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Getting Global Rare Disease Insights Through Technology Study (GRIT)

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ClinicalTrials.gov Identifier: NCT04758130
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Hanalytics Solutions Inc.
Information provided by (Responsible Party):
M.A.G.I.C. Clinic LTD

Brief Summary:

This project is a randomized controlled trial to use a mobile health journal, called Zamplo (formerly known as MyHealthJournal or ZoeInsights), to record patient reported outcomes (PROM) in patients with metabolic disorders.

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.


Condition or disease Intervention/treatment Phase
Metabolic Disease Fabry Disease Gaucher Disease Pompe Disease Mitochondrial Diseases Other: Zamplo Digital Health Platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The G.R.I.T. Study: Getting Global Rare Disease Insights Through Technology
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : November 30, 2021


Arm Intervention/treatment
Experimental: App Group
Patients in this group are provided with a link to download the application and their application usage is tracked by the clinic.
Other: 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 Comparator: Placebo Group
Patients in this group are not provided with the clinic link to the application.
Other: 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.




Primary Outcome Measures :
  1. Patient Activation [ Time Frame: 3 Months post baseline ]
    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. The survey will be completed by participants of the two groups at baseline and follow-up time-points.


Secondary Outcome Measures :
  1. Self-Efficacy for Managing Chronic Conditions (PROMIS) [ Time Frame: 3 Months ]
    Manage Medications/Treatment: Self-efficacy is defined as confidence in one's ability to successfully perform specific tasks or behaviors. Self Efficacy for Managing Chronic Conditions assesses confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. Confidence in managing medication schedules of different complexity.

  2. Patient Satisfaction [ Time Frame: 3 Months ]
    This is a survey question asked during Alberta Health Quality Assessments Q11. "Thinking about all of your personal experiences within the past year with the healthcare services in Alberta that we just reviewed, to what degree are you satisfied or dissatisfied with the services you have received?"

  3. Acceptability [ Time Frame: 3 Months ]
    The acceptability of Zamplo will be assessed by patients and informal caregivers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with a diagnosis of metabolic disease
  • 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758130


Contacts
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Contact: Desmond Koo +1 (403) 888-3278 clinicaltrials@calgarymetabolics.hush.com

Locations
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Canada, Alberta
M.A.G.I.C. Clinic LTD Recruiting
Calgary, Alberta, Canada, T2M0L6
Contact: Desmond Koo    +1 (403) 888-3278    clinicaltrials@calgarymetabolics.hush.com   
Sponsors and Collaborators
M.A.G.I.C. Clinic LTD
Hanalytics Solutions Inc.
Additional Information:
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Responsible Party: M.A.G.I.C. Clinic LTD
ClinicalTrials.gov Identifier: NCT04758130    
Other Study ID Numbers: GRIT
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fabry Disease
Gaucher Disease
Glycogen Storage Disease Type II
Metabolic Diseases
Mitochondrial Diseases
Rare Diseases
Disease Attributes
Pathologic Processes
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Lipid Metabolism Disorders
Glycogen Storage Disease
Carbohydrate Metabolism, Inborn Errors