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Evaluation of the Effectiveness and Impact of Community Case Management of Severe Acute Malnutrition

NCT03043352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 762

Last updated 2017-02-06

No results posted yet for this study

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.

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.

Conditions

  • Severe Malnutrition

Interventions

DIETARY_SUPPLEMENT

Management of SAM at home

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

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Action Contre la Faim

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Sajid Soofi, FCPS · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-20
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043352 on ClinicalTrials.gov