The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients (TheBox)
調査の概要
詳細な説明
Rationale: Smart technology could improve quality of care in patients after acute myocardial infarction (AMI) with either ST or non-ST elevation.
Objective: The objective of this study is to measure the effect of a smart technology intervention on patients after AMI.
Study design: The design of the study is a single-center, open randomized-controlled trial.
Study population: The study population consists of patients who have been discharged from the ward of the cardiology department of the Leiden University Medical Center after primary percutaneous coronary intervention (PCI) for either ST or non-ST elevation myocardial infarction.
Intervention: Patients will be randomized to either "The Box" or regular follow-up. Patients who have been randomized to The Box will receive a box containing a smartphone compatible electrocardiogram (ECG) monitor, a weight scale, an activity tracker and a blood pressure monitor. If patients are randomized to The Box, two of the four outpatient clinic visits will be replaced by an e-consult, in which a patient does not have to go to the hospital, but talks with his or her doctor or nurse practitioner via a secured video connection.
Main study parameters/endpoints: The primary endpoint of the study will be the percentage of patients with controlled blood pressure in both groups.
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
-
-
Zuid-Holland
-
Leiden、Zuid-Holland、オランダ、2333 ZA
- Leiden University Medical Center
-
-
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:
- Patient is admitted with acute myocardial infarction
- Patient is able to communicate in English or Dutch at B1 level
Exclusion Criteria:
- Body Mass Index > 35 kg x m-2
- Included in another randomized controlled trial
- Patient is <18 years of age
- Patient is considered an incapacitated adult
- Patient is pregnant
- Patient is unwilling to sign the informed consent form
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：The Box
After randomization, patients in the intervention group will receive a box ("The Box") with all the devices described above.
Instructions about the installation and usage of the devices will be given.
Patients will be asked to measure their weight and blood pressure once a day.
Furthermore, patients will be asked to record an ECG using the AliveCor once a day.
Moreover, they are asked to record an ECG in case of any symptoms of possible cardiac origin, as judged by the patient.
All data will be automatically transferred to the Leiden University Medical Center.
Lastly, two of the four outpatient clinical visits will be done via a video connection.
The content of the interview will be comparable to the content of a regular outpatient clinic visit.
|
The Box contains four smartphone compatible devices.
Patients will measure their vital signs and automatically send them to the hospital.
|
|
介入なし：Control
Patients who are randomized to the control group will receive regular care.
|
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 |
|---|---|---|
|
Controlled Blood pressure
時間枠：One year
|
A blood pressure is considered controlled if the average of three measurements is below 140 (systolic) and 90 (diastolic) after 12 months of follow-up
|
One year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient satisfaction of received care
時間枠：One year
|
Patient satisfaction, defined as the hight of scores derived from validated patient satisfaction questionnaire, will be measured in both groups.
|
One year
|
|
Major adverse cardiac events
時間枠：One year
|
Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke
|
One year
|
|
Medication-adherence
時間枠：One year
|
Medication adherence is measured by validated medication adherence questionnaires.
This questionnaires asks if patients take their medicines in accordance to doctors advice.
|
One year
|
|
Physical activity
時間枠：One year
|
Measured by the iPAQ questionnaire
|
One year
|
|
Quality of life
時間枠：One year
|
Measured by the validated SF-36 questionnaire
|
One year
|
|
Healthcare utilization
時間枠：One year
|
Defined as the number of hospital visits, defined as an outpatient clinic visit, emergency care visit or admission for any reason.
This will be measured via questionnaires and verified by EMR data
|
One year
|
|
Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected
時間枠：One year
|
One year
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Treskes RW, van den Akker-van Marle ME, van Winden L, van Keulen N, van der Velde ET, Beeres S, Atsma D, Schalij MJ. The Box-eHealth in the Outpatient Clinic Follow-up of Patients With Acute Myocardial Infarction: Cost-Utility Analysis. J Med Internet Res. 2022 Apr 25;24(4):e30236. doi: 10.2196/30236.
- Treskes RW, van Winden LAM, van Keulen N, van der Velde ET, Beeres SLMA, Atsma DE, Schalij MJ. Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e202165. doi: 10.1001/jamanetworkopen.2020.2165.
- Treskes RW, van Winden LA, van Keulen N, Atsma DE, van der Velde ET, van den Akker-van Marle E, Mertens B, Schalij MJ. Using Smart Technology to Improve Outcomes in Myocardial Infarction Patients: Rationale and Design of a Protocol for a Randomized Controlled Trial, The Box. JMIR Res Protoc. 2017 Sep 22;6(9):e186. doi: 10.2196/resprot.8038.
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 (見積もり)
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
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。