Medication AdherenceNCT04439864
Perspectives Patient Education Randomized Study
A study testing MyIDEA in people with Medication Adherence, run by University of Illinois Chicago.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- MyIDEA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- inability to give informed consent
- allergy to aspirin
About this study
Official title: 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.
- Conditions
- Medication Adherence
- Being tested
- MyIDEA
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyIDEADevice
An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.
| Study group | Role | What they receive |
|---|---|---|
| MyIDEA | Experimental | Research Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 May 2014
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Cook County Health, National Institutes of Health (NIH), National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Andrew D Boyd, University of Illinois Chicago
- Investigators
- Andrew D Boyd, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439864
- Sponsor's protocol ID
- 2013-0802
- Other IDs
- P30AG022849, UL1TR000050, P30NR010680
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28018897Boyd 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.
PubMed 26139587Boyd 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.
PubMed 32579120
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives Post Percutaneous Coronary Intervention Randomized Study
- ClinicalTrials.gov ID
- NCT04439864
- Acronym / sponsor ID
- 2013-0802
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Cook County Health, National Institutes of Health (NIH), National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyIDEA | Experimental | Device: MyIDEAResearch Participants interacted with MyIDEA program both in the hospital and in the follow up cardiology appointment. |
| Treatment as normal | No intervention | –The research participants were given the chance to play games on the tablet and received normal clinical education. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- inability to give informed consent
- allergy to aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyIDEAAn educational tablet app that is customized to the patient based on the data in the Electronic Health Record. | Device | MyIDEA |
Primary outcome
Feasibility of study design engaging elderly patients in novel tablet based education.
Time frame: 3 months
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?
1 secondary outcome
Medication adherence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Background: PubMed 28018897Shah 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.
- Results publication: PubMed 26139587Boyd 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.
- Derived from this study: PubMed 32579120Boyd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Boyd, MD principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing MyIDEA in people with Medication Adherence, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study design engaging elderly patients in novel tablet based education. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439864, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.