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
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-11-30
2027-03-01
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 psychiatric pathologies, a history of drug and alcohol abuse
* patients not in possession of private digital electronic support
18 Years
78 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, Italia, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CE-AVEC 583/2020 / Oss / IOR
Identifier Type: -
Identifier Source: org_study_id
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