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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926598
Recruitment Status : Completed
First Posted : April 24, 2019
Results First Posted : January 6, 2023
Last Update Posted : January 6, 2023
Sponsor:
Collaborators:
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Georgia Institute of Technology

Study Description
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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 Intervention/treatment
Type2 Diabetes Mellitus Behavioral: Patient and/or Family Member Intervention Behavioral: Certified Diabetes Educator Intervention Behavioral: Physician Intervention Behavioral: Front Desk Staff Intervention Behavioral: Nurse Intervention

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
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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 5, 2019
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926598


Locations
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United States, Georgia
Children's Helathcare of Atlanta
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Georgia Institute of Technology
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jiten Chhabra, MD, MS Georgia Institute of Technology
  Study Documents (Full-Text)

Documents provided by Georgia Institute of Technology:
Study Protocol  [PDF] December 13, 2022
Statistical Analysis Plan  [PDF] December 13, 2022
Informed Consent Form: Adult Consent Form  [PDF] April 1, 2020
Informed Consent Form: Minor Assent Form  [PDF] April 1, 2020
Informed Consent Form: Parental Permission Form  [PDF] April 1, 2020

More Information
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Additional Information:

Publications:
Alliance CC. Chronic Care Management - Five More Chronics. In: Outcomes Guidelines Report. Washington, D.C.; 2010:55-118.

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Responsible Party: Georgia Institute of Technology
ClinicalTrials.gov Identifier: NCT03926598    
Other Study ID Numbers: H18426
P30DK111024 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2019    Key Record Dates
Results First Posted: January 6, 2023
Last Update Posted: January 6, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Georgia Institute of Technology:
Observational
Mobile Applications
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases