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Trial record 19 of 3477 for:    Facility

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

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ClinicalTrials.gov Identifier: NCT03043352
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Action Contre la Faim
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, Aga Khan University

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.

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.


Condition or disease Intervention/treatment Phase
Severe Malnutrition Dietary Supplement: Management of SAM at home Dietary Supplement: Management of SAM at facility Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 762 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 20, 2015
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevalence of malnutrition [ Time Frame: 18 months ]
    It will be estimated through cross sectional surveys.

  2. To evaluate the cost effectiveness of treatment. [ Time Frame: 18 months ]
    To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt and ACF staff.

  3. Relapse from severe acute malnutrition [ Time Frame: 18 months ]

    To evaluate the relapse 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.


  4. Default cases of SAM [ Time Frame: 18 months ]
    Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043352


Locations
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Pakistan
Aga Khan University Project Office
Khairpur Nathan Shah, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
Action Contre la Faim
Investigators
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Principal Investigator: Sajid Soofi, FCPS Aga Khan University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03043352     History of Changes
Other Study ID Numbers: 3276-Ped-ERC-14
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Sajid Bashir Soofi, Aga Khan University:
SAM
Malnutrition
LHW
CMAM
Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders