Data AccuracyNCT07509931
Empowerment Training for Personal Agency Development of Primary Health Care Workers
A study testing Empowerment Agency Training (EAT) in people with Data Accuracy and Agency, run by Oxford University Clinical Research Unit Indonesia at 2 sites in Indonesia.
Trial summary
This study evaluates an Empowerment Agency Training (EAT) intervention within the SPHERES programme that aims to strengthen personal agency among workers in primary healthcare centers (Puskesmas) in Indonesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Data Accuracy, Agency, Burnout
- What is being tested?
- Empowerment Agency Training (EAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesIndonesia
- Study dates
- 10 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Registered staff of the intervention clusters (PHCs), either as registered civil servant, contract workers, or honorary workers.
Who cannot join
- PHC staff who decline to provide informed consent.
- PHC staff who will not retain their employment until the end of the observation period.
- Participants who are not in good physical and mental condition to attend the training intervention (for the intervention arm).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites
Lombok Barat District Health Office
Gerung, West Nusa Tenggara
Erni Suryana, B.Sc., M.M,, +62-370-681-430 ext. +62, dinkeslobar@gmail.com
Purbalingga District Health Office
Purbalingga, Central Java
Jusi Febrianto, MPH, MD, +62-815-6704-738 ext. +62, rbdpn2001@yahoo.co.id
About this study
Official title: Strengthening Personal Agency and Service Performance Among Primary Health Care Workers Through a Complex Empowerment Intervention
This study evaluates an Empowerment Agency Training (EAT) intervention within the SPHERES programme that aims to strengthen personal agency among workers in primary healthcare centers (Puskesmas) in Indonesia. The intervention focuses on building self-efficacy, behavioural control, leadership, and intentional decision-making through structured training, follow-up action planning, observational support, and sustainability-oriented incentives. Strengthening personal agency is expected to improve the use of data for decision-making and the delivery of priority primary health services at the Puskesmas level.
Read the detailed description
This study evaluates a complex intervention in the form of an Empowerment Agency Training (EAT) implemented as an integral component of the SPHERES programme (NCT07126041) in Indonesia. The intervention is grounded in the recognition that, within digital health ecosystems, investments in technology and data systems have not consistently translated into improved service delivery due to limited individual capacity, behavioural adaptation, and organisational readiness among health workers. The EAT intervention therefore focuses on strengthening personal agency among Puskesmas staff, defined as the capacity to act intentionally, regulate behaviour, exercise leadership, and make informed decisions in complex work environments.
The EAT intervention comprises four interrelated components delivered in an integrated and adaptive manner. First, empowerment through a personal agency approach is delivered via structured training sessions aimed at strengthening self-awareness, self-efficacy, leadership, assertiveness, and mastery of the work environment. Second, participants develop behaviour-related follow-up action plans that translate personal agency concepts into concrete and achievable changes in daily work practices, including communication, task management, teamwork, and the use of health data for decision-making. Third, expert shadowing provides direct observational support to understand real-world service dynamics. Fourth, sustainability-oriented incentives, including opportunities for advanced training and locally governed financial incentives, are used to reinforce engagement and support longer-term adoption of new practices.
Within the SPHERES programme, the digitalisation of health information systems is deliberately complemented by interventions that address human and organisational factors. By embedding EAT within SPHERES, the intervention is designed to ensure that digital tools and data systems are actively interpreted, used, and translated into service improvements, rather than functioning solely as mechanisms for routine reporting.
The intervention is evaluated using a cluster randomised controlled trial design, in which Puskesmas that are already participating in the SPHERES programme are randomly assigned to receive the additional Empowerment Agency Training (EAT) intervention. The study population includes all staff working at participating Puskesmas, with total population sampling applied at the facility level to ensure comprehensive exposure to the intervention and to minimise contamination. To assess service-related outcomes, selected health service users from Puskesmas catchment areas are also included. Community-level sampling for outcome assessment uses probability-based approaches proportional to population size.
Primary outcomes include clinical data quality, including its completeness and submission timeliness, and changes in personal agency and health worker behaviour, particularly the use of health data for planning and decision-making. Additional outcomes include selected priority health service indicators at the Puskesmas level, such as coverage and quality of maternal, child, and non-communicable disease services. Outcome data are derived from validated personal agency survey instruments administered to health workers, as well as routine service data captured through digital health information systems integrated within the SPHERES platform.
