Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework

Construction and Preliminary Application of a Shared Decision-Making Intervention Program for Patients With Type 2 Diabetes Based on the Ottawa Decision Support Framework

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Intervention Group

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lili Chen; Phone Number: +86 13045512663; Email: chen20180524@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Diagnosed with type 2 diabetes mellitus according to the diagnostic criteria established by the Chinese Diabetes Society.
2. Aged 18 years or older.
3. Conscious, able to communicate normally, and capable of reading and completing questionnaires independently or with assistance.
4. Informed consent obtained and voluntary participation.

Exclusion criteria:

1. Complicated with severe acute or chronic complications of diabetes (e.g., diabetic ketoacidosis, severe diabetic nephropathy, proliferative retinopathy, etc.).
2. Complicated with severe heart, liver, kidney, or other organ dysfunction, or malignant tumors.
3. With cognitive impairment, mental disorders, or communication disorders.
4. Currently participating in other interventional clinical studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Other: Intervention Group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actual participation in treatment decision-making	Measured by the Control Preferences Scale (CPS) , originally developed by Lauri et al. and translated into Chinese by Ma Lili (2004). The scale consists of two parts: attitude toward participation in treatment decision-making and actual participation in treatment decision-making. This study uses the part measuring actual participation. The Chinese version has a content validity index of 0.890 and a Cronbach's α coefficient of 0.851 for the actual participation subscale. The 12 items reflect the shared decision-making process: items 1, 6, 7, 8, 9 assess weighing pros and cons; item 5 assesses providing information; items 2, 3, 4 assess expressing preferences; items 10, 11, 12 assess final decision-making. Scoring details follow the standard CPS protocol.	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes-related distress	Diabetes-related distress measured by the Chinese version of the Diabetes Distress Scale (DDS), translated and revised by Yang Qing et al. (2010). The scale contains 17 items across 4 dimensions: emotional burden (5 items: 1,3,8,11,14), physician-related distress (4 items: 2,4,9,15), regimen-related distress (5 items: 5,6,10,12,16), and interpersonal distress (3 items: 7,13,17). Each item uses a 6-point Likert scale (1=no problem, 6=very serious problem). Scoring criteria: mean dimension/item score <2 = no distress, 2-3 = moderate distress, >3 = severe distress. Cronbach's α=0.9515.	From enrollment to the end of treatment at 6 weeks.
Diabetes self-management behaviors	Diabetes self-management behaviors measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale developed by Toobert et al., Chinese version translated by Sun Shengnan et al. The scale contains 13 items across 6 dimensions: general diet (4 items), exercise (2 items), blood glucose monitoring (2 items), foot care (2 items), medication adherence (2 items), and smoking status (1 item). Total score is the sum of all dimension scores, with higher scores indicating better self-management behaviors. Cronbach's α for each dimension ranges from 0.62 to 0.92.	From enrollment to the end of treatment at 6 weeks.
Glycemic control	Glycemic control assessed by two complementary indicators: (1) Fasting blood glucose (FBG, mmol/L) - venous blood samples collected after an 8-hour overnight fast, analyzed using the glucose oxidase method, reflecting short-term glycemic status; (2) Glycosylated hemoglobin (HbA1c, %) - venous blood samples analyzed by high-performance liquid chromatography (HPLC), reflecting average blood glucose levels over the preceding 2-3 months. Lower values of both indicators indicate better glycemic control. According to Chinese Diabetes Society guidelines, target FBG is 4.4-7.0 mmol/L and target HbA1c is <7.0% for most non-pregnant adults with type 2 diabetes.	From enrollment to the end of treatment at 6 weeks.
Satisfaction with decision-making	Decision-making satisfaction measured by the Satisfaction with Decision (SWD) scale adapted by Xu Xiaolin (2010). The scale contains 4 dimensions: information, communication and negotiation, decision-making, satisfaction and confidence. It demonstrates good reliability and validity, with a Cronbach's α coefficient of 0.899. Higher scores indicate greater satisfaction with medical decision-making participation.	From enrollment to the end of treatment at 6 weeks.

Collaborators and Investigators

• Sponsor: Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 27, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: August 20, 2026
• First Submitted That Met QC Criteria: August 23, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 23, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 81250921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No