Osteogenesis ImperfectaTele OINCT06555536
e-Health Care Method for Patients With Osteogenesis Imperfecta (Tele OI)
A study testing Tele OI in people with Osteogenesis Imperfecta, run by Paulo Humberto Mem Martendal Vallandro Costa at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Tele OI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2022to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Tele OI
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele OIOther
A data collection and Telemedicine tool translated into an APP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tele OI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Oct 2022
- Primary completion9 May 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an Interventional Clinical Trial without a Control Group that was carried out in a population of patients with Osteogenesis Imperfecta.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulo Humberto Mem Martendal Vallandro Costa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paulo Humberto Mem Martendal Vallandro Costa, Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555536
- Sponsor's protocol ID
- SCSP
- Acronym
- Tele OI
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Using the Telemedicine and e-Health Care Method for Patients With Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT06555536
- Acronym / sponsor ID
- Tele OI / SCSP
- Conditions
- Osteogenesis Imperfecta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Paulo Humberto Mem Martendal Vallandro CostaUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an Interventional Clinical Trial without a Control Group that was carried out in a population of patients with Osteogenesis Imperfecta.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine and e-Health care method for patients with Osteogenesis Imperfecta. | Experimental | Other: Tele OIThis 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. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele OIA data collection and Telemedicine tool translated into an APP. | Other | Telemedicine and e-Health care method for patients with Osteogenesis Imperfecta. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Related trials for Osteogenesis Imperfecta
Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Osteogenesis Imperfecta (OI)
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
Active, not recruitingPhase 2/3
Setrusumab vs Placebo for Osteogenesis Imperfecta
Osteogenesis Imperfecta
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele OI in people with Osteogenesis Imperfecta, run by Paulo Humberto Mem Martendal Vallandro Costa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Functional Independence Measure (FIM) in OI patients using e-Health (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.