Gaucher DiseaseNCT04997772
Digital Health Platform Customized for Patients With Gaucher Disease
An observational study of Gaucher Disease and Patient Reported Outcome, run by Shoshana Vilk at 1 site in Israel.
Trial summary
The entry of digitization into the world in recent years is helping the health care system to operate more efficiently than in the past and has increased the participation of patients and their families in managing their health care. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gaucher Disease, Patient Reported Outcome
- What is being tested?
- Digital Gaucher Platform
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2022to 30 Mar 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Gaucher disease patients above the age of 18 years old.
Who may be able to join
- All adults (>18 years, no age maximum) treated patients with GD will be eligible.
- Signed informed consent.
Who cannot join
- Patients without access to either computer or mobiles phone.
- For this pilot study patients whose communication skills in Hebrew is not good enough to complete the study questionnaires and PROMs [the app platform will use a very simplified language, thus allowing patients with limited Hebrew to use the app] *for future use/study the platform will be translated to other languages, as needed.
Trial locations and contacts
1 site in 1 country.
About this study
The entry of digitization into the world in recent years is helping the health care system to operate more efficiently than in the past and has increased the participation of patients and their families in managing their health care.
In a rare disease, such as Gaucher disease, patient involvement through digital technology is of great importance. Gaucher patients come for an inspection at the Gaucher unit once every six months. However, medical events, related and unrelated to Gaucher, may occur between these visits, some of which may be urgent. A digital Gaucher platform will allow for the updating of medical events occurring in the patient between these visits and will allow specialists to give up-to-date medical advice to the patient and the local doctor when needed. The Gaucha Digital Platform will provide digital tools (and applications) for self-management, monitoring and regular contact with the Gaucher Unit. The system will have an alert system that will allow accessible communication between the patient and the Gaucher unit. Moreover, patients with Gaucher disease need a lifelong commitment to their care; Enzyme replacement therapy (ERT) and substrate inhibitor therapy (SRT). When patients are monitored only once or twice a year, monitoring adherence to treatment may be a problem. Adherence to the treatment regimen is essential for achieving normalization. The system will have a system of reminders for treatment and a system for monitoring the receipt of treatment. The digital system will include quality of life questionnaires and pain questionnaires that will help to more comprehensively understand the patient's condition.
Finally, a Gaucher-adapted digital platform will ensure the collection of all relevant clinical data that is important for the treatment of a rare and multi-systemic disease such as Gaucher disease. A complete database will make it possible to create an anonymous database that will be used to find predictors of response to treatment, complications and commodities associated with Gaucher disease.
Read the detailed description
With quality outcomes and value, the watchwords for health care in the 21st century, stakeholders around the globe are looking for innovative, cost-effective ways to deliver patient-centered, technology-enabled "smart" healthcare, both inside and outside hospital walls.The Digital transformation in health and care aims at supporting the management of health and well being while empowering the participation of people and facilitating the transformation of health and care services to more digitized, person-centered and community-based care models, thereby enabling better access to healthcare and the sustainability of health and care systems.
Globally, the investigators see also an increase in the desire of patients themselves to play an active role in their healthcare management. In rare disease, such as Gaucher Disease (GD), patient engagement through a combined digital technology may have added importance. It is recommended for patients with GD to be managed by a multidisciplinary team of experts having long-term experience with the diverse clinical manifestations and potential GD-related or unrelated co-morbidities, their follow-up visits at the center of excellence are usually on an annual or semi-annual basis. However, disease-related and un-related medical events may occur in-between these visits, some which may be emergent. A digital Gaucher platform will enable updating medical events occurring to the patient in-between these visits and enable the specialists to give updated medical consult to the patient and local physician when needed.
Furthermore, patients with GD need a life-long commitment to their therapy; enzyme replacement therapy (ERT) and substrate reduction therapy (SRT). The adherence to therapy regimen is essential to achieve normalization. When patients are followed only once-twice a year in a specialized clinic following the adherence to therapy might be a problem. A digital Gaucher-platform will provide digital tools (and applications) for self-management, adherence, and patient-reported outcome using a Gaucher-dedicated APP. Alert dashboard will be developed and installed for the health professionals in order to enable accessible communication between the patient and health professionals and be able to respond in a timely manner.
Patient-reported outcome (PRO) and Patient-reported outcome measures (PROMs) are increasingly important in research and clinical practice and to monitor the efficiency of health care services. The use of PROMs is fundamental to ensure that what matters to patients is captured in a valid, reliable, responsive, and feasible manner. A Digital Gaucher Platform can collect GD-specific PROMs.
Finally, a digital Gaucher platform will ensure capturing all relevant clinical data, full data files, and complete missing data, important endeavor for the treatment of the individual patients with a rare and multi-system disease such as GD. Data completion is essential for the development of a database, agnostic to pharma companies or ways of treatment, with high-quality real-time data. This database can then be used for big data analysis for finding predictors for GD-related complications and commodities.
- Conditions
- Gaucher Disease, Patient Reported Outcome
- Being tested
- Digital Gaucher Platform
- Keywords
- Gaucher Disease, Digital Health, Patient Reported Outcome
- Medical subject headings
- Gaucher Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Gaucher PlatformDevice
Digital platform specified for Gaucher patients.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Gaucher disease patients > 18 years old. Receives: Device: Digital Gaucher Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of satisfaction from Gaucher treatment at baseline compared to the end of study
GD-PROMs
Measured: 12 months
Secondary outcomes (2)
Adherence to treatment based on participant reports in the App
participants report in the app
Measured: 12 months
Achievement of treatment goals based on Gaucher consensus paper
Gaucher consensus paper
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Feb 2022
- Primary completion28 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gaucher DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shoshana Vilk
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor-investigator, Shoshana Vilk, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997772
- Sponsor's protocol ID
- 0380-20-SZMC
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Platform Customized for Patients With Gaucher Disease
- ClinicalTrials.gov ID
- NCT04997772
- Acronym / sponsor ID
- 0380-20-SZMC
- Conditions
- Gaucher Disease, Patient Reported Outcome
- Keywords
- Gaucher Disease, Digital Health, Patient Reported Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shoshana VilkUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 10 Aug 2021 (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.
The entry of digitization into the world in recent years is helping the health care system to operate more efficiently than in the past and has increased the participation of patients and their families in managing their health care.
In a rare disease, such as Gaucher disease, patient involvement through digital technology is of great importance. Gaucher patients come for an inspection at the Gaucher unit once every six months. However, medical events, related and unrelated to Gaucher, may occur between these visits, some of which may be urgent. A digital Gaucher platform will allow for the updating of medical events occurring in the patient between these visits and will allow specialists to give up-to-date medical advice to the patient and the local doctor when needed. The Gaucha Digital Platform will provide digital tools (and applications) for self-management, monitoring and regular contact with the Gaucher Unit. The system will have an alert system that will allow accessible communication between the patient and the Gaucher unit. Moreover, patients with Gaucher disease need a lifelong commitment to their care; Enzyme replacement therapy (ERT) and substrate inhibitor therapy (SRT). When patients are monitored only once or twice a year, monitoring adherence to treatment may be a problem. Adherence to the treatment regimen is essential for achieving normalization. The system will have a system of reminders for treatment and a system for monitoring the receipt of treatment. The digital system will include quality of life questionnaires and pain questionnaires that will help to more comprehensively understand the patient's condition.
Finally, a Gaucher-adapted digital platform will ensure the collection of all relevant clinical data that is important for the treatment of a rare and multi-systemic disease such as Gaucher disease. A complete database will make it possible to create an anonymous database that will be used to find predictors of response to treatment, complications and commodities associated with Gaucher disease.
Detailed description
With quality outcomes and value, the watchwords for health care in the 21st century, stakeholders around the globe are looking for innovative, cost-effective ways to deliver patient-centered, technology-enabled "smart" healthcare, both inside and outside hospital walls.The Digital transformation in health and care aims at supporting the management of health and well being while empowering the participation of people and facilitating the transformation of health and care services to more digitized, person-centered and community-based care models, thereby enabling better access to healthcare and the sustainability of health and care systems.
Globally, the investigators see also an increase in the desire of patients themselves to play an active role in their healthcare management. In rare disease, such as Gaucher Disease (GD), patient engagement through a combined digital technology may have added importance. It is recommended for patients with GD to be managed by a multidisciplinary team of experts having long-term experience with the diverse clinical manifestations and potential GD-related or unrelated co-morbidities, their follow-up visits at the center of excellence are usually on an annual or semi-annual basis. However, disease-related and un-related medical events may occur in-between these visits, some which may be emergent. A digital Gaucher platform will enable updating medical events occurring to the patient in-between these visits and enable the specialists to give updated medical consult to the patient and local physician when needed.
Furthermore, patients with GD need a life-long commitment to their therapy; enzyme replacement therapy (ERT) and substrate reduction therapy (SRT). The adherence to therapy regimen is essential to achieve normalization. When patients are followed only once-twice a year in a specialized clinic following the adherence to therapy might be a problem. A digital Gaucher-platform will provide digital tools (and applications) for self-management, adherence, and patient-reported outcome using a Gaucher-dedicated APP. Alert dashboard will be developed and installed for the health professionals in order to enable accessible communication between the patient and health professionals and be able to respond in a timely manner.
Patient-reported outcome (PRO) and Patient-reported outcome measures (PROMs) are increasingly important in research and clinical practice and to monitor the efficiency of health care services. The use of PROMs is fundamental to ensure that what matters to patients is captured in a valid, reliable, responsive, and feasible manner. A Digital Gaucher Platform can collect GD-specific PROMs.
Finally, a digital Gaucher platform will ensure capturing all relevant clinical data, full data files, and complete missing data, important endeavor for the treatment of the individual patients with a rare and multi-system disease such as GD. Data completion is essential for the development of a database, agnostic to pharma companies or ways of treatment, with high-quality real-time data. This database can then be used for big data analysis for finding predictors for GD-related complications and commodities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Digital Gaucher PlatformGaucher disease patients > 18 years old. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Gaucher disease patients above the age of 18 years old.
Key inclusion criteria (2 listed)
- All adults (>18 years, no age maximum) treated patients with GD will be eligible.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Patients without access to either computer or mobiles phone.
- For this pilot study patients whose communication skills in Hebrew is not good enough to complete the study questionnaires and PROMs [the app platform will use a very simplified language, thus allowing patients with limited Hebrew to use the app] *for future use/study the platform will be translated to other languages, as needed.
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 |
|---|---|---|
| Digital Gaucher PlatformDigital platform specified for Gaucher patients. | Device | 1 |
Primary outcome
Rate of satisfaction from Gaucher treatment at baseline compared to the end of study
Time frame: 12 months
GD-PROMs
2 secondary outcomes
Adherence to treatment based on participant reports in the App
Time frame: 12 months
Achievement of treatment goals based on Gaucher consensus paper
Time frame: 12 months
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 17 Apr 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Gaucher Disease and Patient Reported Outcome, run by Shoshana Vilk at 1 site in Israel.
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 2 inclusion and 2 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 17 Apr 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 Israel. 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?
Rate of satisfaction from Gaucher treatment at baseline compared to the end of study (time frame: 12 months). 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 17 Apr 2024.