Metabolic DiseaseGRITNCT04758130
Getting Global Rare Disease Insights Through Technology Study
A study testing Zamplo Digital Health Platform in people with Metabolic Disease and Fabry Disease, run by M.A.G.I.C. Clinic LTD at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Disease, Fabry Disease, Gaucher Disease
- What is being tested?
- Zamplo Digital Health Platform
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2020to 30 Nov 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
M.A.G.I.C. Clinic LTD
Calgary, Alberta, T2M0L6
Desmond Koo, +1 (403) 888-3278, clinicaltrials@calgarymetabolics.hush.com
About this study
Official title: The G.R.I.T. Study: Getting Global Rare Disease Insights Through Technology
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.
Read more
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.
- Being tested
- Zamplo Digital Health Platform
- Medical subject headings
- Metabolic Diseases, Fabry Disease, Gaucher Disease, Glycogen Storage Disease Type II, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zamplo Digital Health PlatformOther
This application will be provided to patients and provide them with a method to track various data related to their metabolic disease.
| Study group | Role | What they receive |
|---|---|---|
| App Group | Experimental | Patients in this group are provided with a link to download the application and their application usage is tracked by the clinic. Receives: Other: Zamplo Digital Health Platform |
| Placebo Group | Placebo comparator | Patients in this group are not provided with the clinic link to the application. Receives: Other: Zamplo Digital Health Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months post baseline
Secondary outcomes (3)
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.
Measured: 3 Months
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?"
Measured: 3 Months
Acceptability
The acceptability of Zamplo will be assessed by patients and informal caregivers.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start7 Aug 2020
- Primary completion15 May 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.A.G.I.C. Clinic LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanalytics Solutions Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758130
- Sponsor's protocol ID
- GRIT
- Acronym
- GRIT
- Status last verified
- Apr 2021
- First submitted
- 21 Jan 2021
- Last updated
- 8 Apr 2021
- Results posted
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The G.R.I.T. Study: Getting Global Rare Disease Insights Through Technology
- ClinicalTrials.gov ID
- NCT04758130
- Acronym / sponsor ID
- GRIT / GRIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.A.G.I.C. Clinic LTDIndustry (pharma, biotech, devices)
- Collaborators
- Hanalytics Solutions Inc.
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 17 Feb 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App Group | Experimental | Other: Zamplo Digital Health PlatformPatients in this group are provided with a link to download the application and their application usage is tracked by the clinic. |
| Placebo Group | Placebo comparator | Other: Zamplo Digital Health PlatformPatients in this group are not provided with the clinic link to the application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Zamplo Digital Health PlatformThis application will be provided to patients and provide them with a method to track various data related to their metabolic disease. | Other | App Group, Placebo Group |
Primary outcome
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.
3 secondary outcomes
Self-Efficacy for Managing Chronic Conditions (PROMIS)
Time frame: 3 Months
Patient Satisfaction
Time frame: 3 Months
Acceptability
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Link to request information about the studyLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zamplo Digital Health Platform in people with Metabolic Disease and Fabry Disease, run by M.A.G.I.C. Clinic LTD at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Desmond Koo (+1 (403) 888-3278, clinicaltrials@calgarymetabolics.hush.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: 3 Months post baseline). 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 8 Apr 2021.