Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework
2026년 8월 23일 업데이트: Chen Lili, Anhui Medical University
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.
연구 개요
연구 유형
중재적
등록 (추정된)
70
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Lili Chen
- 전화번호: +86 13045512663
- 이메일: chen20180524@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 대조군
|
|
|
다른: 중재 그룹
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Actual participation in treatment decision-making
기간: 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.
|
From enrollment to the end of treatment at 6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diabetes-related distress
기간: From enrollment to the end of treatment at 6 weeks.
|
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
기간: From enrollment to the end of treatment at 6 weeks.
|
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
기간: From enrollment to the end of treatment at 6 weeks.
|
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
기간: From enrollment to the end of treatment at 6 weeks.
|
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.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 27일
기본 완료 (추정된)
2026년 9월 20일
연구 완료 (추정된)
2026년 10월 31일
연구 등록 날짜
최초 제출
2026년 8월 20일
QC 기준을 충족하는 최초 제출
2026년 8월 23일
처음 게시됨 (실제)
2026년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 23일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .