Cardiac ArrhythmiaNCT01672528
Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias
An observational study of Cardiac Arrhythmia, run by Cardiff and Vale University Health Board at 3 sites in United Kingdom.
Trial summary
A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Interview and Questionnaires
- How many people
- 586 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2012to 31 Dec 2019
- 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: Cardiac arrhythmia clinic
Who may be able to join
- Patients with symptomatic cardiac arrhythmias
- Consented to and awaiting a cardiac ablation procedure
- Able to read, write and understand English or Welsh
- Capable of giving informed written consent
Who cannot join
- Not able to read, write and understand English or Welsh
- Not able to provide informed written consent
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospitals Birmingham Foundation Trust
Birmingham, B15 2PR
Cardiff and Vale University Health Board
Cardiff, CF14 7XB
Newcastle Upon Tyne Hospitals NHS Trusts
Newcastle, NE7 7DN
About this study
Official title: A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias
A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias
Read the detailed description
This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research.
Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure.
The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Interview, Questionnaires
- Keywords
- Patient Reported Outcome Measures, PROMs, Cardiac arrhythmia, Cardiac ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Also called Disease specific questionnaire, EQ5D5L
Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire
QuestionnairesOther
Also called Disease specific questionnaire, EQ5D
Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrhythmia patients | Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation. Receives: Other: Interview; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.
Measured: Up to 5 years post ablation
Secondary outcomes (3)
Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?
Measured: Average 10 weeks post ablation
Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?
Measured: Up to 5 years post-ablation.
Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?
Measured: Average 10 weeks post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startOct 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Cardiac ArrhythmiaStudies 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
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- National Institute for Health and Clinical Excellence, University Hospital Birmingham NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University College, London
- Responsible party
- Principal investigator, Dr Grace Carolan-Rees, Cardiff and Vale University Health Board
- Investigators
- Grace Carolan-Rees, PhD, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672528
- Sponsor's protocol ID
- 12-CAD-5351
- Other IDs
- RRK 4429, 6125
- Status last verified
- Jan 2020
- First submitted
- 16 Aug 2012
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Withers KL, Wood KA, Carolan-Rees G, Patrick H, Lencioni M, Griffith M. Living on a knife edge-the daily struggle of coping with symptomatic cardiac arrhythmias. Health Qual Life Outcomes. 2015 Jun 24;13:86. doi: 10.1186/s12955-015-0282-9.
PubMed 26104746
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT01672528
- Acronym / sponsor ID
- 12-CAD-5351
- Conditions
- Cardiac Arrhythmia
- Keywords
- Patient Reported Outcome Measures, PROMs, Cardiac arrhythmia, Cardiac ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- National Institute for Health and Clinical Excellence, University Hospital Birmingham NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University College, London
- Study start
- Oct 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Aug 2012 (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.
A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias
Detailed description
This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research.
Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure.
The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrhythmia patients | – | Other: Interview, Other: QuestionnairesPatients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac arrhythmia clinic
Key inclusion criteria (4 listed)
- Patients with symptomatic cardiac arrhythmias
- Consented to and awaiting a cardiac ablation procedure
- Able to read, write and understand English or Welsh
- Capable of giving informed written consent
Key exclusion criteria (2 listed)
- Not able to read, write and understand English or Welsh
- Not able to provide informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAlso: Disease specific questionnaire, EQ5D5LPatient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire | Other | Cardiac arrhythmia patients |
| QuestionnairesAlso: Disease specific questionnaire, EQ5DPatients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure | Other | Cardiac arrhythmia patients |
Primary outcome
Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
Time frame: Up to 5 years post ablation
This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.
3 secondary outcomes
Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?
Time frame: Average 10 weeks post ablation
Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?
Time frame: Up to 5 years post-ablation.
Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?
Time frame: Average 10 weeks post ablation
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 21 Jan 2020.
- Derived from this study: PubMed 26104746Withers KL, Wood KA, Carolan-Rees G, Patrick H, Lencioni M, Griffith M. Living on a knife edge-the daily struggle of coping with symptomatic cardiac arrhythmias. Health Qual Life Outcomes. 2015 Jun 24;13:86. doi: 10.1186/s12955-015-0282-9.
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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.
Grace Carolan-Rees, PhD principal investigator
Cardiff and Vale University Health Board
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Cardiff and Vale University Health Board at 3 sites in United Kingdom.
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 4 inclusion and 2 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias? (time frame: Up to 5 years post ablation). 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 NCT01672528, 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 21 Jan 2020.