- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05597046
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
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
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Texas
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Dallas, Texas, United States, 76051
- AAKHS conference, Dallas
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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 |
|---|---|
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Healthcare Professionals
Planning Phase Interviews
|
Interviews
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Interview
Time Frame: 30 minutes
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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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