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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Guide To Goals: A Novel Care Coordination Tool for Children With Type Two Diabetes (T2D)

Clinicaltrials.gov identifier NCT03926598

Recruitment Status Terminated (This study did not complete enrollment due to COVID-19. Institutional constraints prevented this study from continuing and the study team no longer wishes to pursue this project.)

First Posted April 24, 2019

Last update posted January 7, 2021

Study Description

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

  • Condition or Disease:Type2 Diabetes Mellitus
  • Intervention/Treatment: Behavioral: Patient and/or Family Member Intervention
    Behavioral: Certified Diabetes Educator Intervention
    Behavioral: Physician Intervention
    Behavioral: Front Desk Staff Intervention
    Behavioral: Nurse Intervention
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 6 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: User Evaluation of the Guide To Goals Application - a Care Coordination Tool to Translate ADA Clinical Standards of Care for Children With T2D Into Practice
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: August 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Patients/Caretakers Group
Patients with Type II Diabetes and caretakers of patients with Type II Diabetes.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Outcome Measures
  • Primary Outcome Measures: 1. Participant Task Completion Rate for Usability Testing Session [ Time Frame: 3 months ]
    Number of participants that complete all the tasks assigned to them during the intervention (usability testing session).
Eligibility Criteria
  • Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Individuals participating in the usability testing session must be one the following: 1. 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 2. Front desk staff 3. Nurses at CHOA 4. Certified Diabetes Educators at CHOA 5. 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.
Criteria

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.

Contacts and Locations
Contacts
Locations

United States, Georgia
Children's Helathcare of Atlanta
Atlanta

Sponsors and Collaborators

Georgia Institute of Technology

Emory University

Investigators

Principal Investigator: Jiten Chhabra, MD, MS Georgia Institute of Technology

More Information