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Determining Effectiveness of Shared decision making in Drug Therapy sElection for Rheumatic Disease – Randomized Controlled Trial

DESCIDE-RD: Determining Effectiveness of Shared decision making in Drug Therapy sElection for Rheumatic Disease – Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011310
Enrollment
300
Registered
2025-12-11
Start date
2025-04-28
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Application of the Shared Decision-Making Model) : In both Study Group 1 and Study Group 2, patients will receive a printed decision aid (DA) that provides self-education on the expected effect

Sponsors

Hanyang University Seoul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A participant is eligible for inclusion in this study if all of the following criteria are met: Signed Written Informed Consent The participant must provide voluntary written consent to participate in the study. Age and Gender The participant must be a male or female aged 19 years or older and under 65 years. Eligibility for Biologic Agents or Small Molecule Inhibitors The participant must meet the reimbursement criteria for biologic agents or small molecule inhibitors. (Refer to the reimbursement criteria.) 1) Rheumatoid Arthritis (RA) The participant must meet both of the following criteria: ? Diagnosis: Diagnosed with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria. ? Disease Activity: DAS28 > 5.1, or DAS28 between 3.2 and 5.1 with radiological evidence of joint damage progression. 2) Ankylosing Spondylitis (AS) The participant must meet all three of the following criteria: ? Diagnosis: Diagnosed with ankylosing spondylitis (AS) according to the 1984 Modified New York Criteria. ? Disease Activity: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) = 4. ? Radiologic and Clinical Criteria: The participant must meet both the radiologic criteria and at least two clinical criteria (including clinical criterion (a)). Radiologic Criteria: Sacroiliitis: Bilateral Grade 2 or higher, or unilateral Grade 3 or 4. Clinical Criteria: (a) Low back pain and stiffness for more than 3 months, improving with exercise but not relieved by rest. (b) Limitation of lumbar spine motion in both the sagittal and frontal planes. (c) Reduced chest expansion.

Exclusion criteria

Exclusion criteria: Participants will be excluded from this study if any of the following criteria apply: 1. Individuals who are unable to voluntarily sign the informed consent form. 2. Individuals who lack access to a compatible device for the ChatBot (e.g., smartphone, tablet, or computer) or do not have the ability or willingness to use the ChatBot. 3. Individuals who are unable to complete study-related assessments.

Design outcomes

Primary

MeasureTime frame
The 9-item Shared Decision-Making Questionnaire (SDM-Q-9)

Secondary

MeasureTime frame
Change in patient satisfaction(DCS);Change in patient satisfaction (EQ-5D);Change in medication adherence(Patient-reported Adherence, MPR);Change in patient's level of empowerment(K-HES);Change in patient's knowledge level(HLIC, DHTL);Change in disease activity(PhyGA, DAS28-ESR/CRP, BASDAI);Leeds Satisfaction Questionnaire

Countries

Korea, Republic of

Contacts

Public ContactSoo-Bin Lee

Hanyang University Seoul Hospital

sb4602@hanyang.ac.kr+82-2-2290-9250

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026