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

NCT ID: NCT04749511

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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DIG-PROMs-h

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

Group Type OTHER

Extrambulatory digital PROMs detection

Intervention Type 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.

Interventions

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Extrambulatory digital PROMs detection

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Ortopedico Rizzoli

Bologna, Italia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Cesare Stagni, Dr

Role: CONTACT

00393473910599

Giuseppe Di Sante, Dr

Role: CONTACT

00393286491562

Facility Contacts

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Cesare Stagni, Dr

Role: primary

00393473910599

giuseppe di sante, Dr

Role: backup

00393286491562

Other Identifiers

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CE-AVEC 583/2020 / Oss / IOR

Identifier Type: -

Identifier Source: org_study_id

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