Clinical trial NCT03140904: Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition
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 Surveillance for Access-limited and High-burden Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: Epicentre
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 3945
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Standard weekly visits at the outpatient therapeutic feeding center until discharge
2. 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Nutritional recovery
timeFrame: Minimum length of stay is 8 weeks
Secondary outcomes:
measure: Hospitalization
timeFrame: within 2 months
measure: Daily weight gain (g / kg / day) among recovered children
timeFrame: within 2 months
measure: Defaulting
timeFrame: within 2 months
measure: Relapse
timeFrame: Within 2 months
Other outcomes:
Locations:
city: Sokoto
country: Nigeria
facility: Sokoto State Nutrition Centre
Study officials:
affiliation: Epicentre
name: Rebecca GRAIS
role: STUDY_DIRECTOR
References:
citation: Hitchings MDT, Berthe F, Aruna P, Shehu I, Hamza MA, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial. PLoS Med. 2022 Mar 1;19(3):e1003923. doi: 10.1371/journal.pmed.1003923. eCollection 2022 Mar.
citation: Isanaka S, Hedt-Gauthier BL, Salou H, Berthe F, Grais RF, Allen BGS. Active and adaptive case finding to estimate therapeutic program coverage for severe acute malnutrition: a capture-recapture study. BMC Health Serv Res. 2019 Dec 16;19(1):967. doi: 10.1186/s12913-019-4791-9.