NCT05597046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

2 days

First QC Date

October 25, 2022

Last Update Submit

November 8, 2022

Conditions

Total Knee Replacement

Keywords

TKR

Outcome Measures

Primary Outcomes (1)

  • Interview

    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

Study Arms (1)

Healthcare Professionals

Planning Phase Interviews

Other: Interview

Interventions

InterviewOTHER

Interviews

Healthcare Professionals

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AAKHS conference, Dallas

Dallas, Texas, 76051, United States

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 27, 2022

Study Start

November 3, 2022

Primary Completion

November 5, 2022

Study Completion

November 5, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

US(1)