Maternal MortalityNCT06134518
Effectiveness of the Education Program on Increasing the Competency Level of Health Cadres in Indonesia
A study testing The education program and the initial orientation from the PHCs in people with Maternal Mortality, run by Hiroshima University at 1 site in Indonesia.
Trial summary
Ending preventable maternal mortality (EPMM): By 2030, every country should reduce its maternal mortality ratio (MMR) by at least two-thirds from the 2010 baseline. In the era of the SDGs, an acceleration of current progress is required to achieve SGD target 3.1, working towards a vision of ending all preventable… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Mortality
- What is being tested?
- The education program and the initial orientation from the PHCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Nov 2023to 17 Feb 2024
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently working as a health care for at least 1 year
- Domiciled in the local area
- Able to operate a telephone
- Those who agreed to give consent and are willing to participate in the study
- Those who agreed to receive the health education program and participate in the whole evaluation process.
Who cannot join
- Those who are planning to move out to another city during the study period.
- Those who are no longer work as a health cadre.
Trial locations and contacts
1 site in 1 country.
About this study
Ending preventable maternal mortality (EPMM): By 2030, every country should reduce its maternal mortality ratio (MMR) by at least two-thirds from the 2010 baseline. In the era of the SDGs, an acceleration of current progress is required to achieve SGD target 3.1, working towards a vision of ending all preventable maternal mortality. In Central Java, one of the most effective efforts to reduce maternal mortality is increasing the number of human resources, who can assist pregnant mothers and supervise their period of pregnancy. The maternal mortality rate (MMR) in Banjarnegara Regency in 2021 is 287.05 per 100,000 live births, this indicates the top 10 in Central Java Province over the past 5 years. Health cadres, who are non-professional volunteer health supporters for pregnant women appointed by regional public health centers (PHCs), are expected to be the key human resources who contribute to reducing MMR in Indonesia and Banjarnegara Regency as well. However, based on an initial study by researchers conducting qualitative research with focus group discussions (FGDs) and in-depth interviews in April-July 2023, researchers found that health cadres had incorrect and unscientific knowledge. Therefore, improving the knowledge and skills of the health cadres through education programs could be expected to further improve the health outcomes of pregnant women, consequently contributing to reducing the MMR.
The purpose of this study is to improve health cadres' competency level in monitoring the risks of pregnant women. This monitoring activities for pregnant women by cadres is an effort to prevent maternal mortality, because if there are complications they can be treated as early as possible.
Read the detailed description
- Prior to the commencement of the study, the PI will visit the selected PHCs as the intervention group and control group, and then explain an overview of this study. The PI obtained the agreement to participate in this study from the head of the PHC.
- The PI will ask the coordinator midwife at each PHC to introduce the names and phone numbers of the health cadres who will be potential participants. The PI and the researchers will contact each potential participant one by one to explain the procedure of this study and then obtain their consent to become a participant in this study. Cadres who belong to PHCs will receive the competency-based education program, and those who belong to PHCs allocated to the control group will follow the initial orientation provided by the PHC.
- The PI and assistant (research team) will create a WhatsApp group for the intervention group and control group, and then distribute the questionnaires at an initial stage. All data will be collected at each PHC where the study will be conducted.
- Conditions
- Maternal Mortality
- Being tested
- The education program, the initial orientation from the PHCs
- Keywords
- competency level, health cadre, maternal mortality
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The education programOther
The intervention group will receive the competency-based education program for 1 month at each PHC, after baseline data collection. The education program will be conducted weekly. This education session will be conducted for 4 hours per session, with 20 health cadres in a group per PHC. The competency level is measured by the researcher developing a competency questionnaire which consists of a knowledge test, skill, and attitude checklist score at the 2nd post-assessment (2 months after being given the education program).
