e-Health Care Method for Patients With Osteogenesis Imperfecta (Tele OI)

NCT ID: NCT06555536

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2023-10-20

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.

Conditions

Osteogenesis Imperfecta

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemedicine and e-Health care method for patients with Osteogenesis Imperfecta.

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.

Group Type: EXPERIMENTAL

Tele OI

Intervention Type: OTHER

A data collection and Telemedicine tool translated into an APP.

Interventions

Tele OI

A data collection and Telemedicine tool translated into an APP.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paulo Humberto Mem Martendal Vallandro Costa

OTHER

Sponsor Role: lead

Responsible Party

Paulo Humberto Mem Martendal Vallandro Costa

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Santa Casa de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

SCSP

Identifier Type: -

Identifier Source: org_study_id