TrainingLDHF-NigeriaNCT03269240
Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Study in Nigeria
A study testing Acquisition of Knowledge and clinical skills, Onsite training and Off-site training in people with Training and Capacity Building, run by Jhpiego.
Trial summary
The aim of this study is to compare the effectiveness and cost of a simulation-based low dose high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training approaches in improving knowledge and skill in maternal and newborn care and to determine trainees' satisfaction with the approaches… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Training, Capacity Building, Satisfaction
- What is being tested?
- Acquisition of Knowledge and clinical skills, Onsite training and Off-site training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2016to 29 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give informed consent to participate in the study;
- Must have spent at least six months in maternal and/or newborn care services;
- Must be providing services related to maternal and newborn health in selected health facilities at the time of the interview;
- Must be available to participate in the training from the beginning to the end; and
- Must have had pre-service training not incorporating simulation-based LDHF approach from accredited medical schools, schools of nursing/midwifery or health technology.
Who cannot join
- Decides to opt out / declines to participate.
- Has had prior training using the simulation-based LDHF approach.
- Provides services related to maternal and newborn health more than one health facility selected as part of intervention or comparison group.
About this study
Official title: A Comparative Study of Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Versus Traditional Group-based Training Approaches Among Maternal and Newborn Healthcare Providers in Ebonyi and Kogi States, Nigeria
The aim of this study is to compare the effectiveness and cost of a simulation-based low dose high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training approaches in improving knowledge and skill in maternal and newborn care and to determine trainees' satisfaction with the approaches in Ebonyi and Kogi states.
The specific objectives are to:
- Compare knowledge and skill learning outcomes between the two groups of birth attendants trained through the simulation-based LDHF/m-Mentoring versus group-based training approaches in Kogi and Ebonyi states over 12-months.
- Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi state over 12-months.
- Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi state over 12-months.
Read the detailed description
Simulation-based low dose high frequency (LDHF) training has emerged as a new strategy for delivering key content and improving the competencies of health workers. In facility-based driven simulation-based LDHF trainings, providers are not removed from clinical practice for the extended periods of time, and a heavy emphasis is placed on simulation with practice and feedback.
The Maternal and Child Survival Program (MCSP) in Nigeria is working in selected health facilities in Ebonyi and Kogi States to improve the quality of care received by mothers and newborns on the day of birth using high-impact evidence-based lifesaving interventions. The simulation-based LDHF/m-Mentoring evaluation comparing it to the traditional group-based training will contribute to the body of knowledge on this approach.
The study design is cluster randomized control trial. Sixty (60) health facilities will be selected from the list of 120 facilities which are supported by MCSP and randomized to intervention and control group. Selection will be based on caseload, level of service delivery, and ownership. Thereafter, these will be randomly assigned to simulation-based LDHF/m-Mentoring Group (intervention arm) or Group-Based Training Group (control arm).
- Conditions
- Training, Capacity Building, Satisfaction
- Being tested
- Acquisition of Knowledge and clinical skills, Onsite training, Off-site training
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of Knowledge and clinical skillsBehavioural
LDHF is a novel training approach that is being compared to the traditional training approach
Onsite trainingOther
Participants are training at their health facilities
Off-site trainingOther
Participants from different health facilities are gathered together in a central location for training, away from their workplaces
| Study group | Role | What they receive |
|---|---|---|
| LDHF plus m-Mentoring | Experimental | Participants will undergo pre-training assessment comprising multiple-choice questions and objective structured clinical examination (OSCE) using manikins. Training is divided into two 4-day "low-dose" sessions at the health facility or onsite training. Pre-training and immediate post-training assessments results will be compared. A score of ≥80% is acceptable competence (pass). During the one-month intervals between training sessions, participants practice using manikins to reinforce their competencies through simulation-based practices, facilitated by facility-based trained Peer Practice Coordinators (PPCs). The PPCs will also receive structured, monthly half-hour mentoring calls that will provide remote support, answering questions, providing guidance and reinforcing key messages. Acquisition of knowledge and clinical skills is measured. Receives: Behavioral: Acquisition of Knowledge and clinical skills; Other: Onsite training |
| Traditional training | Active comparator | The health providers will receive the same content of training in eight days, Off-site training, the way it's currently done in Nigeria. Both theoretical and practical through use of manikins - simulation. No reinforcement and further practice will take place once the participants are back in their work stations. Acquisition of knowledge and clinical skills is measured. Receives: Behavioral: Acquisition of Knowledge and clinical skills; Other: Off-site training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in competency in basic obstetric and emergency care between the groups
Proportion of competent providers who retain clinical competency skills 3 months post-training
Measured: 3 months
Secondary outcomes (3)
Comparison of retention of skills between the two study arms
Proportion of service providers who retain clinical competency skills after 12 months
Measured: 12 months
Level of satisfaction of service providers
Proportion of service providers who are satisfied with the training approach
Measured: 12 months
Comparison of cost-effectiveness of the two approaches
Cost-effectiveness of LDHF/m-Mentoring compared to group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi states.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start17 Sep 2016
- Primary completion24 Mar 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TrainingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Otolorin, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269240
- Sponsor's protocol ID
- IRB00007196
- Acronym
- LDHF-Nigeria
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2017
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have access.
