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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04439864
Other study ID # 2013-0802
Secondary ID P30AG022849UL1TR
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2014
Est. completion date February 28, 2017

Study information

Verified date June 2020
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date February 28, 2017
Est. primary completion date February 28, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
University of Illinois at Chicago John H. Stroger Hospital, National Institute of Nursing Research (NINR), National Institute on Aging (NIA), National Institutes of Health (NIH)

References & Publications (2)

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 Method — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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