このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

2018年9月6日 更新者:Mintu Turakhia、Stanford University

Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

This study evaluates a smartphone-based cardiac rehabilitation program in adults with coronary artery disease. Half of patients will participate in a smartphone-based cardiac rehabilitation program while the other half will receive standard-of-care.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

Cardiac rehabilitation as a means to improve lifestyle-based risk factor modification, remains poorly prescribed and utilized, often due to the lack of access to programs, poor insurance coverage, cost, or patient or physician motivational factors. Low-cost solutions that can improve patient adherence to medications, risk factor reduction, and exercise could improve cardiovascular outcomes and cost-effectiveness compared to current care models.

研究の種類

介入

入学 (実際)

63

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。

研究場所

    • California
      • Stanford、California、アメリカ、94305
        • Stanford Healthcare

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

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

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: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.
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.
介入なし:Control
Standard-of-care alone.

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.
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.
Baseline through End of Study visit - approximately 90 days per participant.

二次結果の測定

結果測定
メジャーの説明
時間枠
Medication adherence II
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence III
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
The PDC of each medication of the composite
Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence IV
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants with PDC ≥ 80% of each of the composite
Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence V
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Mean time from discharge to first fill
Baseline through End of Study visit - approximately 90 days per participant.
Medication persistence
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors I
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Serum LDL-C at End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors II
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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.
Cardiovascular risk factors III
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors IV
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Change in body weight from baseline to End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors V
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VI
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VII
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
Physical activity at End of Study (measured by a physical acitivity questionnaire)
Baseline through End of Study visit - approximately 90 days per participant.
Exploratory I: Rehospitalization
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
30-day rehospitalization for any reason
Baseline through End of Study visit - approximately 90 days per participant.
Exploratory II: Cardiovascular outcomes
時間枠:Baseline through End of Study visit - approximately 90 days per participant.
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
Baseline through End of Study visit - approximately 90 days per participant.

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

捜査官

  • 主任研究者:Minang (Mintu) Turakhia, MD、Stanford University

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 (実際)

2017年7月19日

一次修了 (実際)

2018年5月9日

研究の完了 (実際)

2018年8月17日

試験登録日

最初に提出

2017年6月16日

QC基準を満たした最初の提出物

2017年6月30日

最初の投稿 (実際)

2017年7月5日

学習記録の更新

投稿された最後の更新 (実際)

2018年9月10日

QC基準を満たした最後の更新が送信されました

2018年9月6日

最終確認日

2018年9月1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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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。

冠動脈疾患の臨床試験

BrightHeart®の臨床試験

類似の治験を検索