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

NCT07785440 | Not Yet Recruiting

• 1 other identifier: 81250921
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Diabetes-related distress

  From enrollment to the end of treatment at 6 weeks.

• Diabetes self-management behaviors

  From enrollment to the end of treatment at 6 weeks.

• Glycemic control

  From enrollment to the end of treatment at 6 weeks.

• Satisfaction with decision-making

  From enrollment to the end of treatment at 6 weeks.

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

OTHER

Other: Intervention Group

Interventions

Intervention Group OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Medical University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lili Chen

CONTACT

+86 13045512663; chen20180524@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: August 27, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share