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

NCT06555536 | Completed

• 1 other identifier: SCSP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Tele OI OTHER

A data collection and Telemedicine tool translated into an APP.

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

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Paulo Humberto Mem Martendal Vallandro Costa: lead

Study Sites (1)

Santa Casa de São Paulo

São Paulo, São Paulo, 01221-020, Brazil

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an Interventional Clinical Trial without a Control Group that was carried out in a population of patients with Osteogenesis Imperfecta.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 15, 2024
• Study Start: October 20, 2022
• Primary Completion: May 9, 2023
• Study Completion: October 20, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

BR (1)