Diabetes Distress, Medication Adherence Barriers, Self-Management, and Glycemic Control in Adults With Type 2 Diabetes
The Mediating Role of Diabetes Self-Management in the Relationship Between Diabetes Distress, Medication Adherence Barriers, and Glycemic Control Among Patients With Type 2 Diabetes
This observational study will examine the relationships among diabetes distress, practical barriers to medication use, diabetes self-management, and glycemic control in adults with type 2 diabetes. Participants who meet the study criteria and agree to take part will complete questionnaires about their personal and clinical characteristics, diabetes distress, medication-taking barriers, and diabetes self-management. With their permission, the most recent HbA1c result measured within the previous three months will be obtained from their medical record. No treatment or medication changes will be made for this study. The researchers plan to include at least 137 participants.
調査の概要
状態
条件
詳細な説明
This single-center, cross-sectional observational study will be conducted at the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye. The study will examine whether diabetes self-management statistically mediates the relationships between diabetes distress and glycemic control, and between practical medication adherence barriers and glycemic control, as measured by HbA1c.
Adults aged 18 years or older with a diagnosis of type 2 diabetes for at least six months, receiving oral antidiabetic medication and/or insulin, and with an HbA1c result measured within the previous three months will be eligible. Participants must be able to communicate in Turkish and provide informed consent. Individuals with type 1 or gestational diabetes, those unable to complete the questionnaires because of cognitive or other serious communication difficulties, and those without a recent HbA1c result will be excluded.
Data will be collected once through a personal information form, the Diabetes Distress Scale, the Medication Practical Barriers to Adherence Questionnaire, and the Type 2 Diabetes Self-Management Scale. The most recent HbA1c result will be obtained from the participant's medical record or hospital information system with permission. Completing the study forms is expected to take approximately 15-20 minutes. No intervention will be provided, and participants' usual care will not be changed. The planned sample size is at least 137 participants.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Burcu Bayrak Kahraman, PhD
- 電話番号：+905057542411
- メール：burcu.bayrak@bilecik.edu.tr
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults with type 2 diabetes mellitus who attend the Diabetes Nursing Unit of Bozüyük State Hospital in Bilecik, Türkiye, have had type 2 diabetes for at least six months, and meet the study eligibility criteria.
説明
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus for at least six months.
- Attending the Diabetes Nursing Unit.
- Using oral antidiabetic medication and/or insulin.
- Having an HbA1c result measured within the previous three months.
- Able to communicate in Turkish.
- Voluntarily agrees to participate in the study.
Exclusion Criteria:
- Diagnosis of type 1 diabetes mellitus or gestational diabetes.
- No HbA1c result measured within the previous three months, or the result is unavailable.
- Withdraws from the study.
- Study forms are substantially incomplete.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Adults With Type 2 Diabetes Mellitus
Adults aged 18 years or older with type 2 diabetes for at least 6 months who meet the study eligibility criteria. All participants will be assessed in a single group. |
Diabetes distress will be assessed once using the 17-item Diabetes Distress Scale (DDS). No intervention will be assigned, and participants' usual diabetes care will not be changed. Practical barriers to medication adherence will be assessed once using the 15-item Medication Practical Barriers to Adherence Questionnaire. No intervention will be assigned, and participants' usual diabetes care will not be changed. Diabetes self-management will be assessed once using the 19-item Type 2 Diabetes Self-Management Scale. No intervention will be assigned, and participants' usual diabetes care will not be changed. |
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 |
|---|---|---|
|
Glycemic control measured by glycated hemoglobin (HbA1c)
時間枠：At study enrollment; the most recent HbA1c result measured within the previous 3 months.
|
The primary outcome is glycemic control, assessed by the most recent HbA1c result recorded within 3 months before enrollment. With permission, HbA1c will be obtained from the participant's medical record or hospital information system. Cross-sectional associations of HbA1c with diabetes distress and medication adherence barriers, and the statistical mediating role of diabetes self-management in these relationships, will be examined. |
At study enrollment; the most recent HbA1c result measured within the previous 3 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean score on the 17-item Diabetes Distress Scale
時間枠：Once at study enrollment.
|
Diabetes distress will be measured using the 17-item Diabetes Distress Scale (DDS). Each item is rated from 1 to 6, and the overall score is calculated as the mean of the 17 item scores, resulting in a score range of 1 to 6. Higher scores indicate greater diabetes distress (a worse outcome). The score will be analyzed in relation to HbA1c and diabetes self-management. |
Once at study enrollment.
|
|
Total score on the Medication Practical Barriers to Adherence Questionnaire
時間枠：Once at study enrollment
|
Practical barriers to medication adherence will be assessed using the 15-item Medication Practical Barriers to Adherence Questionnaire (MPRAQ). Each item is rated on a 5-point Likert scale. The total score ranges from 15 (minimum) to 75 (maximum). Higher scores indicate greater practical barriers to medication adherence (a worse outcome). The score will be analyzed in relation to HbA1c and diabetes self-management. |
Once at study enrollment
|
|
Diabetes self-management score
時間枠：Once at study enrollment
|
Diabetes self-management will be assessed using the 19-item Type 2 Diabetes Self-Management Scale. Its statistical mediating role in the relationships of diabetes distress and medication adherence barriers with HbA1c will be examined. |
Once at study enrollment
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- T2DM-DSM-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
No individual participant data (IPD) will be shared with other researchers. The study protocol does not include an IPD-sharing plan. Participant confidentiality will be protected, and only aggregate study findings may be reported in publications.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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