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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clemens von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT02189070
First received: July 11, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: What Patients Really Want - Patient Preferences Regarding Annual Follow-up After Medical Interventions: The PAPAYA Study

Resource links provided by NLM:


Further study details as provided by Thorax Centrum Twente:

Primary Outcome Measures:
  • Assessment of preferred approach for annual follow-up after PCI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Least preferred approach for follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Maximum acceptable number of questions to be answered [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 2566
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Responders
Responding participants
Non-responders
Non-responding participants

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02189070

Locations
Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Sponsors and Collaborators
Thorax Centrum Twente
Investigators
Principal Investigator: Clemens von Birgelen, MD,PhD,Prof Thorax Centrum Twente
  More Information

No publications provided

Responsible Party: Clemens von Birgelen, Professor, Thorax Centrum Twente
ClinicalTrials.gov Identifier: NCT02189070     History of Changes
Other Study ID Numbers: K13-28
Study First Received: July 11, 2014
Last Updated: July 11, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Thorax Centrum Twente:
Follow-up
Percutaneous coronary intervention
Patient preference
DUTCH PEERS
TWENTE

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014