RecruitingNot Applicable

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

Italy50 participantsStarted 2020-11-30

Plain-language 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.

Who can participate

Age range

18 Years – 78 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient's adhesion to the digital compilation after the pre-admission visit

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

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

Timeframe: 1 month after surgery (follow up visit)

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

Timeframe: 3 months after surgery (follow up visit)

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

Timeframe: 6 months after surgery (follow up visit)

Trial details

NCT IDNCT04749511

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Cesare Stagni, Dr

00393473910599 cesare.stagni@ior.it

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