Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition

Overview

This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

Full Title of Study: “Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2019

Detailed Description

This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance. Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance. Regardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.

Interventions

  • Other: Standard weekly visits
    • Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge
  • Other: Monthly visits
    • Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge

Arms, Groups and Cohorts

  • Other: Standard weekly visits
    • Standard weekly visits at the outpatient therapeutic feeding center until discharge
  • Other: Monthly visits
    • Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge

Clinical Trial Outcome Measures

Primary Measures

  • Nutritional recovery
    • Time Frame: Minimum length of stay is 8 weeks
    • Defined by being free from medical complications, MUAC > 125 mm, and no edema for 2 weeks if admitted with edema

Secondary Measures

  • Hospitalization
    • Time Frame: within 2 months
    • Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care
  • Daily weight gain (g / kg / day) among recovered children
    • Time Frame: within 2 months
    • difference in weight (g)
  • Defaulting
    • Time Frame: within 2 months
    • 3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group
  • Relapse
    • Time Frame: Within 2 months
    • Maternal report of admission to any therapeutic feeding program

Participating in This Clinical Trial

Inclusion Criteria

  • age from 6 to 59 months – MUAC < 115 mm and/or grade 1-2 edema – Absence of current illness requiring inpatient care Exclusion Criteria:

  • History of allergy to peanuts – Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent

Gender Eligibility: All

Minimum Age: 6 Weeks

Maximum Age: 59 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Epicentre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rebecca GRAIS, Study Director, Epicentre

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