Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h)

Istituto Ortopedico Rizzoli50 enrolled

Overview

Two methods for detecting outcomes after hip prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (WOMAC 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.

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 hip prosthetic surgery is the WOMAC 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 hip (WOMAC 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 WOMAC Score compared to the two methods and the differences in terms of outpatient assessment times will also be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Quality of Life

Interventions

Extrambulatory digital PROMs detectionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with coxarthrosis 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

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italia, Italy

RECRUITING

Outcomes

Primary Outcomes

Patient's adhesion to the digital 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 WOMAC 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.

Time frame: 1 month before surgery (pre-admission outpatient visit)

Patient's adhesion to the digital compilation one month after surgery

Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC 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.

Time frame: 1 month after surgery (follow up visit)

Patient's adhesion to the digital compilation three months after surgery

Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC 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.

Time frame: 3 months after surgery (follow up visit)

Patient's adhesion to the digital compilation six months after surgery

Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC 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.

Time frame: 6 months after surgery (follow up visit)

Central Contacts

Cesare Stagni, Dr

CONTACT

00393473910599 cesare.stagni@ior.it

Giuseppe Di Sante, Dr

CONTACT

00393286491562 giuseppe.disante@ior.it

Data from ClinicalTrials.gov

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Secondary Outcomes

Level of coherence between the WOMAC score 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 WOMAC 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.

Time frame: 1 month before surgery (pre-admission outpatient visit)

Level of coherence between the WOMAC score 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 WOMAC 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.

Time frame: 1 month after surgery (follow up visit)

Level of coherence between the WOMAC score 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 WOMAC 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.

Time frame: 3 months after surgery (follow up visit)

Level of coherence between the WOMAC score 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 WOMAC 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.

Time frame: 6 months after surgery (follow up visit)