NCT03043352

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

Completed NA Last updated 6 February 2017

What this trial tests

NA trial testing Management of SAM at home in Severe Malnutrition in 762 participants. Completed in 30 June 2016.

Timeline

20 April 2015

Primary endpoint
30 June 2016

30 June 2016

Quick facts

Lead sponsor	Aga Khan University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	762
Start date	20 April 2015
Primary completion	30 June 2016
Estimated completion	30 June 2016
Sites	1 location across Pakistan

Drugs / interventions tested

• Management of SAM at home
• Management of SAM at facility

Conditions studied

• Severe Malnutrition — all drugs for Severe Malnutrition →

Sponsor

Aga Khan University

Who can join

Adults 6 Months to 59 Months, any sex, with Severe Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Rogers E, Guerrero S, Kumar D, Soofi S, et al · · 2019 · cited 20× · PMID 30654780 · DOI 10.1186/s12889-018-6382-9
2. Lay health workers in primary and community health care for maternal and child health: identification and treatment of wasting in children.
   Papadopoulou E, Lim YC, Chin WY, Dwan K, et al · · 2023 · cited 2× · PMID 37646367 · DOI 10.1002/14651858.cd015311