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Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases

21 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

288

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Korea Południowa
      • Daejeon, Korea Południowa, 35015
        • Rekrutacyjny
        • Chungnam National University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Online Shared Decision-Making Educational Program for Nurses
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.
Behawioralne: 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.
Aktywny komparator: Control Group
Participants will be provided access to publicly available comparison materials during the 4-week study period.
Behawioralne: General Communication Education for Nurses
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.
Behawioralne: General Health Information for Patients With Chronic Diseases
The control condition consists of access to publicly available health management information, such as that provided by the National Health Information Portal.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in nurses' shared decision-making competence
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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.
Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
Change in patients' shared decision-making experience
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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.
Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in nurses' shared decision-making experience
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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.
Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
Change in patients' decisional conflict
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
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.
Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
Change in shared decision-making knowledge
Ramy czasowe: Baseline and immediately after the 4-week intervention
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.
Baseline and immediately after the 4-week intervention
Preparation for decision making after the intervention
Ramy czasowe: Immediately after the 4-week intervention and 1 month after the first post-intervention assessment
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.
Immediately after the 4-week intervention and 1 month after the first post-intervention assessment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chungnam National University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

10 maja 2026

Zakończenie podstawowe (Szacowany)

10 lipca 2026

Ukończenie studiów (Szacowany)

3 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

10 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 202511-SB-236-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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