NCT02623166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

November 24, 2015

Last Update Submit

September 5, 2018

Conditions

Pneumonia, Diarrhea, Fever

Keywords

PneumoniaFeverDiarrhoea

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (18)

  • Knowledge and perceptions of caregivers about treatment from trained CHWs assessed by indepth interviews and focus group discussions

    To be assessed at baseline

  • 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

  • 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

  • Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires

    To be assessed at baseline

  • Experiences of CHW about themselves as treatment providers assessed by indepth interviews using questionnaires

    To be assessed 5 months after start of study

  • +13 more secondary outcomes

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • Children aged 2-59 months with uncomplicated pneumonia or diarrhoea or fever

You may not qualify if:

  • Refusal for participation
  • Diarrhea with dehydration
  • Danger signs
  • Chest indrawing pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRD, Society for Applied Studies

Palwal, Haryana, 121102, India

Location

MeSH Terms

Conditions

PneumoniaDiarrheaFever

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBody Temperature Changes

Study Officials

  • Sarmila Mazumder, MBBS, PhD

    Centre for Health Research and Development, Society for Applied Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 7, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Locations

IN(1)