NCT02976376

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

August 9, 2016

Last Update Submit

December 5, 2018

Conditions

Myocardial Infarction

Keywords

Myocardial infarctione-HealthmHealthmobile phonessmartphonefollow-up

Outcome Measures

Primary Outcomes (1)

  • Controlled Blood pressure

    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

Secondary Outcomes (7)

  • Patient satisfaction of received care

    One year

  • Major adverse cardiac events

    One year

  • Medication-adherence

    One year

  • Physical activity

    One year

  • Quality of life

    One year

  • +2 more secondary outcomes

Study Arms (2)

The Box

EXPERIMENTAL

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.

Other: The Box

Control

NO INTERVENTION

Patients who are randomized to the control group will receive regular care.

Interventions

The BoxOTHER

The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.

The Box

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is admitted with acute myocardial infarction
  • Patient is able to communicate in English or Dutch at B1 level

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 35468091DERIVED

  • 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.

    PMID: 32297946DERIVED

  • 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.

    PMID: 28939546DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

August 9, 2016

First Posted

November 29, 2016

Study Start

May 12, 2016

Primary Completion

November 9, 2018

Study Completion

November 9, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

NL(1)