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Assessment of patient preference of follow-up in cardiac stent trials


- candidate number18215
- NTR NumberNTR4656
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jun-2014
- Secondary IDsK13-28 METC MST
- Public TitleAssessment of patient preference of follow-up in cardiac stent trials
- Scientific TitlePatient Preference Analysis of Yearly Follow-up After PCI
- ACRONYMPAPAYA Study
- hypothesisTo investigate whether patients prefer to be approached by mailed questionnaires for annual follow-up assessment after PCI procedures versus telephone interviews or email-based follow-up
- Healt Condition(s) or Problem(s) studiedPercutaneous Coronary Intervention (PCI), Patient preference
- Inclusion criteriaAll 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 population), who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012
- Exclusion criteriaPatients who had withdrawn their consent for participation in the TWENTE and DUTCH PEERS trials, respectively.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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 4-jul-2013
- planned closingdate4-jul-2014
- Target number of participants2550
- InterventionsAll subjects will receive a questionnaire with questions regarding their preference with regards of the approach of acquiring follow-up information after PCI.
Patient and procedural characteristics of non-responders were compared to responders.
- Primary outcomeAssessment of preferred approach for annual follow-up after PCI
- Secondary outcome- Least preferred approach for follow up
- Relation between most and least preferred approach of assessment in relation to age, gender, urgency of PCI treatment, history of previous revascularization
- TimepointsQuestionnaires were sent once to the patients home address
- Trial web siteN/A
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESDr. H. Verheij
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C. Birgelen, von
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryRationale:
In current clinical practice there is a increasing demand for real-world evidence to guide public health and clinical decision-making, therefore the patient-centered research approach will be an integral part of future research endeavors. Collaboration between health care workers and patients will thus play an increasing role in future research. To improve this professional relationship it is important to assess patients preferences since patient satisfaction is an important element in evaluating the quality of health care services from the patientís perspective and in predicting how patients will behave after receiving services. Although there are a few patient preference studies on therapy, data is still lacking in how patients prefer to be followed-up There is no data on patients preference on follow-up and how they prefer to be contacted when included in stent trials.

Objective:
To investigate the patient preference of approach to obtain follow-up information after percutaneous coronary intervention (PCI)

Study design:
Single-center, prospective, observational registry

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 population), who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

Intervention:
All subjects will receive a questionnaire with questions regarding their preference with regards of the approach of acquiring follow-up information after PCI

Main study endpoints:
- The primary endpoint is the patient preference on how to be approached for annual follow-up after PCI procedures.
- Secondary endpoints include (1) least preferred approach of follow up, (2) the preferred number of follow-up moments per year, (3) the from the patientís perspective maximum acceptable number of questions to be answered, (4) the assessment of potential relationships between the most and least preferred approach of assessment and patient age, gender, urgency of PCI treatment, and history of previous revascularizations
- Main changes (audit trail)
- RECORD26-jun-2014 - 27-jul-2014


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