Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases
21 de maio de 2026 atualizado por: Myonghwa Park, Chungnam National University
This study aims to develop and evaluate an online shared decision-making (SDM) educational program for nurses and patients with chronic diseases.
Shared decision-making is a process in which healthcare professionals and patients make health-related decisions together based on the best available evidence and the patient's values and preferences.
The study includes an evaluation phase.
In the evaluation phase, the program will be tested among nurses working in general hospitals and adults with chronic diseases living in the community.
Outcomes related to shared decision-making will be assessed at baseline, immediately after the 4-week program, and 1 month later.
The study is expected to improve shared decision-making competence, experience, and preparedness among both nurses and patients.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
- Comportamental: Online Shared Decision-Making Educational Program for Nurses
- Comportamental: Online Shared Decision-Making Educational Program for Patients With Chronic Diseases
- Comportamental: General Communication Education for Nurses
- Comportamental: General Health Information for Patients With Chronic Diseases
Descrição detalhada
Shared decision-making is a key component of patient-centered care and is particularly important in chronic disease management, where patients often face repeated decisions about treatment options, symptom management, lifestyle modification, and long-term care.
Effective shared decision-making requires healthcare professionals and patients to exchange information, consider available options, and make decisions that reflect both clinical evidence and patient values and preferences.
Nurses play an important role in chronic disease care by providing education, coordinating communication, and supporting patient participation in health-related decision-making.
Patients with chronic diseases also need support to understand their options, clarify their values, and participate actively in decisions about their care.
However, structured educational opportunities to strengthen shared decision-making competence are limited for both nurses and patients.
This study will develop an online shared decision-making educational program for nurses and patients with chronic diseases and will evaluate its effectiveness in two parallel sub-studies.
For nurses, the study will be conducted as a cluster-randomized pretest-posttest controlled trial in general hospitals in Daejeon and Chungcheong-do, Republic of Korea.
Hospitals will serve as clusters, and one hospital will be assigned to the intervention group and the other to the control group by coin toss conducted by a third researcher who is not involved in study implementation or data analysis.
For patients with chronic diseases, the study will be conducted as a cluster-randomized pretest-posttest controlled trial in community health and welfare institutions.
Institutions will serve as clusters and will be assigned in a 1:1 ratio to intervention or control conditions using a computer-generated random allocation sequence prepared by a third researcher not involved in study implementation or data analysis.
The intervention will consist of a 4-week online SDM educational program delivered through a web-based platform.
Nurses in the intervention group will receive an online program consisting of 12 educational videos.
Patients in the intervention group will receive an online program consisting of 5 educational videos.
Control participants will receive comparison materials according to the study protocol.
Outcome measures will be collected at baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment.
The study will evaluate whether the program improves shared decision-making-related competence, experience, knowledge, decisional preparedness, and related outcomes in the two target populations.
Tipo de estudo
Intervencional
Inscrição (Estimado)
288
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.
Contato de estudo
- Nome: Geunyoung Lee
- Número de telefone: +82 42-580-8407
- E-mail: lgy2513@gmail.com
Locais de estudo
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Daejeon, Coréia do Sul, 35015
- Recrutamento
- Chungnam National University
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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
Não
Descrição
Inclusion Criteria for Nurse:
- Registered nurses currently providing direct patient care in participating general hospitals
- Able to understand the purpose and procedures of the study and provide informed consent
- Able to use a computer, tablet, or smartphone to access the online program
Exclusion Criteria for Nurse:
- Not currently engaged in direct patient care
- Unable to clearly express willingness to participate
- Unable to complete the educational program or questionnaires because of technical or language limitations
Inclusion Criteria for Patients:
- Adults aged 19 years or older living in the community
- Diagnosed with one or more chronic diseases requiring ongoing management, including but not limited to hypertension, diabetes mellitus, dyslipidemia, arthritis, chronic respiratory disease, or cardiovascular disease, with at least 3 months elapsed since diagnosis
- Able to understand the purpose and procedures of the study and provide informed consent
- Able to read and respond to survey questions
- Able to use a computer, tablet, or smartphone to access the online program
Exclusion Criteria for Patients:
- Cognitive impairment or communication problems that make participation difficult
- Unable to complete the educational program or questionnaires because of technical or language limitations
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: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Online SDM Educational Program Group
Participants will receive access to a web-based shared decision-making educational program tailored for nurses or patients with chronic diseases for 4 weeks.
