Evaluation of the Effectiveness and Impact of Community Case Management of Severe Acute Malnutrition Through Lady Health Workers As Compared To a Facility Based Program: A Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 762
- Locations
- 1
- Primary Endpoint
- To evaluate rate of recovery
Study Overview
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
- 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.
- 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.
STUDY DESIGN:
Cluster randomized controlled trial
SAMPLE SIZE & RANDOMIZATION:
Investigators took 6% prevalence to calculate the sample size with an expected reduction of 20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY METHODOLOGY Intervention (Group A): 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 following the national CMAM guidelines. Control (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC < 11.5 cm) and will refer all cases to the health facility (ACF) for further management and counselling by health workers at facility.
Detailed Description
INTRODUCTION & RATIONALE:
There is good evidence of the success of CMAM programs for treating SAM in emergencies and humanitarian crises [1], but little regarding the most cost effective mechanisms to deliver it or of the added value of integrating treatment of acute malnutrition with treatment of common childhood illness and/or extensive communitybased nutritional program.
HYPOTHESIS:
Provision of SAM treatment at household level in a community through lady health workers will be as effective (recovery rate, survival, cost effectiveness, coverage) as treatment provided at facility level.
RESEARCH QUESTION:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Born in the study area
- •Presence of severe acute malnutrition (SAM).
- •Ability of the parents or guardians to provide informed consent.
Exclusion Criteria
- •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
Arms & Interventions
Group A (intervention)
'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.
Intervention: Management of SAM at home (Dietary Supplement)
Group B (Control)
'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.
Intervention: Management of SAM at facility (Dietary Supplement)
Outcomes
Primary Outcomes
To evaluate rate of recovery
Time Frame: 18 months
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.
Secondary Outcomes
- To evaluate the cost effectiveness of treatment.(18 months)
- Prevalence of malnutrition(18 months)
- Relapse from severe acute malnutrition(18 months)
- Default cases of SAM(18 months)
Investigators
Dr Sajid Bashir Soofi
Associate Professor
Aga Khan University