the initial orientation from the PHCsOther
the initial orientation from the PHCs
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The intervention group will receive the competency-based education program for 1 month at each PHC, after baseline data collection. The education program will be conducted weekly. This education session will be conducted for 4 hours per session, with 20 health cadres in a group per PHC .The competency level is measured by the researcher developing a competency questionnaire which consists of a knowledge test, skill, and attitude checklist score at the 2nd post-assessment (2 months after being given the education program). Receives: Other: The education program |
| control | Experimental | Health cadres in the control group have received the initial orientation from the PHCs. In this study, they take only the competency questionnaires including skill check will be collected following the data collection timeline. After completing the research, the control group will receive the education program material used for the intervention group if they require. Receives: Other: the initial orientation from the PHCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The competency level of health cadres
Competency is operationally defined as the ability to integrate components of knowledge, skills, values, and attitudes into practice, and build a trusting relationship with and guide a pregnant woman and her surroundings for them to take evidence-based appropriate behavior. The competency level is measured by the researcher developing a competency questionnaire which consists of a knowledge test, skill, and attitude checklist score
Measured: baseline (T0), after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
Secondary outcomes (5)
The knowledge test scores of health cadres
researcher developing knowledge questionnaire
Measured: baseline (T0), after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The health assessment skills checklist score of health cadres
researcher developing health assessment skills checklist
Measured: after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The communication skills checklist score of health cadres
researcher developing communication skills checklist
Measured: after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The confidence score of health cadres
researcher developing communication skills checklist
Measured: after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The satisfaction score of health cadres
researcher developing satisfaction skills checklist
Measured: after 1 month from the baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Nov 2023
- Primary completion5 Dec 2023
- Study completion17 Feb 2024
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 MortalityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group control group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dewie Sulistyorini, Hiroshima University
- Investigators
- Dewie Sulistyorini, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134518
- Sponsor's protocol ID
- 550/EA/KEPK-FKM/2023
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share according to request to the PI and researcher
Publications
Sulistyorini D, Huq KATME, Babaita AO, Aivey SA, Huiying G, Kazawa K, Fukushima Y, Kako M, Moriyama M. Effectiveness of education programme to increase competency of health cadres in Indonesia: a cluster non-randomised controlled trial. BMJ Open. 2025 Dec 29;15(12):e095428. doi: 10.1136/bmjopen-2024-095428.
PubMed 41469067
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Education Program on Increasing the Competency Level of Health Cadres in Indonesia
- ClinicalTrials.gov ID
- NCT06134518
- Acronym / sponsor ID
- 550/EA/KEPK-FKM/2023
- Conditions
- Maternal Mortality
- Keywords
- competency level, health cadre, maternal mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 18 Nov 2023 (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.
Ending preventable maternal mortality (EPMM): By 2030, every country should reduce its maternal mortality ratio (MMR) by at least two-thirds from the 2010 baseline. In the era of the SDGs, an acceleration of current progress is required to achieve SGD target 3.1, working towards a vision of ending all preventable maternal mortality. In Central Java, one of the most effective efforts to reduce maternal mortality is increasing the number of human resources, who can assist pregnant mothers and supervise their period of pregnancy. The maternal mortality rate (MMR) in Banjarnegara Regency in 2021 is 287.05 per 100,000 live births, this indicates the top 10 in Central Java Province over the past 5 years. Health cadres, who are non-professional volunteer health supporters for pregnant women appointed by regional public health centers (PHCs), are expected to be the key human resources who contribute to reducing MMR in Indonesia and Banjarnegara Regency as well. However, based on an initial study by researchers conducting qualitative research with focus group discussions (FGDs) and in-depth interviews in April-July 2023, researchers found that health cadres had incorrect and unscientific knowledge. Therefore, improving the knowledge and skills of the health cadres through education programs could be expected to further improve the health outcomes of pregnant women, consequently contributing to reducing the MMR.
The purpose of this study is to improve health cadres' competency level in monitoring the risks of pregnant women. This monitoring activities for pregnant women by cadres is an effort to prevent maternal mortality, because if there are complications they can be treated as early as possible.
Detailed description
- Prior to the commencement of the study, the PI will visit the selected PHCs as the intervention group and control group, and then explain an overview of this study. The PI obtained the agreement to participate in this study from the head of the PHC.
