- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02623166
Treatment of Pneumonia, Diarrhoea and Fever in Children by Community Health Workers
September 5, 2018 updated by: Society for Applied Studies
To Operationalise the Policy of Treating Uncomplicated Pneumonia, Diarrhoea and Fever in Children Aged 2-59 Months by Community Health Workers(CHW)
The investigators propose to test the feasibility and acceptability of community health workers (ASHAs and ANMs) being able to treat sick children in the community.
There is a national policy for treatment for children aged 2-59 months with illnesses such as pneumonia, diarrhea and fever by community health workers (CHWs), this policy has not been implemented as yet in Haryana.
This research will identify barriers and opportunities for use of CHWs as treatment sources.
Study Overview
Status
Completed
Conditions
Detailed Description
Using indepth interviews, focus group discussions and other qualitative research methods barriers and opportunities for promoting use of ASHAs as a treatment source for diarrhea, pneumonia and fever will be identified.
An intervention package which includes training of ASHAs and ANMs to treat uncomplicated cases of pneumonia, diarrhea and fever, ensuring they have required supplies, creating awareness in community and monitoring and supervising the treatment provided by them will be implemented in primary health centre areas in Haryana, India.
ASHAs will treat cases of fast breathing pneumonia with amoxicillin and refer children with danger signs or chest indrawing pneumonia.
Three rounds of cross sectional surveys will be conducted to ascertain prevalence of morbidity, careseeking and hospitalizations in children aged 2 to 59 months.
Study Type
Observational
Enrollment (Actual)
24000
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
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Haryana
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Palwal, Haryana, India, 121102
- CHRD, Society for Applied Studies
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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
2 months to 4 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study will be conducted in 2 primary health centres.
These include 6 sub centres in Rasoolpur PHC (population ~57000) and 7 sub centres in Mandkola PHC (population ~57000).
Description
Inclusion Criteria:
- Children aged 2-59 months with uncomplicated pneumonia or diarrhoea or fever
Exclusion Criteria:
- Refusal for participation
- Diarrhea with dehydration
- Danger signs
- Chest indrawing pneumonia
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in the proportion of caregivers seeking care for 2-59 months old children with pneumonia, diarrhoea and fever from trained Community Health Workers (CHW)
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Increase in the proportion of caregivers seeking care for 2-59 months old children with pneumonia, diarrhoea and fever from trained Community Health Workers (CHW)
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Increase in the proportion of caregivers seeking care for 2-59 months old children with pneumonia, diarrhoea and fever from trained Community Health Workers (CHW)
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care.
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care.
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care.
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Perceptions and experiences of caregivers belonging to disadvantaged section of the community who could not access treatment from CHWs assessed by using questionnaires, indepth interviews
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Perceptions and experiences of caregivers belonging to disadvantaged section of the community who could not access treatment from CHWs assessed by using questionnaires, indepth interviews
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Perceptions and experiences of caregivers belonging to disadvantaged section of the community who could not access treatment from CHWs assessed by using questionnaires, indepth interviews
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Proportion of caregivers who complied with referral.
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Proportion of caregivers who complied with referral.
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Proportion of caregivers who complied with referral.
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Proportion of children treated by ANMs with injectable antibiotics.
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Proportion of children treated by ANMs with injectable antibiotics.
Time Frame: To be assessed 5 months after start of study
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To be assessed 5 months after start of study
|
Proportion of children treated by ANMs with injectable antibiotics.
Time Frame: To be assessed 8 months after start of study
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To be assessed 8 months after start of study
|
Proportion of times of families who tried to contact CHW and were unable to do so.
Time Frame: To be assessed at baseline
|
To be assessed at baseline
|
Proportion of times of families who tried to contact CHW and were unable to do so.
Time Frame: To be assessed 5 months after start of study
|
To be assessed 5 months after start of study
|
Proportion of times of families who tried to contact CHW and were unable to do so.
Time Frame: To be assessed 8 months after start of study
|
To be assessed 8 months after start of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarmila Mazumder, MBBS, PhD, Centre for Health Research and Development, Society for Applied Studies
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
November 1, 2015
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
November 24, 2015
First Submitted That Met QC Criteria
December 4, 2015
First Posted (Estimate)
December 7, 2015
Study Record Updates
Last Update Posted (Actual)
September 6, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/517094-0
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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