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

NCT04749511 | Recruiting

• 1 other identifier: CE-AVEC 583/2020 / Oss / IOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Life

Keywords

PROMs; Digital; Hip prosthesis; WOMAC score

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 months after surgery (follow up visit)

Secondary Outcomes (4)

• 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

  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

  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

  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

  6 months after surgery (follow up visit)

Study Arms (1)

DIG-PROMs-h

OTHER

Patients who underwent THA are given conventional and digital surveys of the WOMAC index. Patients adhesion to both surveys will be compared.

Behavioral: Extrambulatory digital PROMs detection

Interventions

Extrambulatory digital PROMs detection BEHAVIORAL

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.

DIG-PROMs-h

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italia, 40136, Italy

RECRUITING

Central Study Contacts

Cesare Stagni, Dr

CONTACT

00393473910599; cesare.stagni@ior.it

Giuseppe Di Sante, Dr

CONTACT

00393286491562; giuseppe.disante@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: February 11, 2021
• Study Start: November 30, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)