Publications
Ugwa E, Kabue M, Otolorin E, Yenokyan G, Oniyire A, Orji B, Okoli U, Enne J, Alobo G, Olisaekee G, Oluwatobi A, Oduenyi C, Aledare A, Onwe B, Ishola G. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings among health workers on day of birth care in Nigeria; a cluster randomized controlled trial. BMC Health Serv Res. 2020 Jun 26;20(1):586. doi: 10.1186/s12913-020-05450-9.
PubMed 32590979Ugwa E, Otolorin E, Kabue M, Ishola G, Evans C, Oniyire A, Olisaekee G, Onwe B, LeFevre AE, Bluestone J, Orji B, Yenokyan G, Okoli U. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based training approaches on day of birth care among maternal and newborn healthcare providers in Ebonyi and Kogi States, Nigeria; a randomized controlled trial. BMC Health Serv Res. 2018 Aug 13;18(1):630. doi: 10.1186/s12913-018-3405-2.
PubMed 30103761
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Versus Traditional Group-based Training Approaches Among Maternal and Newborn Healthcare Providers in Ebonyi and Kogi States, Nigeria
- ClinicalTrials.gov ID
- NCT03269240
- Acronym / sponsor ID
- LDHF-Nigeria / IRB00007196
- Conditions
- Training, Capacity Building, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 31 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 compare the effectiveness and cost of a simulation-based low dose high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training approaches in improving knowledge and skill in maternal and newborn care and to determine trainees' satisfaction with the approaches in Ebonyi and Kogi states.
The specific objectives are to:
- Compare knowledge and skill learning outcomes between the two groups of birth attendants trained through the simulation-based LDHF/m-Mentoring versus group-based training approaches in Kogi and Ebonyi states over 12-months.
- Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi state over 12-months.
- Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi state over 12-months.
Detailed description
Simulation-based low dose high frequency (LDHF) training has emerged as a new strategy for delivering key content and improving the competencies of health workers. In facility-based driven simulation-based LDHF trainings, providers are not removed from clinical practice for the extended periods of time, and a heavy emphasis is placed on simulation with practice and feedback.
The Maternal and Child Survival Program (MCSP) in Nigeria is working in selected health facilities in Ebonyi and Kogi States to improve the quality of care received by mothers and newborns on the day of birth using high-impact evidence-based lifesaving interventions. The simulation-based LDHF/m-Mentoring evaluation comparing it to the traditional group-based training will contribute to the body of knowledge on this approach.
