Coronary Artery DiseasePAPAYANCT02189070
The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)
An observational study of Coronary Artery Disease, run by Thorax Centrum Twente at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 2,566 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2013to Sep 2014
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who had withdrawn their consent for participation in the TWENTE and DUTCH PEERS trials, respectively.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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Patients Really Want - Patient Preferences Regarding Annual Follow-up After Medical Interventions: The PAPAYA Study
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.
Read the 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
- least preferred approach of follow-up
- the preferred number of follow-up moments per year
- the from the patients' perspective maximum acceptable number of questions to be answered
- 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
- Conditions
- Coronary Artery Disease
- Keywords
- Follow-up, Percutaneous coronary intervention, Patient preference, DUTCH PEERS, TWENTE
- Medical subject headings
- Coronary Artery Disease, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Responders | Responding participants | |
| Non-responders | Non-responding participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of preferred approach for annual follow-up after PCI
Measured: 1 year
Secondary outcomes (2)
Least preferred approach for follow up
Measured: 1 year
Maximum acceptable number of questions to be answered
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,566 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Thorax Centrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens von Birgelen, Thorax Centrum Twente
- Investigators
- Clemens von Birgelen, MD,PhD,Prof, Principal investigator, Thorax Centrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189070
- Sponsor's protocol ID
- K13-28
- Acronym
- PAPAYA
- Status last verified
- May 2015
- First submitted
- 11 Jul 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26465376
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Patients Really Want - Patient Preferences Regarding Annual Follow-up After Medical Interventions: The PAPAYA Study
- ClinicalTrials.gov ID
- NCT02189070
- Acronym / sponsor ID
- PAPAYA / K13-28
- Conditions
- Coronary Artery Disease
- Keywords
- Follow-up, Percutaneous coronary intervention, Patient preference, DUTCH PEERS, TWENTE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,566 participants (actual)
- Lead sponsor
- Thorax Centrum TwenteUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- least preferred approach of follow-up
- the preferred number of follow-up moments per year
- the from the patients' perspective maximum acceptable number of questions to be answered
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | –Responding participants |
| Non-responders | – | –Non-responding participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of preferred approach for annual follow-up after PCI
Time frame: 1 year
2 secondary outcomes
Least preferred approach for follow up
Time frame: 1 year
Maximum acceptable number of questions to be answered
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Derived from this study: PubMed 26465376Kok 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens von Birgelen, MD,PhD,Prof principal investigator
Thorax Centrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Thorax Centrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of preferred approach for annual follow-up after PCI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.