- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07589673
Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases
21 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
288
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Geunyoung Lee
- Telefonnummer: +82 42-580-8407
- E-post: lgy2513@gmail.com
Studieorter
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-
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Daejeon, Sydkorea, 35015
- Rekrytering
- Chungnam National University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in nurses' shared decision-making competence
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in nurses' shared decision-making experience
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
10 maj 2026
Primärt slutförande (Beräknad)
10 juli 2026
Avslutad studie (Beräknad)
3 april 2027
Studieregistreringsdatum
Först inskickad
10 maj 2026
Först inskickad som uppfyllde QC-kriterierna
10 maj 2026
Första postat (Faktisk)
15 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202511-SB-236-01
Plan för individuella deltagardata (IPD)
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NEJ
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