Malnutrition, ChildNCT03044548
Improving the Quality of Care for Children With Acute Malnutrition in Uganda
A study testing Supportive supervision in people with Malnutrition, Child, run by WHO Collaborating Centre for Maternal and Child Health, Trieste at 1 site in Uganda.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Supportive supervision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUganda
- Study dates
- Dec 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6 months-5 years
- 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 .
Who cannot join
- Not matching the above criteria for SAM and MAM
- Refusal to participate/ consent
- Unable to adhere to study follow up procedures
Trial locations and contacts
1 site in 1 country.
Marzia Lazzerini, PhD contact
Humphrey Wanzira, MSc contact
Uganda1 site, 1 recruiting
- Recruiting
Arua district
Arua
Humphrey Wanzira, Msc
humphrey.wanzira@burlo.trieste.it
About this study
Official title: Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda
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
Read the 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.
- Conditions
- Malnutrition, Child
- Being tested
- Supportive supervision
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive supervisionOther
" 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 .
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Supportive supervision Receives: Other: Supportive supervision |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
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.
Measured: 12- 16 weeks
Secondary outcomes (9)
Dead rate
cases explicitly state as " dead" while in the program
Measured: 12- 16 weeks
Rate of Not cured
Has not reached Cured/discharged criteria in 3 months (4 months for HIV +)
Measured: 12- 16 weeks
Rate of transferred to ITC (inpatient treatment center)
Patients transferred to another outpatient service
Measured: 12- 16 weeks
Rate of transferred to OTC (outpatient treatment center)
Patients transferred to another outpatient service
Measured: 12- 16 weeks
Rate of defaulted
Absent (Not reported or followed up in the community) for 2 consecutive visits.
Measured: 12- 16 weeks
Quality of data
This will be measured by cross-checking data collected from the study data collectors, and data as reported by the staff of the HC
Measured: study start, than every month up to 15 months
Equity outcomes
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
Measured: study start, than every month up to 15 months
Cost
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).
Measured: study start, than every month up to 15 months
Staff satisfaction score
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)
Measured: study start, month 6 and month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WHO Collaborating Centre for Maternal and Child Health, Trieste
- Sponsor type
- University, hospital or other
- Collaborators
- CUAMM Doctors for Africa
- Responsible party
- Principal investigator, Marzia Lazzerini, WHO Collaborating Centre for Maternal and Child Health, Trieste
- Investigators
- Marzia Lazzerini, PhD, Principal investigator, WHO CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044548
- Sponsor's protocol ID
- Prot 521/2016
- Status last verified
- Feb 2017
- First submitted
- 20 Dec 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda
- ClinicalTrials.gov ID
- NCT03044548
- Acronym / sponsor ID
- Prot 521/2016
- Conditions
- Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- WHO Collaborating Centre for Maternal and Child Health, TriesteUniversity, hospital or other
- Collaborators
- CUAMM Doctors for Africa
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Supportive supervisionSupportive supervision |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 6 months-5 years
- 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 .
Key exclusion criteria (3 listed)
- Not matching the above criteria for SAM and MAM
- Refusal to participate/ consent
- Unable to adhere to study follow up procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 . | Other | Experimental |
Primary outcome
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.
9 secondary outcomes
Dead rate
Time frame: 12- 16 weeks
Rate of Not cured
Time frame: 12- 16 weeks
Rate of transferred to ITC (inpatient treatment center)
Time frame: 12- 16 weeks
Rate of transferred to OTC (outpatient treatment center)
Time frame: 12- 16 weeks
Rate of defaulted
Time frame: 12- 16 weeks
Quality of data
Time frame: study start, than every month up to 15 months
Equity outcomes
Time frame: study start, than every month up to 15 months
Cost
Time frame: study start, than every month up to 15 months
Staff satisfaction score
Time frame: study start, month 6 and month 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzia Lazzerini, PhD contact
Humphrey Wanzira, MSc contact
Marzia Lazzerini, PhD principal investigator
WHO CC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive supervision in people with Malnutrition, Child, run by WHO Collaborating Centre for Maternal and Child Health, Trieste at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marzia Lazzerini, PhD (marzia.lazzerini@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: 12- 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.