- The PI will ask the coordinator midwife at each PHC to introduce the names and phone numbers of the health cadres who will be potential participants. The PI and the researchers will contact each potential participant one by one to explain the procedure of this study and then obtain their consent to become a participant in this study. Cadres who belong to PHCs will receive the competency-based education program, and those who belong to PHCs allocated to the control group will follow the initial orientation provided by the PHC.
- The PI and assistant (research team) will create a WhatsApp group for the intervention group and control group, and then distribute the questionnaires at an initial stage. All data will be collected at each PHC where the study will be conducted.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group control group
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: The education programThe intervention group will receive the competency-based education program for 1 month at each PHC, after baseline data collection. The education program will be conducted weekly. This education session will be conducted for 4 hours per session, with 20 health cadres in a group per PHC .The competency level is measured by the researcher developing a competency questionnaire which consists of a knowledge test, skill, and attitude checklist score at the 2nd post-assessment (2 months after being given the education program). |
| control | Experimental | Other: the initial orientation from the PHCsHealth cadres in the control group have received the initial orientation from the PHCs. In this study, they take only the competency questionnaires including skill check will be collected following the data collection timeline. After completing the research, the control group will receive the education program material used for the intervention group if they require. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently working as a health care for at least 1 year
- Domiciled in the local area
- Able to operate a telephone
- Those who agreed to give consent and are willing to participate in the study
- Those who agreed to receive the health education program and participate in the whole evaluation process.
Key exclusion criteria (2 listed)
- Those who are planning to move out to another city during the study period.
- Those who are no longer work as a health cadre.
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 |
|---|---|---|
| The education programThe intervention group will receive the competency-based education program for 1 month at each PHC, after baseline data collection. The education program will be conducted weekly. This education session will be conducted for 4 hours per session, with 20 health cadres in a group per PHC. The competency level is measured by the researcher developing a competency questionnaire which consists of a knowledge test, skill, and attitude checklist score at the 2nd post-assessment (2 months after being given the education program). | Other | intervention |
| the initial orientation from the PHCsthe initial orientation from the PHCs | Other | control |
Primary outcome
The competency level of health cadres
Time frame: baseline (T0), after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
Competency is operationally defined as the ability to integrate components of knowledge, skills, values, and attitudes into practice, and build a trusting relationship with and guide a pregnant woman and her surroundings for them to take evidence-based appropriate behavior. The competency level is measured by the researcher developing a competency questionnaire which consists of a knowledge test, skill, and attitude checklist score
5 secondary outcomes
The knowledge test scores of health cadres
Time frame: baseline (T0), after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The health assessment skills checklist score of health cadres
Time frame: after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The communication skills checklist score of health cadres
Time frame: after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The confidence score of health cadres
Time frame: after 1 month from the baseline (T1) and after 3 months from the baseline (T2)
The satisfaction score of health cadres
Time frame: after 1 month from the baseline (T1)
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 19 Sep 2024.
- Derived from this study: PubMed 41469067Sulistyorini D, Huq KATME, Babaita AO, Aivey SA, Huiying G, Kazawa K, Fukushima Y, Kako M, Moriyama M. Effectiveness of education programme to increase competency of health cadres in Indonesia: a cluster non-randomised controlled trial. BMJ Open. 2025 Dec 29;15(12):e095428. doi: 10.1136/bmjopen-2024-095428.
- Individual participant dataSharing planned: Yes. Share according to request to the PI and researcher
Related trials for Maternal Mortality
Recruiting
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
Severe Maternal Morbidity, Maternal Death
Recruiting
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Postpartum Complication
Active, not recruiting
Well-Mama Community Doula Navigator Study
Pregnancy Related
Active, not recruitingObservational study
Mortality Outcome of Controlled Hypertension
Hypertension, Morality
Active, not recruiting
Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health
Hypertension in Pregnancy, Hypertension
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.
Dewie Sulistyorini principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The education program and the initial orientation from the PHCs in people with Maternal Mortality, run by Hiroshima University at 1 site in Indonesia.
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 2 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 19 Sep 2024. 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 Indonesia. 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?
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?
The competency level of health cadres (time frame: baseline (T0), after 1 month from the baseline (T1) and after 3 months from the baseline (T2)). 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 NCT06134518, 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 19 Sep 2024.