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The nurse program is a 4-week web-based shared decision-making educational program for nurses working in general hospitals.
It is designed to enhance nurses' knowledge and skills in shared decision-making, decision support, and patient communication through self-directed online learning.
Comportamental: Online Shared Decision-Making Educational Program for Patients With Chronic Diseases
The patient program is a 4-week web-based shared decision-making educational program for adults with chronic diseases.
It is designed to support patients in participating in shared decision-making by helping them prepare for decisions, explore options, and clarify their values and preferences.
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Comparador Ativo: Control Group
Participants will be provided access to publicly available comparison materials during the 4-week study period.
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The control condition consists of access to publicly available communication-related educational materials, such as those provided by the Nursing Human Resources Employment Education Center.
The control condition consists of access to publicly available health management information, such as that provided by the National Health Information Portal.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in nurses' shared decision-making competence
Prazo: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Nurses' shared decision-making competence will be assessed using a shared decision-making competence scale for nurses.
The scale consists of 26 items with total scores ranging from 26 to 130. Higher scores indicate greater shared decision-making competence.
Changes in scores from baseline to each follow-up assessment will be compared between the intervention and control groups.
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Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Change in patients' shared decision-making experience
Prazo: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Patients' shared decision-making experience will be assessed using the Shared Decision-Making Questionnaire-9 items(SDM-Q-9).
The SDM-Q-9 consists of 9 items, with total raw scores ranging from 0 to 45. Higher scores indicate a greater level of patient-perceived shared decision-making.
Changes in scores from baseline to each follow-up assessment will be compared between the intervention and control groups.
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Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in nurses' shared decision-making experience
Prazo: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Nurses' perceived shared decision-making practice will be assessed using the Shared Decision-Making Questionnaire-Physician version(SDM-Q-Doc).
The SDM-Q-Doc consists of 9 items, with total raw scores ranging from 0 to 45. Higher scores indicate a greater level of clinician-perceived shared decision-making.
Changes in scores across assessment points will be compared between the intervention and control groups.
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Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Change in patients' decisional conflict
Prazo: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Patients' decisional conflict will be assessed using the Decision Conflict Scale(DCS) Korean version.
Scores range from 0 to 100, with higher scores indicating greater decisional conflict.
Therefore, lower scores indicate a better outcome.
Changes in scores across assessment points will be compared between the intervention and control groups.
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Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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Change in shared decision-making knowledge
Prazo: Baseline and immediately after the 4-week intervention
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Shared decision-making knowledge and understanding of the educational content will be assessed using pre- and post-program quizzes developed for each study population.
For nurses, the quiz consists of 24 items, and the number of correct answers will range from 0 to 24.
For patients, the quiz consists of 10 items, and the number of correct answers will range from 0 to 10.
A higher number of correct answers indicates greater knowledge and understanding of the educational content.
Changes in the number of correct answers from baseline to post-intervention will be compared between the intervention and control groups.
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Baseline and immediately after the 4-week intervention
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Preparation for decision making after the intervention
Prazo: Immediately after the 4-week intervention and 1 month after the first post-intervention assessment
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Preparation for decision making will be assessed using the Preparation for Decision Making(PrepDM), including the practitioner version for nurses and the participant version for patients, as applicable.
Scores range from 0 to 100, with higher scores indicating a higher perceived level of preparation for decision making.
Scores will be compared between the intervention and control groups after the intervention and at follow-up.
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Immediately after the 4-week intervention and 1 month after the first post-intervention assessment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Estimado)
10 de maio de 2026
Conclusão Primária (Estimado)
10 de julho de 2026
Conclusão do estudo (Estimado)
3 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
10 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de maio de 2026
Primeira postagem (Real)
15 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202511-SB-236-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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
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