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High Risk Youth With Poorly-controlled Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group education sessions
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring social media, noncompliance, youth, group education

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Between ages 13-18 (at the time of consent) with diagnosis of T1DM
  2. HbA1c >9% and/or episode of DKA within the past year (other than at diagnosis)
  3. Residence in a zip code associated with lower socioeconomic status (SES)
  4. Possession of a device capable of accessing online social media platforms

Exclusion criteria:

  1. Non-English speaking
  2. Diagnosed with a developmental or psychological condition that would prevent assumption of self-care responsibilities

Sites / Locations

  • St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Youth with type 1 diabetes

Arm Description

A group of 16 teens (ages 13-18) with poorly -controlled type 1 diabetes will be recruited to participate in this study.

Outcomes

Primary Outcome Measures

HbA1c
Measure of glycemic control

Secondary Outcome Measures

Diabetes self-management skills
Questionnaire (Self-Care Inventory--Revised Edition) to assess self-management skills prior to and after participation in this study. The questionnaire is a validated measure of perceptions of adherence to recommended diabetes self-care behaviors. There are a total of 15 questions, each with a number answer from a scale of "1" to "5". The lowest possible total score is 15, representing poor compliance with diabetes self-management skills, and the highest possible total score would be 75.
Improved quality of life
Peds QL Diabetes Module Version 3.0, Teen Report. This is a validated questionnaire to assess quality of life related to diabetes, this will be filled out at the start and after participation in this study. The questionnaire consists of 28 questions with answers from a scale of "0" to "4" with higher scores representing lower quality of life.
Number of hospital admissions for DKA
Measure of severe diabetes episodes
Depression screening
The PHQ-2 depression questionnaire is a validated 2 question screen for depression. Each question has an answer scale from "0" to "3". A score of 3 or more (highest score would be 6) is a positive screen for depression. This questionnaire will be given to participants at the start and after participation in this study.

