NCT05032495

Brief Summary

In this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. Patient Partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

August 26, 2021

Last Update Submit

April 7, 2024

Conditions

Arrythmia

Keywords

Patient engagement

Outcome Measures

Primary Outcomes (1)

  • Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey

    accept a biological therapy

    2 years

Study Arms (4)

Heart patients who experienced a cardiac arrhythmia while in hospital

Heart patients who experienced a cardiac arrhythmia while in hospital

Other: SurveysOther: Focus group

Heart patients who did not experience a cardiac arrhythmia while in hospital

Heart patients who did not experience a cardiac arrhythmia while in hospital

Other: SurveysOther: Focus group

Heart patients with an upcoming procedure that have not had a cardiac arrhythmia

Heart patients with an upcoming procedure that have not had a cardiac arrhythmia

Other: SurveysOther: Focus group

Members of the general public

Members of the general public

Other: SurveysOther: Focus group

Interventions

SurveysOTHER

Surveys to evaluate prior experience, opinions and intervention acceptability.

Heart patients who did not experience a cardiac arrhythmia while in hospitalHeart patients who experienced a cardiac arrhythmia while in hospitalHeart patients with an upcoming procedure that have not had a cardiac arrhythmiaMembers of the general public
Focus groupOTHER

To answer any questions and discuss topics covered in the standard presentation.

Heart patients who did not experience a cardiac arrhythmia while in hospitalHeart patients who experienced a cardiac arrhythmia while in hospitalHeart patients with an upcoming procedure that have not had a cardiac arrhythmiaMembers of the general public

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from in house databases after confirming patients have agreed to participate in research.

You may qualify if:

  • Upcoming or previous cardiac procedure.

You may not qualify if:

  • Inability to complete an electronic survey or participate in a small group meeting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Insitute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (1)

  • Smith C, Lalu MM, Davis DR. Exploring Patient Viewpoints to Optimize Implementation of a Biological Therapy for Atrial Fibrillation Prevention. CJC Open. 2024 Apr 16;6(7):893-900. doi: 10.1016/j.cjco.2024.04.003. eCollection 2024 Jul.

    PMID: 39026620DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacPatient Participation

Interventions

Surveys and QuestionnairesFocus Groups

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Darryl Davis

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 2, 2021

Study Start

May 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

CA(1)