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

April 7, 2024 updated by: Darryl Davis, Ottawa Heart Institute Research Corporation

Patient Directed Strategies for Cardiac Arrhythmia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4W7
        • University of Ottawa Heart Insitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

  • Upcoming or previous cardiac procedure.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart patients who experienced a cardiac arrhythmia while in hospital
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.
Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.
Heart patients who did not experience a cardiac arrhythmia while in hospital
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.
Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.
Heart patients with an upcoming procedure that have not had a cardiac arrhythmia
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.
Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.
Members of the general public
Other: Surveys
Surveys to evaluate prior experience, opinions and intervention acceptability.
Other: Focus group
To answer any questions and discuss topics covered in the standard presentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey
Time Frame: 2 years
accept a biological therapy
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Darryl Davis, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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