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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Shaare Zedek Medical Center

    Jerusalem, 9103102

Other trials in Israel

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.

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 groups in NCT04997772
Study groupRoleWhat they receive
1Gaucher 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.

  1. Rate of satisfaction from Gaucher treatment at baseline compared to the end of study

    GD-PROMs

    Measured: 12 months

Secondary outcomes (2)
  1. Adherence to treatment based on participant reports in the App

    participants report in the app

    Measured: 12 months

  2. 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.

  1. First posted10 Aug 2021
  2. Study start1 Feb 2022
  3. Primary completion28 Feb 2024
  4. Study completion30 Mar 2024

Resources

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)
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

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.

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