NCT02189070

Brief Summary

The purpose of this study is to determine the preference of patients regarding the approach for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that patients prefer questionnaires for annual follow-up assessment when compared to telephone or email.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,566

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

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

July 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

July 11, 2014

Last Update Submit

May 13, 2015

Conditions

Keywords

Follow-upPercutaneous coronary interventionPatient preferenceDUTCH PEERSTWENTE

Outcome Measures

Primary Outcomes (1)

  • Assessment of preferred approach for annual follow-up after PCI

    1 year

Secondary Outcomes (2)

  • Least preferred approach for follow up

    1 year

  • Maximum acceptable number of questions to be answered

    1 year

Study Arms (2)

Responders

Responding participants

Non-responders

Non-responding participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients enrolled in the percutaneous coronary intervention (PCI) studies TWENTE trial (a broad study population reflecting real-world PCI patients) and DUTCH PEERS trial (an all-comers populatoin), who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

You may qualify if:

  • All patients enrolled in the TWENTE trial and DUTCH PEERS trial (an all-comers population, who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

You may not qualify if:

  • Patients who had withdrawn their consent for participation in the TWENTE and DUTCH PEERS trials, respectively. Patients who passed away during follow-up could obviously not be approached for further questioning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, Netherlands

Location

Related Publications (1)

  • Kok MM, von Birgelen C, Lam MK, Lowik MM, van Houwelingen KG, Stoel MG, Louwerenburg JH, de Man FH, Hartmann M, Doggen CJ, van Til JA, IJzerman MJ. Patient preference regarding assessment of clinical follow-up after percutaneous coronary intervention: the PAPAYA study. EuroIntervention. 2016 Apr 20;11(13):1487-94. doi: 10.4244/EIJY15M10_06.

MeSH Terms

Conditions

Coronary Artery DiseasePatient Preference

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Clemens von Birgelen, MD,PhD,Prof

    Thorax Centrum Twente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 14, 2014

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations