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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.
Rationale: Assessment and reporting of long-term clinical follow-up after medical interventions is essential for transparency of medical care and its quality improvement. However follow-up adherence is a serious challenge in clinical trials. Taking the patient preference of the mode of follow-up into account is likely to enhance trial adherence, reduce withdrawals, and facilitate a longer follow-up duration. No data on patient preference of annual follow-up have been reported.
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 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 to 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responders | Responding participants | ||
| Non-responders | Non-responding participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of preferred approach for annual follow-up after PCI | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Least preferred approach for follow up | 1 year | |
| Maximum acceptable number of questions to be answered | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Clemens von Birgelen, MD,PhD,Prof | Thorax Centrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26465376 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |