Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics

Knee Discomfort Clinical Trial

— DIG-PROMs-k  

Official title:

Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto Alla Rilevazione Ambulatoriale Nella Protesica di Ginocchio

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752761
• Other study ID #: CE-AVEC 584/2020 / Oss / IOR
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Giuseppe Di Sante
• Phone: +393286491562
• Email: giusebbeds[@]hotmail.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two methods for detecting outcomes after knee prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (Oxford Knee Score) VS detection using digital questionnaires created on Google Forms and sent to the patient's smartphone on which the compilation takes place in the extra area outpatient.

Description:

PROMs (Patient Reported Outcomes Measures) are used globally for the evaluation of the results of a prosthetic surgery. One of the most used methods in the evaluation of PROMs in knee prosthetic surgery is the Oxford Knee Score, usually measured in an outpatient setting using paper questionnaires.

The aim of the study is to investigate the validity of an alternative method of evaluating PROMs in which the questionnaire will be administered to the patient digitally (Google Forms) in an out-of-patient setting.

The questionnaire aimed at the subjective evaluation of the discomfort induced by arthrosis of the knee (Oxford Knee Score), will be administered during the pre-hospitalization visits and again during the follow-up visits carried out at 1, 3 and 6 months after intervention. The digital evaluation will be sent to the patient during the outpatient visits and will be considered valid only if completed within 48 hours of the same.

On each patient the measurements will be carried out in both methods and differences in terms of compliance and satisfaction with the two methods under examination will be detected. Any differences in the final result of the Oxford Knee Score compared to the two methods and the differences in terms of outpatient assessment times will also be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• patients with gonarthrosis with indication of hip arthroplasty

• males and females aged 18-78 and with a Barthel scale score = 91

• patients in possession of private digital electronic support (smartphone, tablet or PC)

Exclusion criteria:

• patients with a Barthel scale score = 90

• patients with psychiatric pathologies, a history of drug and alcohol abuse

• patients not in possession of private digital electronic support

Related Conditions & MeSH terms

• Approach-Approach Conflict
• Knee Discomfort

Intervention

Behavioral:
• Extrambulatory digital PROMs detection
An alternative PROMs evaluation method will be used in which the questionnaire will be administered to the patient digitally (Google Forms) in an outpatient environment

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's adhesion to the digital Oxford Knee Score compilation after the pre-admission visit	Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one.; Those who complete the questionnaire within 48 hours of the outpatient visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.	1 month before surgery (pre-admission outpatient visit)
Primary	Patient's adhesion to the digital Oxford Knee Score compilation one month after surgery	Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one.; Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.	1 month after surgery (follow up visit)
Primary	Patient's adhesion to the digital Oxford Knee Score compilation three months after surgery	Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one.; Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.	3 months after surgery (follow up visit)
Primary	Patient's adhesion to the digital Oxfor Knee Score compilation six months after surgery	Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the OKS index compared to the conventional one.; Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.	6 months after surgery (follow up visit)
Secondary	Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration one month before surgery	As a secondary end point, the level of coherence between the Oxford Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, one month before surgery, on the occasion of the pre-admission visit.; Which and how many responses will be discordant with respect to the two types of survey will be indicated.	1 month before surgery (pre-admission outpatient visit)
Secondary	Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration one month after surgery	As a secondary end point, the level of coherence between the Oxfor Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, one month after surgery, on the occasion of the follow up visit.; Which and how many responses will be discordant with respect to the two types of survey will be indicated.	1 month after surgery (follow up visit)
Secondary	Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration threee months after surgery	As a secondary end point, the level of coherence between the Oxford Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, three months after surgery, on the occasion of the follow up visit.; Which and how many responses will be discordant with respect to the two types of survey will be indicated.	3 months after surgery (follow up visit)
Secondary	Level of coherence between the OKS detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration six months after surgery	As a secondary end point, the level of coherence between the Oxford Knee Score detected on an outpatient basis by means of a paper questionnaire and that detected by digital extra-ambulatory administration will be examined, six months after surgery, on the occasion of the follow up visit.; Which and how many responses will be discordant with respect to the two types of survey will be indicated.	6 months after surgery (follow up visit)