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Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework
Sponsor: Anhui Medical University
Summary
The goal of this clinical trial is to evaluate the effectiveness of a shared decision-making (SDM) intervention program based on the Ottawa Decision Support Framework in adult patients with type 2 diabetes (aged ≥18 years, without severe complications). The main questions it aims to answer are: * Does the intervention improve patients' decisional self-efficacy compared to usual care? * Does the intervention enhance patients' actual participation in treatment decision-making? * Does the intervention reduce diabetes-related distress? * Does the intervention improve diabetes self-management behaviors? Researchers will compare the intervention group (receiving the SDM intervention plus usual care) with the control group (receiving usual care only) to see if the intervention leads to significantly better outcomes in decision self-efficacy, decision participation, diabetes distress, and self-management. Participants will: * Receive a Question Prompt List (QPL) handbook and be guided by a nurse to mark their most concerning questions. * Attend face-to-face educational sessions covering disease basics, medication comparisons, lifestyle adjustments, and complication prevention. * Engage in shared decision-making discussions with physicians, nurses, and family members to co-develop a personalized treatment plan. * Complete follow-up assessments at 4 weeks and 6 weeks after discharge via telephone or outpatient visit, including questionnaires on decision participation, self-efficacy, satisfaction, diabetes distress, and self-management behaviors.
Official title: Construction and Preliminary Application of a Shared Decision-Making Intervention Program for Patients With Type 2 Diabetes Based on the Ottawa Decision Support Framework
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-08-27
Completion Date
2026-10-31
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Intervention Group
This intervention is a shared decision-making (SDM) program for adults with type 2 diabetes, guided by the Ottawa Decision Support Framework. It consists of three phases: (1) Assess decision needs - build trust, introduce SDM, distribute a Question Prompt List (QPL) handbook, and let patients mark their top concerns; also collect baseline data using validated scales. (2) Provide decision support - doctors explain current status and treatment options; nurses give education on diet, exercise, medication, and complications; then together with family, patients make a personalized treatment plan. (3) Evaluate outcomes - before discharge, confirm skills and address remaining doubts; follow up at weeks 4 and 6 via phone/clinic to reassess decision self-efficacy, participation, diabetes distress, self-management, and glycemic control. The control group receives usual care only.