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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 762
- 试验地点
- 1
- 主要终点
- To evaluate rate of recovery
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born in the study area
- •Presence of severe acute malnutrition (SAM).
- •Ability of the parents or guardians to provide informed consent.
排除标准
- •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
结局指标
主要结局
To evaluate rate of recovery
时间窗: 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.
次要结局
- 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)
研究者
Dr Sajid Bashir Soofi
Associate Professor
Aga Khan University