Patient Engagement Study to Evaluate the Use of Biological Therapies for Cardiac Arrhythmias

Completed

• Conditions: Arrythmia
• Interventions: Other: Surveys; Other: Focus group

• Registration Number: NCT05032495
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Detailed Description

There will be four study groups:

1. Heart patients who experienced a cardiac arrhythmia while in hospital,

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

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

4. Members of the general public.

There will be a presentation, two surveys and a team meeting. Results will be compiled and analyzed.

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-02
• Study Start: 2022-05-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart patients with an upcoming procedure that have not had a cardiac arrhythmia	Surveys	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	Focus group	Heart patients with an upcoming procedure that have not had a cardiac arrhythmia
Heart patients who experienced a cardiac arrhythmia while in hospital	Surveys	Heart patients who experienced a cardiac arrhythmia while in hospital
Heart patients who did not experience a cardiac arrhythmia while in hospital	Surveys	Heart patients who did not experience a cardiac arrhythmia while in hospital
Members of the general public	Surveys	Members of the general public
Members of the general public	Focus group	Members of the general public
Heart patients who experienced a cardiac arrhythmia while in hospital	Focus group	Heart patients who experienced a cardiac arrhythmia while in hospital
Heart patients who did not experience a cardiac arrhythmia while in hospital	Focus group	Heart patients who did not experience a cardiac arrhythmia while in hospital

Primary Outcome Measures

Name	Time	Method
Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey	2 years	accept a biological therapy

Trial Locations

Locations (1)

University of Ottawa Heart Insitute; 🇨🇦 Ottawa, Ontario, Canada