NCT04439864

Brief Summary

This is a randomized clinical trial evaluating the educational program called My Interventional Drug Eluting Stent Educational App (MyIDEA) that is a pilot at two sites.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

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 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

June 11, 2020

Last Update Submit

June 17, 2020

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • Feasibility of study design engaging elderly patients in novel tablet based education.

    Would research participants enroll and follow up in a study of tablet based education. Do patients think they know everything? Would patients enrolled in the control arm still follow up in the study?

    3 months

Secondary Outcomes (1)

  • Medication adherence

    3 months

Study Arms (2)

MyIDEA

EXPERIMENTAL

Research Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment.

Device: MyIDEA

Treatment as normal

NO INTERVENTION

The research participants were given the chance to play games on the tablet and received normal clinical education.

Interventions

MyIDEADEVICE

An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.

MyIDEA

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • received a drug eluting stent during a Percutaneous Coronary Intervention (PCI) during a hospitalization for the PCI procedure,
  • were greater than 50 years old (funding agency requirement),
  • spoke and understood English.

You may not qualify if:

  • inability to give informed consent
  • allergy to aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Shah V, Dileep A, Dickens C, Groo V, Welland B, Field J, Baumann M, Flores JD, Shroff A, Zhao Z, Yao Y, Wilkie DJ, Boyd AD. Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent. Front Public Health. 2016 Dec 12;4:272. doi: 10.3389/fpubh.2016.00272. eCollection 2016.

    PMID: 28018897BACKGROUND

  • Boyd AD, Moores K, Shah V, Sadhu E, Shroff A, Groo V, Dickens C, Field J, Baumann M, Welland B, Gutowski G, Flores JD Jr, Zhao Z, Bahroos N, Hynes DM, Wilkie DJ. My Interventional Drug-Eluting Stent Educational App (MyIDEA): Patient-Centered Design Methodology. JMIR Mhealth Uhealth. 2015 Jul 2;3(3):e74. doi: 10.2196/mhealth.4021.

    PMID: 26139587RESULT

  • Boyd AD, Ndukwe CI, Dileep A, Everin OF, Yao Y, Welland B, Field J, Baumann M, Flores JD Jr, Shroff A, Groo V, Dickens C, Doukky R, Francis R, Peacock G, Wilkie DJ. Elderly Medication Adherence Intervention Using the My Interventional Drug-Eluting Stent Educational App: Multisite Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Jun 24;8(6):e15900. doi: 10.2196/15900.

    PMID: 32579120DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Andrew D Boyd, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Association Professor

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 19, 2020

Study Start

May 1, 2014

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share