Идёт набор NCT04749511

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

Без фазы С лечением Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Extrambulatory digital PROMs detection.
Кому может быть актуально: Состояния в реестре: Quality of Life. Базовые параметры: 18 лет — 78 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto al Rilevamento PROMs Ambulatoriale Standard Nella Protesica d'Anca

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Patient's adhesion to the digital compilation after the pre-admission visit [Срок оценки: 1 month before surgery (pre-admission outpatient visit)]
Patient's adhesion to the digital compilation one month after surgery [Срок оценки: 1 month after surgery (follow up visit)]
Patient's adhesion to the digital compilation three months after surgery [Срок оценки: 3 months after surgery (follow up visit)]
Patient's adhesion to the digital compilation six months after surgery [Срок оценки: 6 months after surgery (follow up visit)]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 6 months after surgery (follow up visit)]

Критерии участия

Критерии включения

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)