An interventional study of Tele OI in Osteogenesis Imperfecta, sponsored by Paulo Humberto Mem Martendal Vallandro Costa. Completed at 1 site in Brazil. Open to participants aged 3 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Paulo Humberto Mem Martendal Vallandro Costa · Not applicable, Interventional, and Supportive care
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.
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 2227/2018 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 institution's 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.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 15 is below the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.
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This study seeks to formalize the association between the use of technology and the effective treatment of patients with Osteogenesis Imperfecta, not yet explored in the literature.
Other: Tele OI
A data collection and Telemedicine tool translated into an APP.
Change Functional Independence Measure (FIM) in OI patients using e-Health
Demonstrate functional improvement of patients, using the FIM scale (Functional Independence Measure) before and after 1 year of intervention using telemedicine care in addition to telephysiotherapy remotely. This scale (FIM) ranges from 7 (minimum and worse outcome) to 126 (maximum and better outcome) and includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. The tool (FIM) is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.
Time frame: 1 year
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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