Diabetes Mellitus, Type 1NCT05979077
Children's Hospital Academic Medical Organization (CHAMO) MyChart Study
A study testing MyChart Questionnaire in people with Diabetes Mellitus, Type 1, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
Evolving technology and clinical innovation have led to dramatic changes in the management of type 1 diabetes (T1D). These changes have led to a need to collect a growing number of details from families during their visits. Read more about this study
- Who is it for?
- Ages 0 years to 131 months
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- MyChart Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 years to 131 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of T1D
- Age <11 years at enrollment
Who cannot join
- Patients ≥ 11 years of age at enrollment
- Patients who are not fluent enough in English to complete all study related procedures
- Patients unable or unwilling to provide consent and/or assent
- Patients followed in Eating Disorder Clinic or Child and Youth Protection Clinic (there are MyChart activation restrictions for individuals followed in these clinics)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital of Eastern Ontario - Research Institute
Ottawa, Ontario, K1H 8L1
About this study
Official title: Improving Quality of Care in Diabetes Clinic Through Patient-Entered Electronic Health Data?
Evolving technology and clinical innovation have led to dramatic changes in the management of type 1 diabetes (T1D). These changes have led to a need to collect a growing number of details from families during their visits. As a result, much of the physician-patient visit is spent transferring information instead of focusing on diabetes care, contributing to increased time pressures in clinic and unmet needs for patients.
In response to this reality, the investigators have developed a tool that allows families to input their diabetes-related information into their physicians' electronic health record (EHR) documentation tool before their clinic visit, using a questionnaire administered via CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes control and clinic efficiency. The investigators hope that our study will determine whether having families input clinical data prior to a visit is an effective strategy to improve the quality of diabetes care. The investigators believe that the findings will be of interest to all those studying the value of incorporating patient-entered data both within diabetes care and beyond.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- MyChart Questionnaire
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChart QuestionnaireOther
Prior to clinic visits, families completing the MyChart Questionnaire will enter details about their current management and visit goals, automatically populating their electronic health record for subsequent review/revision by the health care team before and during the visit, reallocating clinic time previously used for data acquisition to individual patient priorities
| Study group | Role | What they receive |
|---|---|---|
| MyChart Questionnaire (Intervention Group) | Experimental | Participants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire. Receives: Other: MyChart Questionnaire |
| Standard Clinical Care (Control Group) | No intervention | Participants within the control group will undergo standard clinical care with no study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.
The EHR-enabled questionnaire will be completed through the online MyChart portal. Patients' parents are required to complete diabetes-related questions across a total of 10 pages, including questions regarding the visit, insulin dosing, injection dose, insulin delivery, blood sugar monitoring, high blood glucose and ketones, hypoglycemia, nutrition, physical activity, and general health. These questions are typically addressed during routine clinic visits; however, they will be completed prior to the clinic visit and automatically entered into the patient's medical chart.
Measured: 12 months
Patients' Evaluation of Quality of Diabetes Care (PEQD)
The PEQD is a brief and validated questionnaire designed to assess the participants' judgement about the quality of their diabetes care. It is scored on a scale of 0-100 with 100 representing the best possible quality of care.
Measured: 12 months
Perceived Quality of Medical Care (PQMC)
The PQMC is a validated instrument designed to provide a simple, general measure of patients' overall quality of medical care they receive. Alpha reliability estimates should be expected to be above .90 for this instrument. It is scored on a scale from 6-42, with lower scores representing better perceived quality of medical care.
Measured: 12 months
Participant Tool and Workflow Survey
This study-specific questionnaire was developed during pilot work for this study and was designed to specifically assess the myChart questionnaire being completed before each clinic visit. This questionnaire will only be given to those participants randomized to the intervention group. While this questionnaire has not been validated, it has been used in previously published research by our study team.
Measured: 12 months
Secondary outcomes (1)
To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.
Changes in glycemic control will be obtained from the patient's medical chart. Glycemic control will include: hemoglobin A1c (HbA1c, (%)), percent time in range (TIR - percentage of time in previous 14 days spent within target glucose range of 70-180 mg/dL or 3.9-10 mmol/L), and glucose management indicator (GMI, %).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start3 Apr 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Goldbloom, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979077
- Sponsor's protocol ID
- 22/99X
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hunter-Schouela J, Ure L, Zuijdwijk C, Abou-Assaly E, Ahmet A, de Boer J, Khatchadourian K, Kutcher SA, Lawrence SE, Reddy D, Webster R, Goldbloom EB. Evaluating Patient-Entered Electronic Health Data as a Strategy to Improve Quality of Care in a Diabetes Clinic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 8;15:e89519. doi: 10.2196/89519.