Full Information

First Posted
September 10, 2018
Last Updated
September 20, 2019
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03680079
Brief Title
High Risk Youth With Poorly-controlled Diabetes
Official Title
Group Education Program for High-risk Youth With Poorly-controlled Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to implement a group education curriculum integrated with social media participation to provide peer support and interactive education sessions with the goal of improving glycemic control in disadvantaged youth with poorly-controlled type 1 diabetes.
Detailed Description
It has been well established through The Diabetes Control and Complications Trial (DCCT) and its follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) studies that achieving lower hemoglobin A1c (HbA1c) levels are associated with the delay and prevention of long-term complications of T1DM (1, 2). Management of T1DM involves adherence to a complex, labor-intensive regimen of subcutaneous insulin treatment, close glucose monitoring, accurate calculation of carbohydrate intake, and adjustment of dosing and dietary regimen to account for physical activity. Recent technological advances including insulin pumps with auto-insulin-adjusting features along with continuous glucose monitoring systems have allowed for individuals with T1DM to achieve tighter diabetes control. However, despite these advances in glucose monitoring and insulin delivery systems, the majority of children and adolescents fail to optimize their diabetes control and are unable to achieve these targets. Several studies have shown that adolescents in poor diabetes control are more likely to come from a racial minority background, have lower annual household income, and be publicly insured. In addition, these patients are also more likely to have missed medical appointments and have less stable home environments. Thus, increased efforts and innovative programs are needed to overcome additional barriers faced by youth with T1DM from disadvantaged backgrounds with the goal of improving the delivery of diabetes care for our most vulnerable, at-risk youth population. The objective of this pilot and feasibility project is to implement a clinic-based group education program targeting teens with poorly controlled diabetes, focusing on peer group interaction and education combined with social media support to increase engagement and promote behavioral change to improve glycemic control. This study utilizes 1) group education sessions (6 total sessions over the course of 9 months), 2) online social media group forums, 3) questionnaires to assess self-care habits in diabetes management and quality of life, and 4) surveys to assess this program. Patients will be included in closed, private Facebook, Snapchat, and Instagram groups where members can communicate with each other and where biweekly updates, reminders, and messages of encouragement relevant to the previous topic covered at group sessions can be sent to the group. Online group forums will be moderated by a staff member to ensure that message content is appropriate and to avoid misinformation or questionable patient-to-patient medical advice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
social media, noncompliance, youth, group education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The intervention being studied is a group education program
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Youth with type 1 diabetes
Arm Type
Other
Arm Description
A group of 16 teens (ages 13-18) with poorly -controlled type 1 diabetes will be recruited to participate in this study.
Intervention Type
Other
Intervention Name(s)
Group education sessions
Other Intervention Name(s)
Social media peer support
Intervention Description
Peer support and interaction both in-person during group education sessions and online via social media platforms
Primary Outcome Measure Information:
Title
HbA1c
Description
Measure of glycemic control
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diabetes self-management skills
Description
Questionnaire (Self-Care Inventory--Revised Edition) to assess self-management skills prior to and after participation in this study. The questionnaire is a validated measure of perceptions of adherence to recommended diabetes self-care behaviors. There are a total of 15 questions, each with a number answer from a scale of "1" to "5". The lowest possible total score is 15, representing poor compliance with diabetes self-management skills, and the highest possible total score would be 75.
Time Frame
9 months
Title
Improved quality of life
Description
Peds QL Diabetes Module Version 3.0, Teen Report. This is a validated questionnaire to assess quality of life related to diabetes, this will be filled out at the start and after participation in this study. The questionnaire consists of 28 questions with answers from a scale of "0" to "4" with higher scores representing lower quality of life.
Time Frame
9 months
Title
Number of hospital admissions for DKA
Description
Measure of severe diabetes episodes
Time Frame
12 months
Title
Depression screening
Description
The PHQ-2 depression questionnaire is a validated 2 question screen for depression. Each question has an answer scale from "0" to "3". A score of 3 or more (highest score would be 6) is a positive screen for depression. This questionnaire will be given to participants at the start and after participation in this study.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between ages 13-18 (at the time of consent) with diagnosis of T1DM HbA1c >9% and/or episode of DKA within the past year (other than at diagnosis) Residence in a zip code associated with lower socioeconomic status (SES) Possession of a device capable of accessing online social media platforms Exclusion criteria: Non-English speaking Diagnosed with a developmental or psychological condition that would prevent assumption of self-care responsibilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Kim, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25043685
Citation
DCCT/EDIC research group. Effect of intensive diabetes treatment on albuminuria in type 1 diabetes: long-term follow-up of the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications study. Lancet Diabetes Endocrinol. 2014 Oct;2(10):793-800. doi: 10.1016/S2213-8587(14)70155-X. Epub 2014 Jul 17.
Results Reference
background
PubMed Identifier
26861924
Citation
Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Intensive Diabetes Treatment and Cardiovascular Outcomes in Type 1 Diabetes: The DCCT/EDIC Study 30-Year Follow-up. Diabetes Care. 2016 May;39(5):686-93. doi: 10.2337/dc15-1990. Epub 2016 Feb 9.
Results Reference
background
PubMed Identifier
23957219
Citation
Campbell MS, Schatz DA, Chen V, Wong JC, Steck A, Tamborlane WV, Smith J, Beck RW, Cengiz E, Laffel LM, Miller KM, Haller MJ; T1D Exchange Clinic Network. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes. 2014 Mar;15(2):110-7. doi: 10.1111/pedi.12067. Epub 2013 Aug 19.
Results Reference
background
PubMed Identifier
26802317
Citation
Khanolkar AR, Amin R, Taylor-Robinson D, Viner RM, Warner JT, Stephenson T. Young people with Type 1 diabetes of non-white ethnicity and lower socio-economic status have poorer glycaemic control in England and Wales. Diabet Med. 2016 Nov;33(11):1508-1515. doi: 10.1111/dme.13079. Epub 2016 Feb 23.
Results Reference
background
PubMed Identifier
26559135
Citation
Fortin K, Pries E, Kwon S. Missed Medical Appointments and Disease Control in Children With Type 1 Diabetes. J Pediatr Health Care. 2016 Jul-Aug;30(4):381-9. doi: 10.1016/j.pedhc.2015.09.012. Epub 2015 Nov 7.
Results Reference
background

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High Risk Youth With Poorly-controlled Diabetes

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