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The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients (TheBox)

5. december 2018 opdateret af: RoderickTreskes, Leiden University Medical Center
Study to investigate whether a smart technology intervention can improve clinical and cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial infarction.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
    • Zuid-Holland
      • Leiden, Zuid-Holland, Holland, 2333 ZA
        • Leiden University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: The Box
The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
Ingen indgriben: Control
Patients who are randomized to the control group will receive regular care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Controlled Blood pressure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction of received care
Tidsramme: 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
Tidsramme: One year
Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke
One year
Medication-adherence
Tidsramme: 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
Tidsramme: One year
Measured by the iPAQ questionnaire
One year
Quality of life
Tidsramme: One year
Measured by the validated SF-36 questionnaire
One year
Healthcare utilization
Tidsramme: 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
Tidsramme: One year
One year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Leiden University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. maj 2016

Primær færdiggørelse (Faktiske)

9. november 2018

Studieafslutning (Faktiske)

9. november 2018

Datoer for studieregistrering

Først indsendt

9. august 2016

Først indsendt, der opfyldte QC-kriterier

24. november 2016

Først opslået (Skøn)

29. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P16.070

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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