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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02623166
Other study ID # 2015/517094-0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date February 2017

Study information

Verified date September 2018
Source Society for Applied Studies
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24000
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 59 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
India CHRD, Society for Applied Studies Palwal Haryana

Sponsors (2)

Lead Sponsor Collaborator
Society for Applied Studies World Health Organization

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) To be assessed at baseline
Primary 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) To be assessed 5 months after start of study
Primary 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) To be assessed 8 months after start of study
Primary Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care. To be assessed at baseline
Primary Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care. To be assessed 5 months after start of study
Primary Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care. To be assessed 8 months after start of study
Secondary Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions To be assessed at baseline
Secondary Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions To be assessed 5 months after start of study
Secondary Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions To be assessed 8 months after start of study
Secondary Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires To be assessed at baseline
Secondary Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires To be assessed 5 months after start of study
Secondary Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires To be assessed 8 months after start of study
Secondary 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 To be assessed at baseline
Secondary 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 To be assessed 5 months after start of study
Secondary 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 To be assessed 8 months after start of study
Secondary Proportion of caregivers who complied with referral. To be assessed at baseline
Secondary Proportion of caregivers who complied with referral. To be assessed 5 months after start of study
Secondary Proportion of caregivers who complied with referral. To be assessed 8 months after start of study
Secondary Proportion of children treated by ANMs with injectable antibiotics. To be assessed at baseline
Secondary Proportion of children treated by ANMs with injectable antibiotics. To be assessed 5 months after start of study
Secondary Proportion of children treated by ANMs with injectable antibiotics. To be assessed 8 months after start of study
Secondary Proportion of times of families who tried to contact CHW and were unable to do so. To be assessed at baseline
Secondary Proportion of times of families who tried to contact CHW and were unable to do so. To be assessed 5 months after start of study
Secondary Proportion of times of families who tried to contact CHW and were unable to do so. To be assessed 8 months after start of study