Getting Global Rare Disease Insights Through Technology Study
NCT ID: NCT04758130
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-08-07
2021-11-30
Brief Summary
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The objective of the study is to assess the feasibility, acceptability and potential effectiveness of the Zamplo.
The primary hypothesis is as follows:
The Zamplo platform will significantly increase patient activation at 6 months post-baseline, defined as an individual's knowledge, skill, and confidence for managing their health and health care.
The primary outcome is as follows:
Patient activation following the use of Zamplo will serve as the primary outcome of interest and will be measured by the Patient Activation Measure (PAM) 13. The PAM 13 shows the degree of the patient's ability to manage their health with confidence by providing a total patient activation score.
Brief Background:
This project is a randomized controlled trial to use a mobile health journal, called Zamplo, to record patient reported outcomes (PROM) in patients with metabolic disorders.
Zamplo is a software as a service (SaaS) digital platform on both iOS and Android platforms that allows real-time entry of patient symptoms and response to medications. It provides the patients with an interface to see their progress, store questions that they will ask at the next clinic visit, record their health data and use their data to engage in their health outcomes. MAGIC Clinic Ltd., which is the largest clinic in Alberta that manages metabolic disorders such as Fabry disease, Pompe disease, and Gaucher disease, will provide access to Zamplo to patients free-of-charge to evaluate its utility in managing the symptoms of their disease.
Brief Study Design:
The study is a two-armed randomized controlled design with 1:1 allocation to treatment (Zamplo app group) or control (usual care) arms, with assessments at four time points: baseline, 1 month, 3 months (primary outcome), 6 months and 12 months follow-up post-baseline. This is an open-label trial.
The investigators intend to recruit 150 participants in this study, with 75 of them being controls.
Inclusion Criteria:
Adult patients with a diagnosis of metabolic disease Access to a smartphone with data connection Willingness to devote 10-15 mins of time in a day to log medications and notes Able to speak and write English sufficiently to complete questionnaires.
Exclusion Criteria:
Insufficient cognitive function to participate in the study The use of any electronic application requires some competency with the software on a cellphone, downloading the application and entering the data. Some patients who are elderly may not be familiar with this technology and would be excluded.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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App Group
Patients in this group are provided with a link to download the application and their application usage is tracked by the clinic.
Zamplo Digital Health Platform
This application will be provided to patients and provide them with a method to track various data related to their metabolic disease.
Placebo Group
Patients in this group are not provided with the clinic link to the application.
Zamplo Digital Health Platform
This application will be provided to patients and provide them with a method to track various data related to their metabolic disease.
Interventions
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Zamplo Digital Health Platform
This application will be provided to patients and provide them with a method to track various data related to their metabolic disease.
Eligibility Criteria
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Inclusion Criteria
* Access to a smartphone/computer with data connection
* Willingness to devote 10-15 mins of time in a day to log medications and notes
* Able to speak and write English sufficiently to complete questionnaires
Exclusion Criteria
* The use of any electronic application requires some competency with the software on a cellphone, downloading the application and entering the data. Some patients who are elderly may not be familiar with this technology and would be excluded.
18 Years
ALL
No
Sponsors
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Hanalytics Solutions Inc.
UNKNOWN
M.A.G.I.C. Clinic LTD
INDUSTRY
Responsible Party
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Locations
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M.A.G.I.C. Clinic LTD
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Link to request information about the study
Other Identifiers
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GRIT
Identifier Type: -
Identifier Source: org_study_id
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