Evaluation of the Effectiveness and Impact of Community Case Management of Severe Acute Malnutrition
1 other identifier
interventional
762
1 country
1
Brief Summary
HYPOTHESIS: Investigators hypothesize that by provision of care at household level in a community through lady health workers will as effective (recovery rate, burden of SAM, cost effective, coverage) as through health care providers at facility level. OBJECTIVES
- 1.To evaluate the effectiveness (rate of recovery, burden \& coverage), of SAM standard management of children 06-59 months delivered at household level by first level health care providers (Lady health workers) compared with the standard CMAM program delivered at health facility by Govt./ACF staff.
- 2.To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt/ACF staff.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
1 active site
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
April 20, 2015
CompletedFirst Submitted
Initial submission to the registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
February 6, 2017
CompletedFebruary 6, 2017
February 1, 2017
1.2 years
November 11, 2015
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate rate of recovery
To evaluate the rate of recovery of SAM treatment of children 6-59 months old delivered at household level by first level health care providers (Lady Health workers) compared with the standard CMAM program delivered at health facility by Govt and ACF staff. Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.
18 months
Secondary Outcomes (4)
Prevalence of malnutrition
18 months
To evaluate the cost effectiveness of treatment.
18 months
Relapse from severe acute malnutrition
18 months
Default cases of SAM
18 months
Study Arms (2)
Group A (intervention)
EXPERIMENTAL'Management of SAM at home' LHWs will identify and treat all cases of severe acute malnutrition (SAM) as per the study eligibility criteria (MUAC \< 11.5 cm) and manage all cases of SAM without complications at home with 'Standard CMAM program'. The LHWs will also identify SAM with complications for further assessment to the BHU Doctor and subsequent referral to the stabilization center . They will also provide one to one health and Infant and Young Child Feeding (IYCF) counselling to care takers of children in their catchment area.
Group B (Control)
ACTIVE COMPARATOR'Management of SAM at facility' LHWs will identify SAM as per 'Standard CMAM program' (MUAC \< 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.
Interventions
LHWs will identify and treat all cases of severe acute malnutrition (SAM) in children under-five years at household level compared with the standard CMAM program
LHWs will identify SAM as per 'Standard CMAM program' (MUAC \< 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.
Eligibility Criteria
You may qualify if:
- Born in the study area
- Presence of severe acute malnutrition (SAM).
- Ability of the parents or guardians to provide informed consent.
You may not qualify if:
- Presence of chronic debilitating illness.
- Residence outside of study areas.
- Inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.
- Internally displaced population
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aga Khan Universitylead
- Action Contre la Faimcollaborator
Study Sites (1)
Aga Khan University Project Office
Khairpur Nathan Shah, Sindh, Pakistan
Related Publications (2)
Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6.
PMID: 23746776BACKGROUNDRogers E, Guerrero S, Kumar D, Soofi S, Fazal S, Martinez K, Moran JLA, Puett C. Evaluation of the cost-effectiveness of the treatment of uncomplicated severe acute malnutrition by lady health workers as compared to an outpatient therapeutic feeding programme in Sindh Province, Pakistan. BMC Public Health. 2019 Jan 17;19(1):84. doi: 10.1186/s12889-018-6382-9.
PMID: 30654780DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sajid Soofi, FCPS
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 11, 2015
First Posted
February 6, 2017
Study Start
April 20, 2015
Primary Completion
June 30, 2016
Study Completion
June 30, 2016
Last Updated
February 6, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share