Pneumonia, Diarrhea, FeverNCT02623166
Treatment of Pneumonia, Diarrhoea and Fever in Children by Community Health Workers
An observational study of Pneumonia, Diarrhea, Fever, run by Society for Applied Studies at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 2 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Diarrhea, Fever
- How many people
- 24,000 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2015to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- Children aged 2-59 months with uncomplicated pneumonia or diarrhoea or fever
Who cannot join
- Refusal for participation
- Diarrhea with dehydration
- Danger signs
- Chest indrawing pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia, Diarrhea, Fever
- Keywords
- Pneumonia, Fever, Diarrhoea
- Medical subject headings
- Pneumonia, Diarrhea, Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: To be assessed 8 months after start of study
Secondary outcomes (18)
Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
Measured: To be assessed at baseline
Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions
Measured: 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
Measured: To be assessed 8 months after start of study
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Measured: To be assessed at baseline
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Measured: To be assessed 5 months after start of study
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Measured: 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
Measured: 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
Measured: 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
Measured: To be assessed 8 months after start of study
Proportion of caregivers who complied with referral.
Measured: To be assessed at baseline
Proportion of caregivers who complied with referral.
Measured: To be assessed 5 months after start of study
Proportion of caregivers who complied with referral.
Measured: To be assessed 8 months after start of study
Proportion of children treated by ANMs with injectable antibiotics.
Measured: To be assessed at baseline
Proportion of children treated by ANMs with injectable antibiotics.
Measured: To be assessed 5 months after start of study
Proportion of children treated by ANMs with injectable antibiotics.
Measured: 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.
Measured: To be assessed at baseline
Proportion of times of families who tried to contact CHW and were unable to do so.
Measured: 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.
Measured: To be assessed 8 months after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Diarrhea, FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 24,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
- Investigators
- Sarmila Mazumder, MBBS, PhD, Principal investigator, Centre for Health Research and Development, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623166
- Sponsor's protocol ID
- 2015/517094-0
- Other IDs
- 2015
- Status last verified
- Sep 2018
- First submitted
- 24 Nov 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Operationalise the Policy of Treating Uncomplicated Pneumonia, Diarrhoea and Fever in Children Aged 2-59 Months by Community Health Workers(CHW)
- ClinicalTrials.gov ID
- NCT02623166
- Acronym / sponsor ID
- 2015/517094-0
- Conditions
- Pneumonia, Diarrhea, Fever
- Keywords
- Pneumonia, Fever, Diarrhoea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,000 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (1 listed)
- Children aged 2-59 months with uncomplicated pneumonia or diarrhoea or fever
Key exclusion criteria (4 listed)
- Refusal for participation
- Diarrhea with dehydration
- Danger signs
- Chest indrawing pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
18 secondary outcomes
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
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
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
Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires
Time frame: 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
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
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
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
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
Proportion of caregivers who complied with referral.
Time frame: To be assessed at baseline
Proportion of caregivers who complied with referral.
Time frame: 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
Proportion of children treated by ANMs with injectable antibiotics.
Time frame: 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
Proportion of children treated by ANMs with injectable antibiotics.
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarmila Mazumder, MBBS, PhD principal investigator
Centre for Health Research and Development, Society for Applied Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Diarrhea, Fever, run by Society for Applied Studies at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: To be assessed at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.