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

August 14, 2024 updated by: Paulo Humberto Mem Martendal Vallandro Costa

Prospective Study Using the Telemedicine and e-Health Care Method for Patients With Osteogenesis Imperfecta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01221-020
        • Santa Casa de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Tele OI
A data collection and Telemedicine tool translated into an APP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Functional Independence Measure (FIM) in OI patients using e-Health
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paulo Humberto Mem Martendal Vallandro Costa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCSP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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