Development of an AF Specific Quality of Life Questionnai... | NCT06731543

Studies
Development of an AF Specific Quality of Life Questionnaire: AF-PROMS

NCT06731543

Sponsor

Barts & The London NHS Trust

Status

Completed

Last Update Posted

May 8, 2026Actual

Enrollment

206Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

No interventions will be made

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2014Actual

Primary Completion Date

Oct 18, 2024Actual

Completion Date

Oct 18, 2024Actual

First Submitted Date

Sep 14, 2015

First Submission Date that Met QC Criteria

Dec 9, 2024

First Posted Date

Dec 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 8, 2026Actual

Name	Class
City, University of London	OTHER

Description Module

Brief Summary

This study is aiming to develop a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF).

Detailed Description

This study is aiming to develop and validate a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF). As this questionnaire is currently under development, it is anticipated this measure will be a short questionnaire which will measure various aspects of quality of life. Once the questionnaire has been validated further details of the final metric used and aspects of quality of life covered in the questionnaire can be provided.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

206Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who have atrial fibrillation			Other: No interventions will be made

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No interventions will be made	Other		Patients who have atrial fibrillation

Measure	Description	Time Frame
No primary outcomes will be measured		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with atrial fibrillation (AF)

Exclusion Criteria:

Exclude any participants who it is felt participation will cause distress.
Exclude participants who do not give consent to take part in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with atrial fibrillation (AF)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barts Health NHS Trust		London		EC1A 7BE	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided