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

December 13, 2022 updated by: Georgia Institute of Technology

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Helathcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Task Completion Rate for Usability Testing Session
Time Frame: 1 month
Number of participants that complete all the tasks assigned to them during the intervention (usability testing session).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgia Institute of Technology

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H18426
  • P30DK111024 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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