The evaluation adopts a convergent mixed-methods approach. Quantitative data are collected longitudinally before and after intervention implementation to assess changes in outcomes over time. Qualitative data from in-depth interviews, focus group discussions, and field observations are collected in parallel to examine contextual factors influencing implementation, mechanisms of change, acceptability, and sustainability of the intervention. Quantitative and qualitative findings are analysed separately and integrated during interpretation to provide a comprehensive understanding of intervention effects and implementation processes.
At a broader level, this study is designed to generate evidence relevant to national health system development in Indonesia. By evaluating a complex, people-centred intervention embedded within a national digital health transformation programme, the findings are expected to inform policy decisions related to health workforce development, digital health scale-up, and the sustainable integration of system-level interventions into routine primary health care across nuanced settings.
- Conditions
- Data Accuracy, Agency, Burnout, Service Evaluation, Assertiveness
- Being tested
- Empowerment Agency Training (EAT)
- Keywords
- Personal agency, Empowerment training, Primary health care, Health workforce, Behaviour change, Burnout, Data utilisation, Digital health, Health systems, Complex intervention, Randomised controlled trial, Observation, Service delivery improvement, Implementation research, Indonesia
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment Agency Training (EAT)Behavioural
The intervention comprises a behavioral training program focused on personal agency and empowerment. The curriculum follows the established frameworks developed by The Self-Empowerment and Equity for Change (SEE Change) Initiative at the Johns Hopkins Bloomberg School of Public Health. The training is followed by simple, practical "prescription", or action plans, for behaviour change in daily work. Implementation is supported through direct observation by facilitators (expert shadowing) and incentives, including advanced training opportunities and locally managed financial support.
| Study group | Role | What they receive |
|---|---|---|
| Empowerment Training Arm | Experimental | Health care providers in the intervention clusters (PHCs). Receives: Behavioral: Empowerment Agency Training (EAT) |
| Control Arm | No intervention | Health care providers in the non-intervention clusters (PHCs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in clinical data quality between intervention and control arms, and changes in personal agency and health worker behaviour
Clinical data quality is determined by proportion of data entry in the digital health information system compared to the gold standard (legacy reporting system). Other metrics being the heaping index indicating digit preference in numeric clinical data input in various services, and also the proportion of biologically implausible values.
Changes in personal agency and health worker behaviour is determined by the proportion of action derived from data-driven discussion, as well as the overall level of patient satisfaction from the care delivery.
Measured: Up to 6 months
Secondary outcomes (4)
Completeness of care in maternal and neonatal care
- of pregnant women with at least six timely ANC services (K1 - K6)
- of pregnant women with complete services per ANC encounter
- of newborn with at least three timely PNC services (Kn1 - Kn3)
- of mothers with newborn with at least four timely PNC services (Kf1 - Kf4) Neonatal mortality rate Stillbirth rate
All indicators will be measured using the SPHERES dashboard.
Measured: Up to 6 months
Completeness of care in tuberculosis treatment
- of TB suspect screened
- of TB diagnosis from all screened suspects
- of TB patients receiving medications
- of TP patients being loss to follow-up
- of TB patients with complete recovery
All indicators will be measured using the SPHERES dashboard.
Measured: Up to 6 months
Completeness of care in hypertensive treatment
- of people screened for hypertension
- of people with hypertension diagnosis
- of hypertensive patient receiving medications
- of hypertensive patient with controlled blood pressure
All indicators will be measured using the SPHERES dashboard.
