Perspectives Patient Education Randomized Study

Perspectives Post Percutaneous Coronary Intervention Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Device: MyIDEA

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. inability to give informed consent
2. allergy to aspirin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyIDEA; Research Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment.	Device: MyIDEA; An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.
No Intervention: Treatment as normal; The research participants were given the chance to play games on the tablet and received normal clinical education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	A measure of Pharmacy days covered for DAPT medication. The patients after recieving a Drug Eluting Stent need to adhere to Dual Antiplatlet Therapy (DAPT) to prevent restenosis of the stent. PDC is a calculation of the DAPT which is Aspirin and an ADP receptor antagonist. As aspirin is over the counter, the pharmacy does not have a record of purchase so the PDC was calculated for the ADP receptor antagonis.	3 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH); National Institute on Aging (NIA); John H. Stroger Hospital
• Investigators: Principal Investigator: Andrew D Boyd, MD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2013-0802; P30AG022849 (U.S. NIH Grant/Contract); UL1TR000050 (U.S. NIH Grant/Contract); P30NR010680 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No