Type 2 DiabetesNCT07785440
Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework
A study testing Intervention Group in people with Type 2 Diabetes, run by Anhui Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Being tested
- Intervention Group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Other | Not described Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start27 Aug 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Lili, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785440
- Sponsor's protocol ID
- 81250921
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07785440
- Acronym / sponsor ID
- 81250921
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Other | Other: Intervention Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThis 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. | Other | Intervention Group |
Primary outcome
Actual participation in treatment decision-making
Time frame: From enrollment to the end of treatment at 6 weeks
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.
4 secondary outcomes
Diabetes-related distress
Time frame: From enrollment to the end of treatment at 6 weeks.
Diabetes self-management behaviors
Time frame: From enrollment to the end of treatment at 6 weeks.
Glycemic control
Time frame: From enrollment to the end of treatment at 6 weeks.
Satisfaction with decision-making
Time frame: From enrollment to the end of treatment at 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Type 2 Diabetes, run by Anhui Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Chen (+86 13045512663, chen20180524@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual participation in treatment decision-making (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.