PubMed 42102260
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care in Diabetes Clinic Through Patient-Entered Electronic Health Data?
- ClinicalTrials.gov ID
- NCT05979077
- Acronym / sponsor ID
- 22/99X
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Aug 2023 (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.
Evolving technology and clinical innovation have led to dramatic changes in the management of type 1 diabetes (T1D). These changes have led to a need to collect a growing number of details from families during their visits. As a result, much of the physician-patient visit is spent transferring information instead of focusing on diabetes care, contributing to increased time pressures in clinic and unmet needs for patients.
In response to this reality, the investigators have developed a tool that allows families to input their diabetes-related information into their physicians' electronic health record (EHR) documentation tool before their clinic visit, using a questionnaire administered via CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes control and clinic efficiency. The investigators hope that our study will determine whether having families input clinical data prior to a visit is an effective strategy to improve the quality of diabetes care. The investigators believe that the findings will be of interest to all those studying the value of incorporating patient-entered data both within diabetes care and beyond.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyChart Questionnaire (Intervention Group) | Experimental | Other: MyChart QuestionnaireParticipants within the intervention group will complete the patient-facing EHR-enabled MyChart® questionnaire. |
| Standard Clinical Care (Control Group) | No intervention | –Participants within the control group will undergo standard clinical care with no study intervention. |
Who may qualify
- Ages
- 0 years to 131 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of T1D
- Age <11 years at enrollment
Key exclusion criteria (4 listed)
- Patients ≥ 11 years of age at enrollment
- Patients who are not fluent enough in English to complete all study related procedures
- Patients unable or unwilling to provide consent and/or assent
- Patients followed in Eating Disorder Clinic or Child and Youth Protection Clinic (there are MyChart activation restrictions for individuals followed in these clinics)
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 |
|---|---|---|
| MyChart QuestionnairePrior to clinic visits, families completing the MyChart Questionnaire will enter details about their current management and visit goals, automatically populating their electronic health record for subsequent review/revision by the health care team before and during the visit, reallocating clinic time previously used for data acquisition to individual patient priorities | Other | MyChart Questionnaire (Intervention Group) |
Primary outcome
To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care.
Time frame: 12 months
The EHR-enabled questionnaire will be completed through the online MyChart portal. Patients' parents are required to complete diabetes-related questions across a total of 10 pages, including questions regarding the visit, insulin dosing, injection dose, insulin delivery, blood sugar monitoring, high blood glucose and ketones, hypoglycemia, nutrition, physical activity, and general health. These questions are typically addressed during routine clinic visits; however, they will be completed prior to the clinic visit and automatically entered into the patient's medical chart.
Patients' Evaluation of Quality of Diabetes Care (PEQD)
Time frame: 12 months
The PEQD is a brief and validated questionnaire designed to assess the participants' judgement about the quality of their diabetes care. It is scored on a scale of 0-100 with 100 representing the best possible quality of care.
Perceived Quality of Medical Care (PQMC)
Time frame: 12 months
The PQMC is a validated instrument designed to provide a simple, general measure of patients' overall quality of medical care they receive. Alpha reliability estimates should be expected to be above .90 for this instrument. It is scored on a scale from 6-42, with lower scores representing better perceived quality of medical care.
Participant Tool and Workflow Survey
Time frame: 12 months
This study-specific questionnaire was developed during pilot work for this study and was designed to specifically assess the myChart questionnaire being completed before each clinic visit. This questionnaire will only be given to those participants randomized to the intervention group. While this questionnaire has not been validated, it has been used in previously published research by our study team.
1 secondary outcome
To evaluate the impact of a patient-facing EHR-enabled questionnaire on glycemic control and visit efficiency.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Derived from this study: PubMed 42102260Hunter-Schouela J, Ure L, Zuijdwijk C, Abou-Assaly E, Ahmet A, de Boer J, Khatchadourian K, Kutcher SA, Lawrence SE, Reddy D, Webster R, Goldbloom EB. Evaluating Patient-Entered Electronic Health Data as a Strategy to Improve Quality of Care in a Diabetes Clinic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 8;15:e89519. doi: 10.2196/89519.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyChart Questionnaire in people with Diabetes Mellitus, Type 1, run by Children's Hospital of Eastern Ontario 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
To evaluate the impact of a patient-facing EHR-enabled questionnaire on patient-perceived quality of care. (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05979077, which also lists 1 linked publication.
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 15 Apr 2025.