Trial Outcomes & Findings for Guide To Goals: A Novel Care Coordination Tool for Children With Type Two Diabetes (T2D) (NCT NCT03926598)
NCT ID: NCT03926598
Last Updated: 2023-01-06
Results Overview
Number of participants that complete all the tasks assigned to them during the intervention (usability testing session).
Recruitment status
COMPLETED
Target enrollment
6 participants
Primary outcome timeframe
1 month
Results posted on
2023-01-06
Participant Flow
Recruitment occurred in the following sequence of events: 1. Members of Dr. Andrew Muir's staff at CHOA described the study to potential participants during regular office visits. 2. Individuals interested in participating in the study then schedules a time to meet with a member of the study team at CHOA and consented to be part of the study.
Participant milestones
| Measure |
Patients/Caretakers Group
Patients with Type II Diabetes and caretakers of patients with Type II Diabetes.
Patient and/or Family Member Intervention: On the Patient Login Screen, log in using your last name and session ID provided by the research team on the Surveys Screen, click on a pending survey when the survey opens, respond to the survey submit the survey log out of the Guide-Goals Application.
|
Certified Diabetes Educators Group
Diabetes educators who help patients manage their Type II Diabetes.
Certified Diabetes Educator Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
|
Physician Group
Physicians who help patients manage their Type II Diabetes.
Physician Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patient Screen, add a new patient on the Edit Patient Screen, add the Diabetes Family Responsibility Questionnaire on the Edit Patient Screen, create a survey access code to share with the patient.
|
Front Desk Staff
Front desk staff who work with physicians that treat Type II Diabetes.
Front Desk Staff Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
|
Nurses
Nurses who help patients manage their Type II Diabetes.
Nurse Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status screen, change HbA1C value to 10% on the Visit Status screen, change Nephropathy evaluation to Abnormal log out of Guide to Goals application.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
0
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Guide To Goals: A Novel Care Coordination Tool for Children With Type Two Diabetes (T2D)
Baseline characteristics by cohort
| Measure |
Patients/Caretakers Group
n=1 Participants
Patients with Type II Diabetes and caretakers of patients with Type II Diabetes.
Patient and/or Family Member Intervention: On the Patient Login Screen, log in using your last name and session ID provided by the research team on the Surveys Screen, click on a pending survey when the survey opens, respond to the survey submit the survey log out of the Guide-Goals Application.
|
Certified Diabetes Educators Group
n=1 Participants
Diabetes educators who help patients manage their Type II Diabetes.
Certified Diabetes Educator Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
|
Physician Group
Physicians who help patients manage their Type II Diabetes.
Physician Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patient Screen, add a new patient on the Edit Patient Screen, add the Diabetes Family Responsibility Questionnaire on the Edit Patient Screen, create a survey access code to share with the patient.
|
Front Desk Staff
n=2 Participants
Front desk staff who work with physicians that treat Type II Diabetes.
Front Desk Staff Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
|
Nurses
n=2 Participants
Nurses who help patients manage their Type II Diabetes.
Nurse Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status screen, change HbA1C value to 10% on the Visit Status screen, change Nephropathy evaluation to Abnormal log out of Guide to Goals application.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Recruitment incomplete due to COVID-19
Number of participants that complete all the tasks assigned to them during the intervention (usability testing session).
Outcome measures
| Measure |
Patients/Caretakers Group
n=1 Participants
Patients with Type II Diabetes and caretakers of patients with Type II Diabetes.
Patient and/or Family Member Intervention: On the Patient Login Screen, log in using your last name and session ID provided by the research team on the Surveys Screen, click on a pending survey when the survey opens, respond to the survey submit the survey log out of the Guide-Goals Application.
|
Certified Diabetes Educators Group
n=1 Participants
Diabetes educators who help patients manage their Type II Diabetes.
Certified Diabetes Educator Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
|
Physician Group
Physicians who help patients manage their Type II Diabetes.
Physician Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patient Screen, add a new patient on the Edit Patient Screen, add the Diabetes Family Responsibility Questionnaire on the Edit Patient Screen, create a survey access code to share with the patient.
|
Front Desk Staff
n=2 Participants
Front desk staff who work with physicians that treat Type II Diabetes.
Front Desk Staff Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
|
Nurses
n=2 Participants
Nurses who help patients manage their Type II Diabetes.
Nurse Intervention: On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status screen, change HbA1C value to 10% on the Visit Status screen, change Nephropathy evaluation to Abnormal log out of Guide to Goals application.
|
|---|---|---|---|---|---|
|
Participant Task Completion Rate for Usability Testing Session
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Patients/Caretakers Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Certified Diabetes Educators Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physician Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Front Desk Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nurses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place