Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework
2026年8月23日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
70
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lili Chen
- 電話番号：+86 13045512663
- メール：chen20180524@163.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：対照群
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他の：介入グループ
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Actual participation in treatment decision-making
時間枠：From enrollment to the end of treatment at 6 weeks
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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.
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From enrollment to the end of treatment at 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diabetes-related distress
時間枠：From enrollment to the end of treatment at 6 weeks.
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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.
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From enrollment to the end of treatment at 6 weeks.
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Diabetes self-management behaviors
時間枠：From enrollment to the end of treatment at 6 weeks.
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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.
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From enrollment to the end of treatment at 6 weeks.
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Glycemic control
時間枠：From enrollment to the end of treatment at 6 weeks.
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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.
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From enrollment to the end of treatment at 6 weeks.
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Satisfaction with decision-making
時間枠：From enrollment to the end of treatment at 6 weeks.
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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.
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From enrollment to the end of treatment at 6 weeks.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月27日
一次修了 (推定)
2026年9月20日
研究の完了 (推定)
2026年10月31日
試験登録日
最初に提出
2026年8月20日
QC基準を満たした最初の提出物
2026年8月23日
最初の投稿 (実際)
2026年8月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月25日
QC基準を満たした最後の更新が送信されました
2026年8月23日
最終確認日
2026年8月1日
詳しくは
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