- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02143921
Impact of Training on Diarrhoea Management
May 20, 2014 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh
Impact of an NGO Training and Support Intervention on Private Sector Provider Diarrhea Management Practices
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dhaka, Bangladesh, 1212
- International Centre for Diarrhoeal Disease Research, Bangladesh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training Intervention
One service provider group received training
|
Intervention group service providers received intervention training
|
No Intervention: Control
Control group service providers did not received intervention training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To document changes in zinc coverage for acute childhood diarrhoea
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To document changes in inappropriate use of antibiotics and antidiarrheals
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify barriers/disincentives to the prescribing of zinc treatment among private providers
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
May 18, 2014
First Submitted That Met QC Criteria
May 20, 2014
First Posted (Estimate)
May 21, 2014
Study Record Updates
Last Update Posted (Estimate)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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