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

Epicentre

Status: Completed

Conditions: Severe Acute Malnutrition

Treatments: Other: Monthly visits; Other: Standard weekly visits

Study type: Interventional

Funder types: Other

Identifiers

NCT03140904

Reduced follow-up

Details and patient eligibility

About

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 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.

Enrollment: 3,945 patients

Sex: All

Ages: 6 to 59 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,945 participants in 2 patient groups

Standard weekly visits

Other group

Description:

Standard weekly visits at the outpatient therapeutic feeding center until discharge

Treatment:

Other: Standard weekly visits

Monthly visits

Other group

Description:

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

Treatment:

Other: Monthly visits