Measured: Up to 6 months
Completeness of care in diabetes treatment
- of people screened
- of people with diabetes diagnosis
- of diabetes patient receiving medications
- of people with controlled HbA1c All indicators will be measured using the SPHERES dashboard.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data AccuracyStudies 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
- Sequential
- Model description
- This study employs a cluster randomized trial (CRT) design, nested within the intervention arm of the SPHERES trial. Primary Health Centers (PHCs) previously assigned to the SPHERES intervention arm will undergo a secondary randomisation to be allocated to either the intervention or control group for this nested sub-study. If proven to be efficacious, all SPHERES Puskesmas will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- District Health Office of Purbalingga District, Indonesia, District Health Office of Lombok Barat District, Indonesia, The Self-Empowerment and Equity for Change (SEE Change) Initiative, The United States
- Responsible party
- Principal investigator, Anuraj Shankar, Oxford University Clinical Research Unit Indonesia
- Investigators
- Anuraj H Shankar, D.Sc., Principal investigator, Oxford University Clinical Research Unit Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509931
- Sponsor's protocol ID
- OUCRU-ID.2026.001
- Other IDs
- INV-070822
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will not share individual participant data due to the population-level nature of the intervention and national data privacy regulations. Only aggregated and de-identified/anonymized data and codebook may be made publicly available upon publication. All data collection, storage, and analysis procedures will comply with Indonesia's Personal Data Protection Law (UU PDP), Ministry of Health guidance, and institutional ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Personal Agency and Service Performance Among Primary Health Care Workers Through a Complex Empowerment Intervention
- ClinicalTrials.gov ID
- NCT07509931
- Acronym / sponsor ID
- OUCRU-ID.2026.001
- Conditions
- Data Accuracy, Agency, Burnout, Service Evaluation, Assertiveness
- Keywords
- Personal agency, Empowerment training, Primary health care, Health workforce, Behaviour change, Burnout, Data utilisation, Digital health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oxford University Clinical Research Unit IndonesiaUniversity, hospital or other
- Collaborators
- District Health Office of Purbalingga District, Indonesia, District Health Office of Lombok Barat District, Indonesia, The Self-Empowerment and Equity for Change (SEE Change) Initiative, The United States
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2026 (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.
This study evaluates an Empowerment Agency Training (EAT) intervention within the SPHERES programme that aims to strengthen personal agency among workers in primary healthcare centers (Puskesmas) in Indonesia. The intervention focuses on building self-efficacy, behavioural control, leadership, and intentional decision-making through structured training, follow-up action planning, observational support, and sustainability-oriented incentives. Strengthening personal agency is expected to improve the use of data for decision-making and the delivery of priority primary health services at the Puskesmas level.
Detailed description
This study evaluates a complex intervention in the form of an Empowerment Agency Training (EAT) implemented as an integral component of the SPHERES programme (NCT07126041) in Indonesia. The intervention is grounded in the recognition that, within digital health ecosystems, investments in technology and data systems have not consistently translated into improved service delivery due to limited individual capacity, behavioural adaptation, and organisational readiness among health workers. The EAT intervention therefore focuses on strengthening personal agency among Puskesmas staff, defined as the capacity to act intentionally, regulate behaviour, exercise leadership, and make informed decisions in complex work environments.
The EAT intervention comprises four interrelated components delivered in an integrated and adaptive manner. First, empowerment through a personal agency approach is delivered via structured training sessions aimed at strengthening self-awareness, self-efficacy, leadership, assertiveness, and mastery of the work environment. Second, participants develop behaviour-related follow-up action plans that translate personal agency concepts into concrete and achievable changes in daily work practices, including communication, task management, teamwork, and the use of health data for decision-making. Third, expert shadowing provides direct observational support to understand real-world service dynamics. Fourth, sustainability-oriented incentives, including opportunities for advanced training and locally governed financial incentives, are used to reinforce engagement and support longer-term adoption of new practices.
Within the SPHERES programme, the digitalisation of health information systems is deliberately complemented by interventions that address human and organisational factors. By embedding EAT within SPHERES, the intervention is designed to ensure that digital tools and data systems are actively interpreted, used, and translated into service improvements, rather than functioning solely as mechanisms for routine reporting.
The intervention is evaluated using a cluster randomised controlled trial design, in which Puskesmas that are already participating in the SPHERES programme are randomly assigned to receive the additional Empowerment Agency Training (EAT) intervention. The study population includes all staff working at participating Puskesmas, with total population sampling applied at the facility level to ensure comprehensive exposure to the intervention and to minimise contamination. To assess service-related outcomes, selected health service users from Puskesmas catchment areas are also included. Community-level sampling for outcome assessment uses probability-based approaches proportional to population size.
Primary outcomes include clinical data quality, including its completeness and submission timeliness, and changes in personal agency and health worker behaviour, particularly the use of health data for planning and decision-making. Additional outcomes include selected priority health service indicators at the Puskesmas level, such as coverage and quality of maternal, child, and non-communicable disease services. Outcome data are derived from validated personal agency survey instruments administered to health workers, as well as routine service data captured through digital health information systems integrated within the SPHERES platform.
The evaluation adopts a convergent mixed-methods approach. Quantitative data are collected longitudinally before and after intervention implementation to assess changes in outcomes over time. Qualitative data from in-depth interviews, focus group discussions, and field observations are collected in parallel to examine contextual factors influencing implementation, mechanisms of change, acceptability, and sustainability of the intervention. Quantitative and qualitative findings are analysed separately and integrated during interpretation to provide a comprehensive understanding of intervention effects and implementation processes.
At a broader level, this study is designed to generate evidence relevant to national health system development in Indonesia. By evaluating a complex, people-centred intervention embedded within a national digital health transformation programme, the findings are expected to inform policy decisions related to health workforce development, digital health scale-up, and the sustainable integration of system-level interventions into routine primary health care across nuanced settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a cluster randomized trial (CRT) design, nested within the intervention arm of the SPHERES trial. Primary Health Centers (PHCs) previously assigned to the SPHERES intervention arm will undergo a secondary randomisation to be allocated to either the intervention or control group for this nested sub-study. If proven to be efficacious, all SPHERES Puskesmas will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Empowerment Training Arm | Experimental | Behavioral: Empowerment Agency Training (EAT)Health care providers in the intervention clusters (PHCs). |
| Control Arm | No intervention | –Health care providers in the non-intervention clusters (PHCs). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered staff of the intervention clusters (PHCs), either as registered civil servant, contract workers, or honorary workers.
Key exclusion criteria (3 listed)
- PHC staff who decline to provide informed consent.
- PHC staff who will not retain their employment until the end of the observation period.
- Participants who are not in good physical and mental condition to attend the training intervention (for the intervention arm).
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 |
|---|---|---|
| Empowerment Agency Training (EAT)The intervention comprises a behavioral training program focused on personal agency and empowerment. The curriculum follows the established frameworks developed by The Self-Empowerment and Equity for Change (SEE Change) Initiative at the Johns Hopkins Bloomberg School of Public Health. The training is followed by simple, practical "prescription", or action plans, for behaviour change in daily work. Implementation is supported through direct observation by facilitators (expert shadowing) and incentives, including advanced training opportunities and locally managed financial support. | Behavioural | Empowerment Training Arm |
Primary outcome
Difference in clinical data quality between intervention and control arms, and changes in personal agency and health worker behaviour
Time frame: Up to 6 months
Clinical data quality is determined by proportion of data entry in the digital health information system compared to the gold standard (legacy reporting system). Other metrics being the heaping index indicating digit preference in numeric clinical data input in various services, and also the proportion of biologically implausible values. Changes in personal agency and health worker behaviour is determined by the proportion of action derived from data-driven discussion, as well as the overall level of patient satisfaction from the care delivery.
4 secondary outcomes
Completeness of care in maternal and neonatal care
Time frame: Up to 6 months
Completeness of care in tuberculosis treatment
Time frame: Up to 6 months
Completeness of care in hypertensive treatment
Time frame: Up to 6 months
Completeness of care in diabetes treatment
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. The study will not share individual participant data due to the population-level nature of the intervention and national data privacy regulations. Only aggregated and de-identified/anonymized data and codebook may be made publicly available upon publication. All data collection, storage, and analysis procedures will comply with Indonesia's Personal Data Protection Law (UU PDP), Ministry of Health guidance, and institutional ethical standards.
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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.
Anuraj H Shankar, D.Sc. principal investigator
Oxford University Clinical Research Unit Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Agency Training (EAT) in people with Data Accuracy and Agency, run by Oxford University Clinical Research Unit Indonesia at 2 sites 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 1 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ris HN Sitinjak, M.Sc., Pharm. (+62-813-4777-9810 ext. +62, rsitinjak@oucru.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in clinical data quality between intervention and control arms, and changes in personal agency and health worker behaviour (time frame: Up to 6 months). 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 3 Apr 2026.