Getting Global Rare Disease Insights Through Technology Study

Metabolic Disease Clinical Trial

— GRIT  

Official title:

The G.R.I.T. Study: Getting Global Rare Disease Insights Through Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758130
• Other study ID #: GRIT
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2021
• Source: M.A.G.I.C. Clinic LTD
• Contact: Desmond Koo
• Phone: +1 (403) 888-3278
• Email: clinicaltrials[@]calgarymetabolics.hush.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fabry Disease
• Gaucher Disease
• Glycogen Storage Disease Type II
• Metabolic Disease
• Metabolic Diseases
• Mitochondrial Diseases
• Pompe Disease
• Rare Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	M.A.G.I.C. Clinic LTD	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
M.A.G.I.C. Clinic LTD	Hanalytics Solutions Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activation	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.	3 Months post baseline
Secondary	Self-Efficacy for Managing Chronic Conditions (PROMIS)	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.	3 Months
Secondary	Patient Satisfaction	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 Months
Secondary	Acceptability	The acceptability of Zamplo will be assessed by patients and informal caregivers.	3 Months

External Links

•   Link to request information about the study