Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases
21 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
288
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Geunyoung Lee
- Número de teléfono: +82 42-580-8407
- Correo electrónico: lgy2513@gmail.com
Ubicaciones de estudio
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Daejeon, Corea del Sur, 35015
- Reclutamiento
- Chungnam National University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in nurses' shared decision-making competence
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in nurses' shared decision-making experience
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de mayo de 2026
Finalización primaria (Estimado)
10 de julio de 2026
Finalización del estudio (Estimado)
3 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202511-SB-236-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .