Impact of Training on Diarrhoea Management
Primary Purpose
Acute Childhood Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Training intervention
Sponsored by
About this trial
This is an interventional health services research trial for Acute Childhood Diarrhea focused on measuring NGO zinc scale, compliance with WHO zinc treatment recommendations
Eligibility Criteria
Inclusion Criteria:
- Care takers of the children aged 6 months to 5 years with a prevalent case of diarrhea at the time of the household surveys (within the past 2 weeks). Within each site a systematic household survey will be completed for the identification of any child 6 months to 5 years who has a prevalent case of at least 2 days duration.
Health Care Providers
- NGO licensed "sub-assistant community medical officers (SACMOs)
- Private sector, unlicensed providers: village practitioners and traditional healers
Exclusion Criteria:
N/A
Sites / Locations
- International Centre for Diarrhoeal Disease Research, Bangladesh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training Intervention
Control
Arm Description
One service provider group received training
Control group service providers did not received intervention training
Outcomes
Primary Outcome Measures
To document changes in zinc coverage for acute childhood diarrhoea
Secondary Outcome Measures
To document changes in inappropriate use of antibiotics and antidiarrheals
Full Information
NCT ID
NCT02143921
First Posted
May 18, 2014
Last Updated
May 20, 2014
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT02143921
Brief Title
Impact of Training on Diarrhoea Management
Official Title
Impact of an NGO Training and Support Intervention on Private Sector Provider Diarrhea Management Practices
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Alternative, sustainable interventions in support of zinc treatment for childhood diarrhea need to be identified. Within the NGO sector, direct provision of health services is provided, however some NGOs also work closely with the private sector providers. Hypothetically, this avoids unnecessary duplication of effort and enhances the quality of the care provided in the private sector. This study will provide objective evidence of the impact of this approach, using the scale-up of zinc for the treatment of childhood diarrhoea as a test case. The study will be assessing NGO impact among unregulated (unlicensed), rural service providers. Further, this study will serve to assess the value of this model of scaling up activities in the non-state sector with a particular eye toward more generalizable and replicable improvement in quality of care strategies between NGOs and unlicensed private providers. This will be controlled before-after (CBA) study. An equivalent control area will be included in the study. The objective is to document changes in zinc and antibiotic as well as anti-diarrhoeal usage in childhood diarrhea following a scale-up intervention package delivered by a local NGO to local private providers. This will include sensitization, training and follow-up support. Impact will be assessed in terms of changes in zinc coverage and antibiotic use among households in the catchment population served by these providers. The study will be conducted in four unions located in Sreepur Upazila within Gazipur district, located north to Dhaka. Two of the unions, namely Rajabari and Prohladpur comprising 55 villages with 15,530 households and an estimated 76,150 population will serve as intervention area. The other two unions Telihat and Barmi will be taken as control sites. They contain 53 villages with 19,898 households and an estimated 99,000 population. The curative health services in these sites are provided by local drug vendors, village practitioners, traditional healers, and licensed government, private or NGO health service providers. Data will be collected through survey and in-depth interviews. Data will be entered and analyzed using SPSS version 12.0. Absolute counts, proportions, and means with 95% confidence interval will be calculated. These and regression analysis will be done using STATA version 9, cluster survey program, that accounts for potential within cluster homogeneity. Based upon the household surveys, the outcomes that will be calculated are: coverage-the proportion receiving zinc, ORS (zinc and ORS), and antibiotics or antidiarrhoeals and changes in coverage 6 months following the introduction of the intervention package, equity: who is receiving zinc by age, gender and socioeconomic status. For differences in categorical outcomes crude relative risks and 95% confidence intervals will be determined. It is expected that the study will help in increasing zinc coverage for the treatment of children under five years of age and decrease in the use of antibiotics and antidiarrhoeals within the NGO catchment population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Childhood Diarrhea
Keywords
NGO zinc scale, compliance with WHO zinc treatment recommendations
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
1160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training Intervention
Arm Type
Experimental
Arm Description
One service provider group received training
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group service providers did not received intervention training
Intervention Type
Behavioral
Intervention Name(s)
Training intervention
Intervention Description
Intervention group service providers received intervention training
Primary Outcome Measure Information:
Title
To document changes in zinc coverage for acute childhood diarrhoea
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To document changes in inappropriate use of antibiotics and antidiarrheals
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
To identify barriers/disincentives to the prescribing of zinc treatment among private providers
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Care takers of the children aged 6 months to 5 years with a prevalent case of diarrhea at the time of the household surveys (within the past 2 weeks). Within each site a systematic household survey will be completed for the identification of any child 6 months to 5 years who has a prevalent case of at least 2 days duration.
Health Care Providers
NGO licensed "sub-assistant community medical officers (SACMOs)
Private sector, unlicensed providers: village practitioners and traditional healers
Exclusion Criteria:
N/A
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
12. IPD Sharing Statement
Citations:
PubMed Identifier
25398082
Citation
Rahman AS, Islam MR, Koehlmoos TP, Raihan MJ, Hasan MM, Ahmed T, Larson CP. Impact of NGO training and support intervention on diarrhoea management practices in a rural community of Bangladesh: an uncontrolled, single-arm trial. PLoS One. 2014 Nov 14;9(11):e112308. doi: 10.1371/journal.pone.0112308. eCollection 2014.
Results Reference
derived
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Impact of Training on Diarrhoea Management
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