Clinical trial NCT06555536: e-Health Care Method for Patients With Osteogenesis Imperfecta (Tele OI)
Official title: Prospective Study Using the Telemedicine and e-Health Care Method for Patients With Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteogenesis Imperfecta
Lead sponsor: Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an Interventional Clinical Trial without a Control Group that was carried out in a population of patients with Osteogenesis Imperfecta.
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* Osteogenesis Imperfecta patients
* Patients over 3 years old
* Patients must have a smartphone with the possibility of internet access and the capacity to support the Google Meet program (used in teleconsultations).

Exclusion Criteria:

* Patients under 3 years of age
* Patients without any access to any type of internet
* Patients undergoing treatment with pamindronate
* Patients who, due to their older age (above 60 years), were not familiar with a cell phone device to use our application and follow the therapy remotely

Primary outcomes:
measure: Change Functional Independence Measure (FIM) in OI patients using e-Health
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Casa de São Paulo
state: Sao Paulo
Study officials:
References: