP/Postal Code
00263
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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