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To Assess the Effectiveness of Various Communication Strategies for Improving Childhood Pneumonia Case Management: A Community Based Behavioral Open Labeled Trial in Rural Lucknow, Uttar Pradesh, India
Last registered on September 19, 2018

Pre-Trial

Trial Information
General Information
Title
To Assess the Effectiveness of Various Communication Strategies for Improving Childhood Pneumonia Case Management: A Community Based Behavioral Open Labeled Trial in Rural Lucknow, Uttar Pradesh, India
RCT ID
AEARCTR-0003137
Initial registration date
July 10, 2018
Last updated
September 19, 2018 12:10 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
King George's Medical University
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2015-10-15
End date
2018-09-30
Secondary IDs
Abstract
Title of the research proposal project
To Assess the Effectiveness of Various Communication Strategies for Improving Childhood Pneumonia Case Management: A Community Based Behavioral Open Labeled Trial in Rural Lucknow, Uttar Pradesh, India

Executive Summary
Background: Community Acquired Pneumonia (CAP) is the leading cause of childhood morbidity and mortality worldwide and in India. Many of these deaths can be averted by creating awareness in the community about early symptoms of CAP and by ensuring availability of round the clock, quality health care.

Hypothesis
Strengthening of public health system to provide sustainable quality care for cases of childhood pneumonia (CAP) followed by strategic dissemination of validated messages to community may improve care seeking behavior for CAP within 12 months that can be measured by 50% improved utilization of services from qualified public health care providers (over the current utilization rate of 25%).

Primary Objective 1
To assess the effectiveness of an innovative package of “Community Orientation” of doctors and ANMs and ASHAs, PLUS infrastructural strengthening by (i) providing “Pneumonia Drug Kit” (PDK) (ii) establishing “Pneumonia Management Corner” (PMC) at Primary Health Center (PHC) and (iii) “Pneumonia Management Unit” (PMU) at Community Health Center (CHC) ALONG with one of the 4 different behavior change communication interventions:

Intervention 1: Organizing Childhood Pneumonia Awareness Sessions (PAS) for caregivers of children <5 years of age during a routine immunization day, using self-developed and validated IEC materials, in APHCs and CHC monthly, conducted by a trained ANM and project facilitator.

Intervention 2: Organizing PAS on Village Health and Nutrition Day (V.H.N.D.) only once a month by the ASHA worker trained for this.

Intervention 3: Combination of Both Intervention 1& 2

Intervention 4: Usual Care

On: Number of clinical pneumonia cases-treated by ANMs/doctors with medicines from PDK OR Treated at either PMC or PMU

Primary Objective 2
To ascertain change, if any, in the types of health care providers’ service utilization for acute respiratory illness (ARI)/CAP in last one year in children less than 5 years pre and post intervention.

Research Design
A prospective Community Based Open Labeled Behavioral Trial conducted in 2 by 2 factorial design in 8 rural blocks of Lucknow district after (a) capacity building of doctors, ANMs and ASHA workers by conducting training sessions and (b) establishing of PMC, PMU and distribution of PDK and ensuring other infra-structural up-gradation for facility based management of CAP. Health facility audits will be done to collect information on process indicators, i.e., (i) utilization of PDK, PMC and PMC and (ii) conduct of PAS sessions in APHC, CHC and/or during V.H.N.D. monthly. This will give also information for the primary objective 1. Community survey will be done by multistage cluster sampling to collect information on changes in the types of health care providers’ service utilization for ARI/CAP pre and post intervention.

Data Management
Data will be managed on MS-Excel. Data analysis will be done on SPSS. Tests of proportion will be applied to compare outcomes across the 4 intervention arms.

Implications
The project will build public health infrastructure for managing CAP. It will also bring about a positive change in the community behavior when confronted with a case of CAP. This will improve quality of care of CAP and thus result in reduced mortality in Lucknow district. Since the work will be done in partnership with the government, it can be scaled up and thus will result in reduced infant and under-fives mortality rate and help in achieving MDG 4.
External Link(s)
Registration Citation
Citation
Awasthi, Shally. 2018. "To Assess the Effectiveness of Various Communication Strategies for Improving Childhood Pneumonia Case Management: A Community Based Behavioral Open Labeled Trial in Rural Lucknow, Uttar Pradesh, India." AEA RCT Registry. September 19. https://doi.org/10.1257/rct.3137-2.0.
Former Citation
Awasthi, Shally. 2018. "To Assess the Effectiveness of Various Communication Strategies for Improving Childhood Pneumonia Case Management: A Community Based Behavioral Open Labeled Trial in Rural Lucknow, Uttar Pradesh, India." AEA RCT Registry. September 19. http://www.socialscienceregistry.org/trials/3137/history/34374.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Intervention 1
Organizing Childhood Pneumonia Awareness Sessions (PAS) for caregivers of children <5 years of age during a routine immunization day, using self-developed and validated IEC materials, in Primary Health Centers and Community Health Centers monthly, conducted by a trained Auxillary Nurse & Midwife and project facilitator.

Intervention 2
Organizing PAS on Village Health and Nutrition Day (V.H.N.D.) once a month by the Accredited Social Health Activist worker trained for this.

Intervention 3
Combination of Both Intervention 1& 2

Intervention 4
Usual Care
Intervention Start Date
2016-09-01
Intervention End Date
2017-12-20
Primary Outcomes
Primary Outcomes (end points)
Number of clinical pneumonia cases-
•Treated by ANMs/doctors with medicines from Pneumonia Drug Kit OR
•Treated at either Pneumonia Management Corner or Pneumonia Management Unit
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
To ascertain change, if any, in the types of health care providers’ service utilization for Acute Respiratory Illness (ARI)/CAP in last 12 months in children less than 5 years pre and post intervention.
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
A prospective Community Based Open Labeled Behavioral Trial conducted in 2 by 2 factorial design in 8 rural blocks of Lucknow district after (a) capacity building of doctors, ANMs and ASHA workers by conducting training sessions and (b) establishing of PMC, PMU and distribution of PDK and ensuring other infra-structural up-gradation for facility based management of CAP. Health facility audits will be done to collect information on process indicators, i.e., (i) utilization of PDK, PMC and PMC and (ii) conduct of PAS sessions in APHC, CHC and/or during V.H.N.D. monthly. This will give also information for the primary objective 1. Community survey will be done by multistage cluster sampling to collect information on changes in the types of health care providers’ service utilization for ARI/CAP pre and post intervention.
Experimental Design Details
Randomization Method
Simple Randomization (Used ASHA's register to select households)
Randomization Unit
Household
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
In each block 30 villages were selected and from each village 10 households were selected.
So From each Block we selected 300 Households.
Overall 2400 households has been selected from 8 blocks.
Sample size: planned number of observations
2400 households
Sample size (or number of clusters) by treatment arms
600 households in Intervention 1
600 households in Intervention 2
600 households in Intervention 3
600 households in Intervention 4
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Institutional Ethics Committee, King George Medical University, Lucknow
IRB Approval Date
2015-02-13
IRB Approval Number
3692/Ethics/R.Cell-15
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS