Qualitative Interviews With Healthcare Professionals

• Sponsor: Invibio Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05597046
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Actual Duration (Days): 2
• Patients Per Site Per Month: 91.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Replacement	Other: Interview

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 Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: 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.
• Actual Study Start Date: Nov 3, 2022
• Actual Primary Completion Date: Nov 5, 2022
• Actual Study Completion Date: Nov 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Healthcare Professionals Planning Phase Interviews	Other: Interview; Interviews

Outcome Measures

Primary Outcome Measures

1. Interview [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AAKHS conference, Dallas	Dallas	Texas	United States	76051

Sponsors and Collaborators

• Invibio Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Invibio Ltd
• ClinicalTrials.gov Identifier: NCT05597046
• Other Study ID Numbers: SYNC01-PP-USA
• First Posted: Oct 27, 2022
• Last Update Posted: Nov 9, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Invibio Ltd: TKR

Study Results

No Results Posted as of Nov 9, 2022