Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extrambulatory digital PROMs detection.
- Who it may be relevant to
- Registry conditions: Quality of Life. Basic parameters: 18 years — 78 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto al Rilevamento PROMs Ambulatoriale Standard Nella Protesica d'Anca
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.
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Patient's adhesion to the digital compilation after the pre-admission visit [Time frame: 1 month before surgery (pre-admission outpatient visit)]
- Patient's adhesion to the digital compilation one month after surgery [Time frame: 1 month after surgery (follow up visit)]
- Patient's adhesion to the digital compilation three months after surgery [Time frame: 3 months after surgery (follow up visit)]
- Patient's adhesion to the digital compilation six months after surgery [Time frame: 6 months after surgery (follow up visit)]
Secondary outcome measures (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 [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 [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 [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 [Time frame: 6 months after surgery (follow up visit)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT04749511 · CE-AVEC 583/2020 / Oss / IOR