- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02976376
The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients (TheBox)
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Zuid-Holland
-
Leiden, Zuid-Holland, Nederland, 2333 ZA
- Leiden University Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
Geen tussenkomst: Control
Patients who are randomized to the control group will receive regular care.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Controlled Blood pressure
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Patient satisfaction of received care
Tijdsspanne: 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
Tijdsspanne: One year
|
Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke
|
One year
|
Medication-adherence
Tijdsspanne: 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
Tijdsspanne: One year
|
Measured by the iPAQ questionnaire
|
One year
|
Quality of life
Tijdsspanne: One year
|
Measured by the validated SF-36 questionnaire
|
One year
|
Healthcare utilization
Tijdsspanne: 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
Tijdsspanne: One year
|
One year
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P16.070
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op The Box
-
The Third Xiangya Hospital of Central South UniversityOnbekendBoezemfibrilleren | Atriale remodellering
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)VoltooidHiv | Medicatie therapietrouwIndië
-
Columbia UniversityHelen Hayes HospitalBeëindigd
-
Reproductive Medicine Associates of New JerseyCooperSurgical Inc.WervingOnvruchtbaarheidVerenigde Staten
-
Shandong UniversityVoltooidMagneetgestuurde capsule-endoscopieChina
-
Mid and South Essex NHS Foundation TrustAnglia Ruskin UniversityVoltooid
-
Dr Alison Porter-ArmstrongNorthern Health and Social Care TrustVoltooidHartinfarct | Cerebrovasculair Accident (CVA)Verenigd Koninkrijk
-
University of PennsylvaniaKarolinska University Hospital; Leiden University Medical Center; Vittore Buzzi... en andere medewerkersVoltooidReanimatie | Ademhaling met positieve druk | Neonatale vroeggeboorteVerenigde Staten
-
Kanuni Sultan Suleyman Training and Research HospitalVoltooidTerugkerende zwangerschapsverliezen | Endoplasmatisch reticulumstressKalkoen
-
United States Department of DefenseNational Institute of Mental Health (NIMH)OnbekendFantoompijn in ledematenVerenigde Staten