Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford Healthcare
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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
説明
Inclusion criteria:
I. ≥ 18 years of age
II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).
III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge
IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan.
V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application.
VIII. Ability to read and understand English.
Exclusion criteria:
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).
II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion.
a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion.
III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease.
V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.
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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:smartphone-based cardiac rehabilitation
The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
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BrightHeart® has two components: smartphone mobile based application and a human coach.
It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
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介入なし:Control
Standard-of-care alone.
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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 |
|---|---|---|
|
Medication adherence
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
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Baseline through End of Study visit - approximately 90 days per participant.
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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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Medication adherence II
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
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Baseline through End of Study visit - approximately 90 days per participant.
|
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Medication adherence III
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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The PDC of each medication of the composite
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Baseline through End of Study visit - approximately 90 days per participant.
|
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Medication adherence IV
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with PDC ≥ 80% of each of the composite
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Baseline through End of Study visit - approximately 90 days per participant.
|
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Medication adherence V
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Mean time from discharge to first fill
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication persistence
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors I
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Serum LDL-C at End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors II
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
|
Baseline through End of Study visit - approximately 90 days per participant.
|
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Cardiovascular risk factors III
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors IV
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Change in body weight from baseline to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
|
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Cardiovascular risk factors V
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors VI
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors VII
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Physical activity at End of Study (measured by a physical acitivity questionnaire)
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Baseline through End of Study visit - approximately 90 days per participant.
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Exploratory I: Rehospitalization
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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30-day rehospitalization for any reason
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Baseline through End of Study visit - approximately 90 days per participant.
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Exploratory II: Cardiovascular outcomes
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days
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Baseline through End of Study visit - approximately 90 days per participant.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Minang (Mintu) Turakhia, MD、Stanford University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- 39555
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?
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米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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