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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Acute Malnutrition
- Sponsor
- Epicentre
- Enrollment
- 3945
- Locations
- 1
- Primary Endpoint
- Nutritional recovery
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Hospitalization(within 2 months)
- Relapse(Within 2 months)
- Daily weight gain (g / kg / day) among recovered children(within 2 months)
- Defaulting(within 2 months)