治験レーダーAI | ||
|---|---|---|
治験 NCT06150508（対象：高血圧、糖尿病）は状況不明です。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。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
検索に戻る
ソウル大学校Randomized Controlled Trial of the Smart O2O Model Development for Chronic Diseases Management Through Digital Health 1,000 無作為化 デジタルヘルス 生活習慣
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 NCT06150508 は 介入研究 臨床試験 で、高血圧、糖尿病 に関するものです。現在は 状況不明 で、2023年11月1日 から開始しています。1,000 名の参加者 の募集が計画されています。この試験は ソウル大学校 によって主導され、2024年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2023年11月29日 です。
概要
Objectives The aim of this intervention is to assess how well and how efficiently the O2O Service Model works in delivering primary healthcare and managing chronic diseases for patients living in Pyeongchang-gun at the local government level.
Trial design This is a randomized controlled trial with restricted, batch, blocked and individual random assignment. Investigators will allocate 1,000 participants from Pyeongc...
もっと見る詳細説明
Objectives The objective of this intervention is to evaluate the effectiveness and efficiency of the Online-to-Offline(O2O) Service Model developed to provide primary healthcare and management of chronic diseases targeting patients residing in Pyeongchang-gun at the local government level.
The randomized controlled trial of this intervention will help verifying the model, and provide valuable information about the e...
もっと見る公式タイトル
Randomized Controlled Trial of the Smart Online-to-Offline Model Development for Chronic Diseases Management Through Digital Health in Real World Setting
疾患名
高血圧糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- IRB No: 2308-183-1463
主目的
医療サービス研究
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
非介入Comparative group Comparators will not be provided with the O2O service, but will be treated as usual (TAU) through the 1st tier health care clinics/centers in Pyeongchang-gun county. | 該当なし |
実験的Intervention group Intervention group will use the service app "Value Health" for life-log recording. They regularly record life-log data such as blood pressure, blood glucose, medication, diet, exercise, and weight. (As mentioned, glucose level and blood pressure measurements will be automatically shared with the app using Bluetooth function of the provided checkers.) Interventions through application include automated message and ala...もっと見る | O2O digital healthcare service The O2O service includes a mobile app and web-based portal that allows patients to monitor their blood glucose levels, track their medication use and physical activity, receive personalized feedback and education, and communicate with healthcare providers. The treatment group will receive a blood sugar checker and blood pressure checker that send the records automatically to the application through Bluetooth. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Blood pressure | Diastolic blood pressure, Systolic blood pressure (mmHg) | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Fasting blood glucose level (FBG) in mg/dL | Glucose level | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Glucose level | HbA1c in percent | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Lipid profile | Cholesterol, Triglyceride(TG), HDL Cholesterol, LDL Cholesterol(All in ㎎/㎗) | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Body measurement | Weight in kilogram, height in meters, BMI kg/m\^2 | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Waist circumference in centimeter | Body measurement | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Medication Adherence | Duration of Medication Use/Prescription Period | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Costs of treatment (Healthcare expenditure) | Healthcare expenditure related to manage the designated disease | up to 6 months after for hypertension patient or 9 months after for diabetes patient |
Lifestyle questionnaire | We use questionnaire for assessing physical activity, smoking status and alcohol drinking. This questionnaire is based on Health checkup questionnaire for general health screening in Korea and Guideline for Primary Health Care Chronic Diseases Management Pilot Program(3rd Revision) in Korea. "In relation to physical activity, the assessment will include regular exercise habits, types of exercise, intensity of exercise, and the amount of exercise. Regarding alcohol consumption, current drinking status and drinking history will be evaluated. For smoking, lifelong smoking status, as well as current and past smoking history, will be confirmed. | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Participation aged 18 to 70 years
- Participation diagnosed with diabetes (including borderline diabetes) or hypertension (including borderline hypertension)
However, we will exercise flexibility in age eligibility, allowing patients above 70 years to participate if they meet the following criteria:
Digital Literacy: Participants above 70 years must demonstrate proficiency in digital technology and the ability to effectively use the mobile application "Value Health," which has been specially developed for this research.
- Incompatible Mobile Device: Individuals using older mobile phones that are not compatible with the "Value of Health" application will be excluded.
- Participation in Concurrent Research: Individuals who are currently participating in another research program involving smart health technology will not be eligible for inclusion in our study.
- Non-Acceptance of Random Assignment or Participation: Individuals who do not agree to be randomly assigned to either the treatment or control group or who do not wish to engage in our research program will be excluded from participation.
ソウル大学校377 件のアクティブな治験を探索- Korea Health Industry Development Institute
- ソウル大学校377 件のアクティブな治験を探索
試験中央連絡先
連絡先: Juho Choi, MD, 01072797401, [email protected]
連絡先: Hee Jung Lee, BS, 01024687863, [email protected]
位置情報がありません。