Qualitative Interviews With Healthcare Professionals

November 8, 2022 updated by: Invibio Ltd

PLANNING PHASE- Qualitative Interviews With Healthcare Professionals to Assist in the Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement (TKR) Surgery for the Treatment of Knee Arthritis.

PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement (TKR) surgery for the treatment of knee arthritis.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The interviews for the SYNC01-PP-USA project will be conducted in person at the American Association of Hip and Knee Surgeons (AAHKS) annual conference in Dallas, Texas, USA during the 3rd, 4th, and 5th November 2022. The interviews will take approximately 30 minutes.

Study Type

Observational

Enrollment (Actual)

6

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

    • Texas
      • Dallas, Texas, United States, 76051
        • AAKHS conference, Dallas

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthcare Professionals attending the AAKHS conference, Dallas during Thursday 3rd to Saturday 5th November 2022.

Description

Inclusion Criteria:

  • Healthcare Professionals who currently care for patients who have undergone Total Knee Replacement surgery.
  • Healthcare Professionals who, in the opinion of the Investigator, can understand the project, co-operate with the interview process and are willing to be interviewed in person.
  • Healthcare Professionals who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.

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: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthcare Professionals
Planning Phase Interviews
Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview
Time Frame: 30 minutes
The interview carried out with the HCPs will ascertain their opinions of the issues that patients report after undergoing TKR. The replies (data) collected could be different for each HCP so there is no outcome measure as such for this data. This information collected will be structured around a set number of questions asked in the interview and will be used to form the potential structure and layout of a Patient Reported Outcome Measure (PROM) and to provide background information for the subsequent Phase One of the project which will take place in the UK.
30 minutes

Collaborators and Investigators

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

Sponsor

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)

November 3, 2022

Primary Completion (Actual)

November 5, 2022

Study Completion (Actual)

November 5, 2022

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SYNC01-PP-USA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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