Type2 Diabetes Mellitus
Conditions
Keywords
Observational, Mobile Applications
Brief summary
The ultimate goal of this field trial is to systematically evaluate a novel care coordination tool for children with Type 2 Diabetes (T2D) in an office setting at Emory/Childrens Healthcare of Atlanta. The Guide to Goals (GTG) application was designed and developed at Georgia Institute of Technology with the aim of providing evidence-based information in a timely manner to all the stakeholders involved in the care of a T2D patient during an office visit
Detailed description
The purpose of this project is to evaluate the user interface of GTG for ease-of-use. By observing and analyzing actual user experience with the current version of the app investigators aim to learn about its shortcomings. Findings from this phase will be used to make GTG more user friendly. GTG is aimed at the following user groups: 1. Patients/caretakers 2. Font-desk staff 3. Nurses 4. Certified Diabetes Educators 5. Physicians In this phase, two participants will be recruited from each of the five user groups for a one-hour usability testing session during which time they will be subjected to the following: A. Introduction to study team and session procedures with the help of a physical consent form (15 minutes) B. Perform a set of tasks on the GTG application (15 minutes) C. Post task interview with study team (15 minutes) D. Fill out post-interview questionnaire (15 minutes) The specific set of tasks that each participants will perform during the usability testing session will be: 1. Front Desk Staff: 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. 2. Patient and/or Family Member: On the Patient Login Screen, log in using the 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. 3. Nurse: 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. 4. Certified Diabetes Educator: On the Provider Login Screen, log in using the participant's 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. 5. Physician: 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 review planning and accountability sections for errors on the Visit Status Screen, add a goal for the patient log out of Goals- to-Guide application.
Interventions
BEHAVIORALPatient 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.
BEHAVIORALCertified 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.
BEHAVIORALPhysician 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.
BEHAVIORALFront 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.
BEHAVIORALNurse 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.
Sponsors
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Georgia Institute of Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Existing patients of Children's Healthcare of Atlanta (CHOA) with Type 2 Diabetes that are 12 or older at the time of participation or caretakers of existing patients of CHOA with Type 2 Diabetes * Front desk staff * Nurses at CHOA * Certified Diabetes Educators at CHOA * Physicians working at CHOA * Participants must also be fluent in English, either as a first or secondary language, as the Guide-To-Goals app is in English.
Exclusion criteria
* Individuals that are using a care coordination tool other than GTG to translate ADA clinical standards of care for children with T2D during the study period will be excluded from this study in order to avoid confounding factors. Examples of care coordination tools include products that have the capabilities to send and receive electronic messages to the care team, receive and discuss care plans, and create and share health logs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Task Completion Rate for Usability Testing Session | 1 month | Number of participants that complete all the tasks assigned to them during the intervention (usability testing session). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 1 |
| 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. | 0 |
| 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. | 2 |
| 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. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Certified Diabetes Educators Group | Physician Group | Front Desk Staff | Nurses | Total | Patients/Caretakers Group |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | — | 2 participants | 2 participants | 6 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 0 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 0 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 0 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Participant Task Completion Rate for Usability Testing Session
Number of participants that complete all the tasks assigned to them during the intervention (usability testing session).
Time frame: 1 month
Population: Recruitment incomplete due to COVID-19
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients/Caretakers Group | Participant Task Completion Rate for Usability Testing Session | 1 Participants |
| Certified Diabetes Educators Group | Participant Task Completion Rate for Usability Testing Session | 1 Participants |
| Physician Group | Participant Task Completion Rate for Usability Testing Session | 0 Participants |
| Front Desk Staff | Participant Task Completion Rate for Usability Testing Session | 2 Participants |
| Nurses | Participant Task Completion Rate for Usability Testing Session | 2 Participants |