Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h) (DIG-PROMs-h)
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| ClinicalTrials.gov Identifier: NCT04749511 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Quality of Life | Behavioral: Extrambulatory digital PROMs detection | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto al Rilevamento PROMs Ambulatoriale Standard Nella Protesica d'Anca |
| Actual Study Start Date : | November 30, 2020 |
| Estimated Primary Completion Date : | October 1, 2021 |
| Estimated Study Completion Date : | January 1, 2022 |
- 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.
- Patient's adhesion to the digital compilation after the pre-admission visit [ Time Frame: 1 month before surgery (pre-admission outpatient visit) ]
Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC index compared to the conventional one.
Those who complete the questionnaire within 48 hours of the outpatient visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
- Patient's adhesion to the digital compilation one month after surgery [ Time Frame: 1 month after surgery (follow up visit) ]
Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC index compared to the conventional one.
Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
- Patient's adhesion to the digital compilation three months after surgery [ Time Frame: 3 months after surgery (follow up visit) ]
Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC index compared to the conventional one.
Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
- Patient's adhesion to the digital compilation six months after surgery [ Time Frame: 6 months after surgery (follow up visit) ]
Adhesion: The primary end point will be assessed in terms of patient adhesion at the digital survey of the WOMAC index compared to the conventional one.
Those who complete the questionnaire within 48 hours of the follow up visit will be considered as cases with positive adhesion with the digital assessment; those who reply after 48 hours or who do not reply will be considered with negative adhesion.
- 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) ]
As a secondary end point, the 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 will be examined, one month before surgery, on the occasion of the pre-admission visit.
Which and how many responses will be discordant with respect to the two types of survey will be indicated.
- 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) ]
As a secondary end point, the 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 will be examined, one month after surgery, on the occasion of the follow up visit.
Which and how many responses will be discordant with respect to the two types of survey will be indicated.
- 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) ]
As a secondary end point, the 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 will be examined, three months after surgery, on the occasion of the follow up visit.
Which and how many responses will be discordant with respect to the two types of survey will be indicated.
- 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) ]
As a secondary end point, the 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 will be examined, six months after surgery, on the occasion of the follow up visit.
Which and how many responses will be discordant with respect to the two types of survey will be indicated.
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| Ages Eligible for Study: | 18 Years to 78 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749511
| Contact: Cesare Stagni, Dr | 00393473910599 | cesare.stagni@ior.it | |
| Contact: Giuseppe Di Sante, Dr | 00393286491562 | giuseppe.disante@ior.it |
| Italy | |
| Istituto Ortopedico Rizzoli | Recruiting |
| Bologna, Italia, Italy, 40136 | |
| Contact: Cesare Stagni, Dr 00393473910599 cesare.stagni@ior.it | |
| Contact: giuseppe di sante, Dr 00393286491562 giuseppe.disante@ior.it | |
| Responsible Party: | Dante Dallari, MD, Director of Complex Structure Orthopaedic Reconstructive Surgery Innovative Techniques - Musculoskeletal Tissue Bank, Istituto Ortopedico Rizzoli |
| ClinicalTrials.gov Identifier: | NCT04749511 |
| Other Study ID Numbers: |
CE-AVEC 583/2020 / Oss / IOR |
| First Posted: | February 11, 2021 Key Record Dates |
| Last Update Posted: | February 11, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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PROMs Digital Hip prosthesis WOMAC score |