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治験 NCT06807827 (COGNIPHARM-II)（対象：糖尿病）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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Pharmacist-Led Cognitive Behavioral Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life (COGNIPHARM-II) 385 無作為化
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06807827 (COGNIPHARM-II) は 介入研究 臨床試験 で、糖尿病 に関するものです。現在は 募集準備中 で、2025年2月20日 に開始予定です。385 名の参加者 の募集が計画されています。この試験は Hamdard University によって主導され、2025年8月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年2月4日 です。
概要
This interventional study will to assess the impact of pharmacist-led educational intervention along with cognitive behavioral intervention in diabetic patients. Participants of this study will be provided regular counselling or cognitive behavioral intervention and educational material as part of their routine pharmacy visit. Researchers will compare the two groups to see which of the two groups improve in term of m...もっと見る
詳細説明
The purpose of the study is to investigate whether incorporating pharmacist-led educational interventions along with Cognitive Behavioral Therapy (CBT) can result in better outcomes for diabetic patients. Effective diabetes management requires proper education and adherence to medication. Missed doses or irregular medication use can lead to poor glycemic control and increased complications. The study will examine if ...もっと見る
公式タイトル
Pharmacist-Led Educational Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life
疾患名
糖尿病その他の研究識別子
- COGNIPHARM-II
- MU0624-IF
NCT番号
開始日
2025-02-20
最終更新日
2025-02-04
終了予定日
2025-08-31
目標参加者数
385
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Educational Intervention
Cognitive behavioral therapy
Pharmacist
Medication Adherence
Quality of life
Cognitive behavioral therapy
Pharmacist
Medication Adherence
Quality of life
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Control Group Routine healthcare practices and protocols for diabetes management. Regular advice on medication, diet, and lifestyle modifications in accordance with established guidelines, Follows conventional approaches. Lifestyle Modification(Provide guidance on how to maintain a healthy lifestyle, including balanced diet, exercise and regular sleep patterns). General Knowledge advancement. General knowledge about disease and me...もっと見る | Basic Education Basic Education about lifestyle Modification(Provide guidance on how to maintain a healthy lifestyle, including balanced diet, exercise and regular sleep patterns). General Knowledge advancement. General knowledge about disease and medicine. Pill planner will be provided to keep them adherent to their medication. General Medication counselling. |
実験的Cognitive Behavioral Interventional Group Specific Patient-centered strategies beyond routine care designed to address individualized needs. Customized interventions, including pharmacist-led educational sessions, personalized counseling, or advanced lifestyle modifications. Aims to enhance patient outcomes by providing tailored and innovative solutions for better diabetes management.
Change in lifestyle / link with any daily activity (Yoga and Meditation S...もっと見る | Pharmacist-led Cognitive Behavioral therapy Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effec...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Medication adherence score | Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.
This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence \<6 is poor adherence, and \>8 is high adherence. | 3 months |
Quality of life Score | Patient's quality of life will be assessed using Revised Version of DQOL (RV-DQOL13 ; Audit of diabetes dependent quality of life) will be used to access the quality of life of the patient. Its scoring ranges from 1- 100 | 3 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Drug-Drug Interactions | Drug interactions among oral anti glycemic and other drugs will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervention in both control and Cognitive Behavioral Intervention groups. | 3 months |
HbA1c % | HbA1c levels (%) will be assessed before the intervention is provided and after 3 months. | 3 months |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
25 Years
対象性別
全て
All confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration.
Patients having HbA1c >8%. Follow up as well as new patients were included subjects willing to participate in the study with or without other severe co-morbidities were included in the study.
GDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c <8% Patient who are not interested in the study are excluded.
Hamdard University責任者
Matti Ullah, 主任研究者, Assistant Professor, Hamdard University
試験中央連絡先
連絡先: Matti Ullah, Ph.D Clinical Research, +92-331-5056501, [email protected]
連絡先: Iqra Farooq, M.Phil Pharmacy Practice
1 1カ国の場所
ICT
Shifa International Hospital, Islamabad, ICT, 44000, Pakistan
Iqra Farooq, Mphil Pharmacy Practice, 連絡先, 03335644661, [email protected]
Sara Ghulam Yahya, Ms Health Care Management, 連絡先, [email protected]