The study design is cluster randomized control trial. Sixty (60) health facilities will be selected from the list of 120 facilities which are supported by MCSP and randomized to intervention and control group. Selection will be based on caseload, level of service delivery, and ownership. Thereafter, these will be randomly assigned to simulation-based LDHF/m-Mentoring Group (intervention arm) or Group-Based Training Group (control arm).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized control trial
| Arm | Type | Receives |
|---|---|---|
| LDHF plus m-Mentoring | Experimental | Behavioral: Acquisition of Knowledge and clinical skills, Other: Onsite trainingParticipants will undergo pre-training assessment comprising multiple-choice questions and objective structured clinical examination (OSCE) using manikins. Training is divided into two 4-day "low-dose" sessions at the health facility or onsite training. Pre-training and immediate post-training assessments results will be compared. A score of ≥80% is acceptable competence (pass). During the one-month intervals between training sessions, participants practice using manikins to reinforce their competencies through simulation-based practices, facilitated by facility-based trained Peer Practice Coordinators (PPCs). The PPCs will also receive structured, monthly half-hour mentoring calls that will provide remote support, answering questions, providing guidance and reinforcing key messages. Acquisition of knowledge and clinical skills is measured. |
| Traditional training | Active comparator | Behavioral: Acquisition of Knowledge and clinical skills, Other: Off-site trainingThe health providers will receive the same content of training in eight days, Off-site training, the way it's currently done in Nigeria. Both theoretical and practical through use of manikins - simulation. No reinforcement and further practice will take place once the participants are back in their work stations. Acquisition of knowledge and clinical skills is measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must give informed consent to participate in the study;
- Must have spent at least six months in maternal and/or newborn care services;
- Must be providing services related to maternal and newborn health in selected health facilities at the time of the interview;
- Must be available to participate in the training from the beginning to the end; and
- Must have had pre-service training not incorporating simulation-based LDHF approach from accredited medical schools, schools of nursing/midwifery or health technology.
Key exclusion criteria (3 listed)
- Decides to opt out / declines to participate.
- Has had prior training using the simulation-based LDHF approach.
- Provides services related to maternal and newborn health more than one health facility selected as part of intervention or comparison group.
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 |
|---|---|---|
| Acquisition of Knowledge and clinical skillsLDHF is a novel training approach that is being compared to the traditional training approach | Behavioural | LDHF plus m-Mentoring, Traditional training |
| Onsite trainingParticipants are training at their health facilities | Other | LDHF plus m-Mentoring |
| Off-site trainingParticipants from different health facilities are gathered together in a central location for training, away from their workplaces | Other | Traditional training |
Primary outcome
Percent change in competency in basic obstetric and emergency care between the groups
Time frame: 3 months
Proportion of competent providers who retain clinical competency skills 3 months post-training
3 secondary outcomes
Comparison of retention of skills between the two study arms
Time frame: 12 months
Level of satisfaction of service providers
Time frame: 12 months
Comparison of cost-effectiveness of the two approaches
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Derived from this study: PubMed 32590979Ugwa E, Kabue M, Otolorin E, Yenokyan G, Oniyire A, Orji B, Okoli U, Enne J, Alobo G, Olisaekee G, Oluwatobi A, Oduenyi C, Aledare A, Onwe B, Ishola G. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings among health workers on day of birth care in Nigeria; a cluster randomized controlled trial. BMC Health Serv Res. 2020 Jun 26;20(1):586. doi: 10.1186/s12913-020-05450-9.
- Derived from this study: PubMed 30103761Ugwa E, Otolorin E, Kabue M, Ishola G, Evans C, Oniyire A, Olisaekee G, Onwe B, LeFevre AE, Bluestone J, Orji B, Yenokyan G, Okoli U. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based training approaches on day of birth care among maternal and newborn healthcare providers in Ebonyi and Kogi States, Nigeria; a randomized controlled trial. BMC Health Serv Res. 2018 Aug 13;18(1):630. doi: 10.1186/s12913-018-3405-2.
- Individual participant dataSharing planned: Undecided. The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have access.
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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.
Emmanuel Otolorin principal investigator
Jhpiego
Questions about this trial
What is this clinical trial studying?
A study testing Acquisition of Knowledge and clinical skills, Onsite training and Off-site training in people with Training and Capacity Building, run by Jhpiego.
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 5 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: finished, as of the sponsor's last update on 10 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in competency in basic obstetric and emergency care between the groups (time frame: 3 months). 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 NCT03269240, which also lists 2 linked publications.
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 10 Aug 2018; AzTrials last refreshed its copy on 29 Oct 2026.