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High Risk Youth With Poorly-controlled Diabetes

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ClinicalTrials.gov Identifier: NCT03680079
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Group education sessions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The intervention being studied is a group education program
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Group Education Program for High-risk Youth With Poorly-controlled Type 1 Diabetes
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Youth with type 1 diabetes
A group of 16 teens (ages 13-18) with poorly -controlled type 1 diabetes will be recruited to participate in this study.
Other: Group education sessions
Peer support and interaction both in-person during group education sessions and online via social media platforms
Other Name: Social media peer support




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 months ]
    Measure of glycemic control


Secondary Outcome Measures :
  1. Diabetes self-management skills [ Time Frame: 9 months ]

    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.


  2. Improved quality of life [ Time Frame: 9 months ]
    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.

  3. Number of hospital admissions for DKA [ Time Frame: 12 months ]
    Measure of severe diabetes episodes

  4. Depression screening [ Time Frame: 9 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03680079


Contacts
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Contact: Ellen Kim, MD 314-454-6051 eekim@wustl.edu
Contact: Pamela Stone 314-454-4659 stone.p@wustl.edu

Locations
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United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ellen Kim, MD    314-454-6051    eekim@wustl.edu   
Contact: Pamela Stone    314-454-4659    stone.p@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ellen Kim, MD Washington University School of Medicine

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03680079     History of Changes
Other Study ID Numbers: 201807091
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
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

Keywords provided by Washington University School of Medicine:
social media
noncompliance
youth
group education

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases