- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509931
Empowerment Training for Personal Agency Development of Primary Health Care Workers
Strengthening Personal Agency and Service Performance Among Primary Health Care Workers Through a Complex Empowerment Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ris HN Sitinjak, M.Sc., Pharm.
- Phone Number: +62 +62-813-4777-9810
- Email: rsitinjak@oucru.org
Study Contact Backup
- Name: Feliciana Amelinda, MD
- Phone Number: +62 +62-812-8761-589
- Email: famelinda@oucru.org
Study Locations
-
-
Central Java
-
Purbalingga, Central Java, Indonesia
- Purbalingga District Health Office
-
Contact:
- Jusi Febrianto, MPH, MD
- Phone Number: +62 +62-815-6704-738
- Email: rbdpn2001@yahoo.co.id
-
-
West Nusa Tenggara
-
Gerung, West Nusa Tenggara, Indonesia
- Lombok Barat District Health Office
-
Contact:
- Erni Suryana, B.Sc., M.M,
- Phone Number: +62 +62-370-681-430
- Email: dinkeslobar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered staff of the intervention clusters (PHCs), either as registered civil servant, contract workers, or honorary workers.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Empowerment Training Arm
Health care providers in the intervention clusters (PHCs).
|
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.
|
|
No Intervention: Control Arm
Health care providers in the non-intervention clusters (PHCs).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completeness of care in maternal and neonatal care
Time Frame: Up to 6 months
|
All indicators will be measured using the SPHERES dashboard. |
Up to 6 months
|
|
Completeness of care in tuberculosis treatment
Time Frame: Up to 6 months
|
All indicators will be measured using the SPHERES dashboard. |
Up to 6 months
|
|
Completeness of care in hypertensive treatment
Time Frame: Up to 6 months
|
All indicators will be measured using the SPHERES dashboard. |
Up to 6 months
|
|
Completeness of care in diabetes treatment
Time Frame: Up to 6 months
|
|
Up to 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anuraj H Shankar, D.Sc., Oxford University Clinical Research Unit Indonesia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OUCRU-ID.2026.001
- INV-070822 (Other Grant/Funding Number: Gates Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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