Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving the Quality of Care for Children With Acute Malnutrition in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044548
Recruitment Status : Unknown
Verified February 2017 by Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
CUAMM Doctors for Africa
Information provided by (Responsible Party):
Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste

Brief Summary:
This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to improve health outcomes and quality of care of children with malnutrition

Condition or disease Intervention/treatment Phase
Malnutrition, Child Other: Supportive supervision Not Applicable

Detailed Description:

Introduction Malnutrition in children is highly prevalent in West Nile Region. According to a recent analysis of data available from the health management information system (HMIS) and official registers, the health outcomes of children suffering from malnutrition and treated at health center (HC) level in Arua Region are not reaching the international standards (75% cured rate as for the international SPHERE standards). This despite the availability of clear national guidelines for treatment, thus suggesting possible deficiencies in the quality of care provided. Lack of supportive supervision may be one of the reason explaining substandard outcomes.

Methods This is a cluster randomised controlled trail (RCT) with health centers (HC) as unit of randomisation. The six largest HC in Arua district will be randomised in two groups, intervention (quality improvement group) and control. The intervention will aim at improving the quality of care provided at HC level, and as a consequence, the health outcomes of children. The main intervention will consist of enhances nutritional supervision (high frequency supervision, specific to nutritional services), while the control will be standard care (no intervention). Complementary intervention will include training and networking activities for HC staff. Outcomes of the study will include: health outcomes (recovered, non recovered, defaulters, transferred, died); process outcomes (satisfaction and knowledge of staff); cost outcomes (cost for the health system and for the families) and equity outcomes (access to care and health outcomes by wealth quintile).

Relevance of the study The study will inform, with a robust design, about the efficacy and cost-efficacy of a quality improvement intervention for ameliorating the health of children suffering from malnutrition in Uganda.

Currently no other study with RCT design explored the efficacy of supportive supervision as a quality improvement intervention. This study will therefore fill an important knowledge gap.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Experimental
Supportive supervision
Other: Supportive supervision

" Supportive supervision". The specific characteristics of the supportive supervision as intended in this project are outlined below.

Frequency: Biweekly in the first 3-5 months, than monthly. Duration: approximately 2 hours in each HC at each visit. Provider: local staff (nutritionist, DHO) trained in integrated management acute malnutrition (IMAM) guidelines and in methods of " supportive supervision".

Receivers: nurses working at HC level with children with malnutrition.

Reference guidelines:

• Current National IMAM guidelines

Attitude and philosophy:

• Participatory peer-to-peer model based on the Plan - Do- Study- Act quality improvement (QI) Cycle .


No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Cure rate [ Time Frame: 12- 16 weeks ]
    Rate of cured among children diagnosed with acute malnutrition (SAM and MAM) Cured/discharged is defined as Weight-for-height > -2 standard deviation (SD) from the mean based on the World Health Organisation (WHO) 2006 standards (11) on 2 consecutive visits and no oedema.


Secondary Outcome Measures :
  1. Dead rate [ Time Frame: 12- 16 weeks ]
    cases explicitly state as " dead" while in the program

  2. Rate of Not cured [ Time Frame: 12- 16 weeks ]
    Has not reached Cured/discharged criteria in 3 months (4 months for HIV +)

  3. Rate of transferred to ITC (inpatient treatment center) [ Time Frame: 12- 16 weeks ]
    Patients transferred to another outpatient service

  4. Rate of transferred to OTC (outpatient treatment center) [ Time Frame: 12- 16 weeks ]
    Patients transferred to another outpatient service

  5. Rate of defaulted [ Time Frame: 12- 16 weeks ]
    Absent (Not reported or followed up in the community) for 2 consecutive visits.

  6. Quality of data [ Time Frame: study start, than every month up to 15 months ]
    This will be measured by cross-checking data collected from the study data collectors, and data as reported by the staff of the HC

  7. Equity outcomes [ Time Frame: study start, than every month up to 15 months ]
    access to care (supposing that the total population in the coverage area will not change in the intervention period, this will be measured by the crude number of children accessing the HC; efforts will also be made to retrieve, if available, accurate data on changes in the population in the coverage area

  8. Cost [ Time Frame: study start, than every month up to 15 months ]
    Data on cost from the patients (cost of travels to HC, cost of drugs, lab exams etc) and cost for the health services (number of visits in the HC, hospitalisations, foods and other treatments delivered).

  9. Staff satisfaction score [ Time Frame: study start, month 6 and month 15 ]
    This will be measured in all staff working with children with malnutrition in the HC participating in the study, using a score system pre-validated for use in Uganda (Hagopian et al, 2014)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For the primary outcomes, the study sample will consists of children with malnutrition treated at in health center (HC) in Arua district

Inclusion Criteria:

  1. Children 6 months-5 years
  2. Diagnosis of SAM or MAM according to National criteria (10) SAM: weight-for-height <- 3 standard deviation (SD) from the mean based on the WHO 2006 standards (11).

MAM: weight-for-height <- 2 and > -3 standard deviation (SD) from the mean based on the WHO 2006 growth reference standards .

Exclusion Criteria:

  1. Not matching the above criteria for SAM and MAM
  2. Refusal to participate/ consent
  3. Unable to adhere to study follow up procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044548


Contacts
Layout table for location contacts
Contact: Marzia Lazzerini, PhD marzia.lazzerini@burlo.trieste.it
Contact: Humphrey Wanzira, MSc humphrey.wanzira@burlo.trieste.it

Locations
Layout table for location information
Uganda
Arua district Recruiting
Arua, Uganda
Contact: Humphrey Wanzira, Msc         
Contact       humphrey.wanzira@burlo.trieste.it   
Sponsors and Collaborators
WHO Collaborating Centre for Maternal and Child Health, Trieste
CUAMM Doctors for Africa
Investigators
Layout table for investigator information
Principal Investigator: Marzia Lazzerini, PhD WHO CC

Layout table for additonal information
Responsible Party: Marzia Lazzerini, PhD, WHO Collaborating Centre for Maternal and Child Health, Trieste
ClinicalTrials.gov Identifier: NCT03044548    
Other Study ID Numbers: Prot 521/2016
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Child Nutrition Disorders
Nutrition Disorders