- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07690241
Health Informatics Education Effectiveness in Nepal (HI-EDU)
7 de julho de 2026 atualizado por: Dip Bahadur Singh, Axon Infotech Research Academy Pvt. Ltd.
Assessing the Comparative Effectiveness of Health Informatics Education: Knowledge Retention and Technological Awareness in Health Science Students
This study evaluates the effectiveness of a blended Health Informatics (HI) course (HI471) on knowledge retention and technology awareness among health science students in Nepal.
Bachelor of Public Health (BPH) students (intervention group, n=17) received a 14-week HI471 course combining online, virtual, and in-person practical sessions.
A control group of Bachelor of Pharmacy (B.Pharm) students (n=17) continued their standard curriculum without dedicated HI instruction.
Both groups completed a validated 44-item knowledge assessment and an 11-item technology awareness survey at baseline (Week 1) and post-intervention (Week 15).
The primary outcome was the between-group difference in knowledge gain scores.
Results showed that BPH students significantly improved their total knowledge scores (median +31.5 points, r=0.879), while the B.Pharm control group showed no significant change.
BPH students achieved 100% awareness of 9 out of 11 digital health tools at post-test.
This study provides strong evidence that the HI471 blended course is highly effective in building informatics competencies in a low- and middle-income country (LMIC) academic setting.
The study was retrospectively registered.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This controlled pre-test/post-test quasi-experimental study with a non-equivalent control group evaluated the effectiveness of the Health Informatics-471 (HI471) blended course at Madan Bhandari Academy of Health Sciences (MBAHS) in Nepal.
The intervention group (G1) consisted of all 17 Bachelor of Public Health (BPH) students enrolled in the 7th semester, who received the HI471 course.
The control group (G2) consisted of 17 Bachelor of Pharmacy (B.Pharm) 7th-semester students, randomly sampled from 29 eligible students, who received no dedicated HI instruction.
The HI471 course integrated three blended modalities over 14 weeks: (i) online asynchronous LMS instruction (pre-recorded lectures, readings, quizzes), (ii) live synchronous Google Meet sessions, and (iii) in-person practical laboratory sessions covering EHR platforms, DHIS2, SPSS/R, and telemedicine interfaces.
A validated 44-item Health Informatics Knowledge Assessment Tool (with weighted partial-credit scoring, maximum 100 points) and an 11-item binary technology awareness instrument were administered at T1 (Week 1, baseline) and T2 (Week 15, post-intervention).
The primary outcome was the between-group difference in total knowledge gain scores (Δ = T2 - T1), analyzed using non-parametric statistics (Mann-Whitney U, Wilcoxon signed-rank, Friedman, McNemar) with bootstrap effect sizes.
The study demonstrated large, significant knowledge gains in the intervention group (median +31.5 points, r=0.824, p<0.001) compared to the control group, with robust findings across three pre-specified sensitivity analyses.
The intervention group achieved near-complete technology awareness (100% on 9 out of 11 tools).
This research addresses the evidence gap for controlled educational evaluations in low- and middle-income country (LMIC) academic settings.
The study protocol was approved by the MBAHS Institutional Review Committee (IRC-134-082-083), and all participants provided written informed consent.
The study was conducted in compliance with the Declaration of Helsinki (revised 2013).
The study was registered retrospectively.
Tipo de estudo
Intervencional
Inscrição (Real)
34
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Bagmati
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Hetauda, Bagmati, Nepal, 31206
- Madan Bhandari Academy of Health Sciences
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Active enrollment in the 7th semester of the Bachelor of Public Health (BPH) program (intervention group) or the Bachelor of Pharmacy (B.Pharm) program (control group) at Madan Bhandari Academy of Health Sciences (MBAHS).
- Voluntary written informed consent obtained prior to any study procedure.
- Completion of both T1 (Week 1, baseline) and T2 (Week 15, post-intervention) assessments.
Exclusion Criteria:
- Withdrawal from the study before completion of all study procedures.
- Incomplete paired data (missing T1 or T2 assessment).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BPH Intervention Group
Bachelor of Public Health (BPH) 7th-semester students (n=17) who received the 14-week Health Informatics-471 (HI471) blended course, consisting of online asynchronous LMS instruction, live synchronous Google Meet sessions, and in-person practical laboratory work covering seven HI content domains.
|
A 14-week blended educational course combining: (i) online asynchronous LMS instruction (pre-recorded lectures, readings, quizzes); (ii) live synchronous Google Meet sessions (2 hours, 3 days per week); and (iii) in-person practical laboratory sessions (4 hours per week) covering Electronic Health Records (EHR), DHIS2, SPSS/R, and telemedicine interfaces.
No drug, device, biological product, or surgical procedure was involved.
This is a purely educational/behavioral intervention delivered in an academic setting.
|
|
Sem intervenção: B.Pharm Control Group
Bachelor of Pharmacy (B.Pharm) 7th-semester students (n=17) who continued their standard curriculum without any dedicated Health Informatics instruction.
This group served as the non-equivalent control group.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Total Health Informatics Knowledge Score
Prazo: Baseline (Week 1) to post-intervention (Week 15)
|
Measured using the Health Informatics Knowledge Assessment Tool (HIKAT) - a validated 44-item multiple-select instrument with weighted partial-credit scoring.
Scores range from 0 to 100 points, where higher scores indicate better health informatics knowledge.
Administered to both groups at T1 (Week 1, pre-test) and T2 (Week 15, post-test).
The primary causal contrast is the between-group difference in gain scores (Δ = T2 - T1), analyzed using Mann-Whitney U test with bootstrapped effect sizes.
|
Baseline (Week 1) to post-intervention (Week 15)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Domain-Specific Knowledge Gains Across Six HI Content Areas
Prazo: Baseline (Week 1) to post-intervention (Week 15)
|
Change in knowledge scores across six domain areas assessed using the Health Informatics Knowledge Assessment Tool (HIKAT): D1 General HI/Introduction to IT, D2 Operating Systems & Software, D3 Public Health & IT, D4 Database Management, D5+6 Data Analysis & Coding, and D7 Telemedicine.
Each domain score is expressed as a percentage of the domain maximum (minimum: 0%, maximum: 100%), where higher scores indicate greater domain-specific health informatics knowledge.
Domain gains are analyzed using Friedman test with Kendall W and Holm-corrected post-hoc Wilcoxon signed-rank tests within the intervention group.
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Baseline (Week 1) to post-intervention (Week 15)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Technological Awareness Across Digital Health Tools
Prazo: Baseline (Week 1) to post-intervention (Week 15)
|
Change in binary (Yes/No) awareness of 11 digital health tools: EHR, Telemedicine, HMIS, Public Health Informatics, GIS, HIMS, DBMS, Python, Programming Language, Telehealth Platforms, and Remote Patient Monitoring.
|
Baseline (Week 1) to post-intervention (Week 15)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Dip Bahadur Singh, Axon Infotech Research Academy
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de abril de 2026
Conclusão Primária (Real)
20 de junho de 2026
Conclusão do estudo (Real)
30 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de julho de 2026
Primeira postagem (Real)
8 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- HI471-MBAHS-2026
- IRC-134-082-083 (Identificador de registro: Madan Bhandari Academy of Health Sciences IRC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data (IPD) will not be shared because participants did not provide consent for their individual-level data to be shared with external researchers.
Additionally, the small sample size (n=34) increases the risk of participant re-identification, even with de-identification.
All aggregated, anonymized summary data are presented in the published manuscript and supplementary materials
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .