The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)

Coronary Artery Disease Clinical Trial

— PAPAYA  

Official title:

What Patients Really Want - Patient Preferences Regarding Annual Follow-up After Medical Interventions: The PAPAYA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189070
• Other study ID #: K13-28
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: May 13, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Thorax Centrum Twente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

1. least preferred approach of follow-up

2. the preferred number of follow-up moments per year

3. the from the patients' 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2566
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede

Sponsors (1)

Lead Sponsor	Collaborator
Thorax Centrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of preferred approach for annual follow-up after PCI		1 year	No
Secondary	Least preferred approach for follow up		1 year	No
Secondary	Maximum acceptable number of questions to be answered		1 year	No