Clinical trial NCT02623166: Treatment of Pneumonia, Diarrhoea and Fever in Children by Community Health Workers
Official title: To Operationalise the Policy of Treating Uncomplicated Pneumonia, Diarrhoea and Fever in Children Aged 2-59 Months by Community Health Workers(CHW)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Diarrhea, Fever
Keywords: Pneumonia
Fever
Diarrhoea
Lead sponsor: Society for Applied Studies
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2015-12-07
Enrollment: 24000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: To be assessed at baseline
measure: 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)
timeFrame: To be assessed 5 months after start of study
measure: 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)
timeFrame: To be assessed 8 months after start of study
measure: Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care.
timeFrame: To be assessed at baseline
measure: Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care.
timeFrame: To be assessed 5 months after start of study
measure: Increase in proportion of caregivers seeking care for 2-59 months, old children with pneumonia, diarrhoea and fever from appropriate sources of care.
timeFrame: To be assessed 8 months after start of study
Secondary outcomes:
measure: Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
timeFrame: To be assessed at baseline
measure: Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
timeFrame: To be assessed 5 months after start of study
measure: Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
timeFrame: To be assessed 8 months after start of study
measure: Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
timeFrame: To be assessed at baseline
measure: Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
timeFrame: To be assessed 5 months after start of study
measure: Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
timeFrame: To be assessed 8 months after start of study
measure: 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
timeFrame: To be assessed at baseline
measure: 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
timeFrame: To be assessed 5 months after start of study
measure: 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
timeFrame: To be assessed 8 months after start of study
measure: Proportion of caregivers who complied with referral.
timeFrame: To be assessed at baseline
measure: Proportion of caregivers who complied with referral.
timeFrame: To be assessed 5 months after start of study
measure: Proportion of caregivers who complied with referral.
timeFrame: To be assessed 8 months after start of study
measure: Proportion of children treated by ANMs with injectable antibiotics.
timeFrame: To be assessed at baseline
measure: Proportion of children treated by ANMs with injectable antibiotics.
timeFrame: To be assessed 5 months after start of study
measure: Proportion of children treated by ANMs with injectable antibiotics.
timeFrame: To be assessed 8 months after start of study
measure: Proportion of times of families who tried to contact CHW and were unable to do so.
timeFrame: To be assessed at baseline
measure: Proportion of times of families who tried to contact CHW and were unable to do so.
timeFrame: To be assessed 5 months after start of study
measure: Proportion of times of families who tried to contact CHW and were unable to do so.
timeFrame: To be assessed 8 months after start of study
Other outcomes:
Locations:
city: Palwal
country: India
facility: CHRD, Society for Applied Studies
state: Haryana
Study officials:
affiliation: Centre for Health Research and Development, Society for Applied Studies
name: Sarmila Mazumder, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: