NCT03926598

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 6, 2023

Completed
Last Updated

January 6, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

April 10, 2019

Results QC Date

October 13, 2022

Last Update Submit

December 13, 2022

Conditions

Keywords

ObservationalMobile Applications

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 month

Study Arms (5)

Patients/Caretakers Group

Patients with Type II Diabetes and caretakers of patients with Type II Diabetes.

Behavioral: Patient and/or Family Member Intervention

Certified Diabetes Educators Group

Diabetes educators who help patients manage their Type II Diabetes.

Behavioral: Certified Diabetes Educator Intervention

Physician Group

Physicians who help patients manage their Type II Diabetes.

Behavioral: Physician Intervention

Front Desk Staff

Front desk staff who work with physicians that treat Type II Diabetes.

Behavioral: Front Desk Staff Intervention

Nurses

Nurses who help patients manage their Type II Diabetes.

Behavioral: Nurse Intervention

Interventions

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.

Patients/Caretakers Group

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.

Certified Diabetes Educators Group

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.

Physician Group

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.

Front Desk Staff

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.

Nurses

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Helathcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Related Publications (33)

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Related Links

Results Point of Contact

Title
Jiten Chhabra
Organization
Research Scientist

Study Officials

  • Jiten Chhabra, MD, MS

    Georgia Institute of Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 24, 2019

Study Start

June 5, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

January 6, 2023

Results First Posted

January 6, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations