Maternal, Newborn and Child Health EmergenciesSimForLifeNCT03252275
Peer Learning and HBB in Managing Maternal Newborn and Child Health Emergencies in Rural Uganda
A study testing Peer learning in people with Maternal, Newborn and Child Health Emergencies, run by Mbarara University of Science and Technology.
Trial summary
The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maternal, Newborn and Child Health Emergencies
- What is being tested?
- Peer learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2017to Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Health workers involved in performing deliveries of mothers at health center IVs and IIIs (i.e, county and subcounty level)
Who cannot join
- Health facilities based in municipalities, urban dwellings
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Simulation Based Education With Peer Learning to Enhance HBB Training for Managing Maternal Newborn and Child Health Emergencies in Rural Uganda: A Cluster-randomized Trial
The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.
Read the detailed description
The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.
The cluster randomized study will have two arms; intervention arm receives peer learning program. In this program, two health workers at the same health facility teach each other using case scenarios. The case scenarios will be based on common neonatal conditions such as neonatal sepsis, hypothermia and prematurity.
The two study arms will both receive training on HBB and Essential care for every baby (ECEB)
- Being tested
- Peer learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer learningOther
Peer learning plus HBB and ECEB
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard HBB and ECEB training with peer learning Receives: Other: Peer learning |
| Control | No intervention | Standard HBB and ECEB training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skills on key maternal, newborn and child health emergency procedures
Ability to perform key maternal, new born and child health emergency procedures measured using Multiple choice questions (MCQs). A composite score with a maximum of 100% will be computed from these MCQs
Measured: Change in skills scores at 6 and 12 months from Baseline
Secondary outcomes (1)
Clinical teamwork scores
Ability to work as a team through communication, sharing roles and completing tasks together measured using the Clinical Teamwork scale (CTS). A composite score will be computed by adding up all the items on the CTS scale. CTS has 15 items, each item with a maximum score of 10
Measured: Change in CTS scores at 6 and 12 months from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start30 Aug 2017 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal, Newborn and Child Health EmergenciesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a parallel comparison of intervention and control arms to measure study endpoints
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Santorini Data, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252275
- Sponsor's protocol ID
- MUST 21/06-16
- Acronym
- SimForLife
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Authorization to share data will be sought
Publications
Data S, Mirette D, Cherop M, Bajunirwe F, Kyakwera C, Robinson T, Josephine NN, Abesiga L, Namata T, Brenner JL, Singhal N, Twine M, Wishart I, McIntosh H, Cheng A. Peer Learning and Mentorship for Neonatal Management Skills: A Cluster-Randomized Trial. Pediatrics. 2022 Aug 1;150(2):e2021054471. doi: 10.1542/peds.2021-054471.
PubMed 35794462
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Simulation Based Education With Peer Learning to Enhance HBB Training for Managing Maternal Newborn and Child Health Emergencies in Rural Uganda: A Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT03252275
- Acronym / sponsor ID
- SimForLife / MUST 21/06-16
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 30 Aug 2017 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Aug 2017 (actual)
- 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.
The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.
Detailed description
The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.
The cluster randomized study will have two arms; intervention arm receives peer learning program. In this program, two health workers at the same health facility teach each other using case scenarios. The case scenarios will be based on common neonatal conditions such as neonatal sepsis, hypothermia and prematurity.
The two study arms will both receive training on HBB and Essential care for every baby (ECEB)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a parallel comparison of intervention and control arms to measure study endpoints
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Peer learningStandard HBB and ECEB training with peer learning |
| Control | No intervention | –Standard HBB and ECEB training only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Health workers involved in performing deliveries of mothers at health center IVs and IIIs (i.e, county and subcounty level)
Key exclusion criteria (1 listed)
- Health facilities based in municipalities, urban dwellings
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 |
|---|---|---|
| Peer learningPeer learning plus HBB and ECEB | Other | Intervention |
Primary outcome
Skills on key maternal, newborn and child health emergency procedures
Time frame: Change in skills scores at 6 and 12 months from Baseline
Ability to perform key maternal, new born and child health emergency procedures measured using Multiple choice questions (MCQs). A composite score with a maximum of 100% will be computed from these MCQs
1 secondary outcome
Clinical teamwork scores
Time frame: Change in CTS scores at 6 and 12 months from Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Derived from this study: PubMed 35794462Data S, Mirette D, Cherop M, Bajunirwe F, Kyakwera C, Robinson T, Josephine NN, Abesiga L, Namata T, Brenner JL, Singhal N, Twine M, Wishart I, McIntosh H, Cheng A. Peer Learning and Mentorship for Neonatal Management Skills: A Cluster-Randomized Trial. Pediatrics. 2022 Aug 1;150(2):e2021054471. doi: 10.1542/peds.2021-054471.
- Individual participant dataSharing planned: Undecided. Authorization to share data will be sought
Related trials for Maternal, Newborn and Child Health Emergencies
Not yet recruitingObservational study
Evaluation of Comprehensive Emergency Obstetric and Neonatal Care Program in Malawi
Maternal and Child Health
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.
Santorini Data, MD principal investigator
Mbarara University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Peer learning in people with Maternal, Newborn and Child Health Emergencies, run by Mbarara University of Science and Technology.
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 1 inclusion and 1 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Santorini Data, MD (+256752214458, sdata@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skills on key maternal, newborn and child health emergency procedures (time frame: Change in skills scores at 6 and 12 months from Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252275, which also lists 1 linked publication.
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 17 Aug 2017.