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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Surveillan

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Epicentre

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Epicentre

Dates:
Date Received: April 28, 2017
Date Started: July 1, 2017
Date Completion: June 30, 2019
Last Updated: May 3, 2017
Last Verified: May 2017