Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555536
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
e-Health Care Method for Patients With Osteogenesis Imperfecta Tele OI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Study Using the Telemedicine and e-Health Care Method for Patients With Osteogenesis Imperfecta
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tele OI
Brief Summary:
This work seeks to formalize the association between the use of technology and the effective treatment of patients with Osteogenesis Imperfecta which has not yet been explored in the literature and aims to prove functional improvement in patients using the MIF scale Functional Independence Measure and telemedicine care in addition to telephysiotherapy to reduce the cost of treatment allowing the patient to be treated without leaving their home and bringing greater effectiveness to the follow-up of these patients
Detailed Description:
This is an Interventional Clinical Trial without a Control Group that was carried out in a population of patients with Osteogenesis Imperfecta To implement this intervention in these patients a period of 18 months was required to develop the two pillars that support it a data collection tool and Telemedicine translated into a dedicated APP and a YouTube channel with visual guidelines for strengthening exercises and immobilization for possible fractures The tool was developed through the use of computer programming language more specifically JavaScript and today translates into a data collection platform in addition to also being the virtual environment where participants receive physiotherapy guidance and where they report emergency situations receiving pre-hospital care
The first consultation of all participants in accordance with resolution 22272018 of the Federal Council of Medicine in Brazil was carried out in person and all telemedicine care was provided within the outpatient clinics of the Orthopedics Department of Santa Casa de São Paulo since the records in the medical records were made in the institutions electronic medical record Soul MV The intervention began on October 20 2022 and data were collected until October 20 2023 although the project remained active and collecting new data due to its success in terms of outcomes During this period multidisciplinary monitoring was carried out being monthly with the orthopedic doctor and the physiotherapist in a digital and synchronous manner This monitoring was changed only in the case of fractures
During the follow-up over the almost one-year period of the intervention the investigators prescribed digital physiotherapy suggesting that participants perform the activities at least 3 times a week asynchronously a demand met by almost all The investigators carry out multidisciplinary consultations via telemedicine every 3 months changing physiotherapy training within this period to change the stimulation given to the muscles
The first consultation of all participants in accordance with resolution 22272018 of the Federal Council of Medicine in Brazil was carried out in person and all telemedicine care was provided within the outpatient clinics of the Orthopedics Department of Santa Casa de São Paulo since the records in the medical records were made in the institutions electronic medical record Soul MV The intervention began on October 20 2022 and data were collected until October 20 2023 although the project remained active and collecting new data due to its success in terms of outcomes During this period multidisciplinary monitoring was carried out being monthly with the orthopedic doctor and the physiotherapist in a digital and synchronous manner This monitoring was changed only in the case of fractures
During the follow-up over the almost one-year period of the intervention the investigators prescribed digital physiotherapy suggesting that participants perform the activities at least 3 times a week asynchronously a demand met by almost all The investigators carry out multidisciplinary consultations via telemedicine every 3 months changing physiotherapy training within this period to change the stimulation given to the muscles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None