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Social Media Use in Adolescent Diabetes Care

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Media
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

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

Inclusion Criteria: Diagnosed with type 1 diabetes ≥12 months Most recent HbA1c level is > 7.0% Currently use Dexcom CGM device Speak English fluently Cognitively able to participate in program on Instagram and complete surveys Have access to a personal Instagram account Found to be eligible on the Social Media Preference Screener Exclusion Criteria: Patient is a ward of the state Patient is pregnant as diabetes standard of care is different during pregnancy (i.e., different glycemic targets and frequency of clinic visits) Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes

Sites / Locations

  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Social Media Intervention

Usual Care

Arm Description

In addition to receiving usual care, participants enrolled in the social media arm will receive diabetes education and support over the course of 6 months by following the study team's Instagram page and engaging with the study team and other adolescent participants on Instagram.

Usual care reflects the standard treatment currently provided to adolescents living with type 1 diabetes. Every adolescent with diabetes is cared for by a team of diabetes specialists which includes a provider (MD, Physician Assistant and/or Nurse Practitioner), registered nurse, nutritionist and social worker. Adolescents with type 1 diabetes are seen by their multidisciplinary team approximately every 3 months. In addition, they have access to their multidisciplinary care team via telephone and/or MyChart communication as often as is necessary between clinic visits.

Outcomes

Primary Outcome Measures

Feasibility: Enrollment
Percentage of participants who enroll in study after in-person or remote discussion about study participation.
Feasibility: Retention Rate
Percentage of enrolled participants who complete the final 6-month surveys.

Secondary Outcome Measures

HbA1c
HbA1c laboratory measurements collected during the intervention.
Time In Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL).
Time Above Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).
Time Below Range
Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).
Diabetes Self-Management
Adherence will be assessed with the Diabetes Self-Management Questionnaire. Higher scores indicate higher adherence to diabetes self-management.
Diabetes Distress
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress.
Diabetes Family Conflict
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict.
Health Care Transition Readiness
Health care transition readiness will be assessed with the Readiness Assessment in Emerging Adults with Type 1 Diabetes Diagnosed in Youth. Higher scores indicate higher health care transition readiness.
Depressive Symptoms
Depressive symptoms will be assessed with the Patient Health Questionnaire-8. Higher scores indicate higher depressive symptoms.
Mental Wellbeing
Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale. Higher scores indicate higher mental wellbeing.
Problematic Internet Use
Adolescent problematic internet use will be assessed with the Problematic and Risky Internet Use Screening Scale. Higher scores indicate higher concern for problematic internet use.
Diabetes Strengths
Adolescents' diabetes-specific "strengths" (i.e., positive behaviors and attitudes related to the challenges of living with type 1 diabetes) will be assessed with the Diabetes Strengths and Resilience measure. Higher scores indicate increased diabetes-specific strengths.
Diabetes Quality of Life
Diabetes-specific quality of life will be assessed using the adolescent self-report version of the Type 1 Diabetes and Life. Higher scores indicate higher diabetes-specific quality of life.
Screen Time
Screen time use will be measured by the Screen Time summary from a participant's smartphone device.

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06085339
Brief Title
Social Media Use in Adolescent Diabetes Care
Official Title
Social Media Use in Adolescent Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the feasibility of a social media intervention to support diabetes management in adolescents with type 1 diabetes. Adolescent participants will be randomized to receive diabetes education and peer support over Instagram or to usual outpatient diabetes care. Researchers will assess whether the social media intervention is feasible. In addition, the study team will also explore and compare changes in glucose levels and person-reported outcomes between the two groups.
Detailed Description
The majority of adolescents with type 1 diabetes do not meet recommended glycemic targets, placing them at risk for acute and chronic diabetes-related complications. Strategies that improve adolescent diabetes self-management are needed. Social media offers new opportunities to provide diabetes education and peer support through communication in a digital environment. As part of a randomized controlled trial, adolescent participants will be randomized to receive diabetes education and peer support over Instagram in addition to usual care or to standard outpatient diabetes care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Media Intervention
Arm Type
Experimental
Arm Description
In addition to receiving usual care, participants enrolled in the social media arm will receive diabetes education and support over the course of 6 months by following the study team's Instagram page and engaging with the study team and other adolescent participants on Instagram.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care reflects the standard treatment currently provided to adolescents living with type 1 diabetes. Every adolescent with diabetes is cared for by a team of diabetes specialists which includes a provider (MD, Physician Assistant and/or Nurse Practitioner), registered nurse, nutritionist and social worker. Adolescents with type 1 diabetes are seen by their multidisciplinary team approximately every 3 months. In addition, they have access to their multidisciplinary care team via telephone and/or MyChart communication as often as is necessary between clinic visits.
Intervention Type
Behavioral
Intervention Name(s)
Social Media
Intervention Description
The Social Media Arm participants will receive a diabetes curriculum designed to address diabetes self-efficacy and independence with diabetes management over the course of 6 months. Participants will have the option to engage with the study team and other participants through Instagram posts and direct messaging.
Primary Outcome Measure Information:
Title
Feasibility: Enrollment
Description
Percentage of participants who enroll in study after in-person or remote discussion about study participation.
Time Frame
0 months
Title
Feasibility: Retention Rate
Description
Percentage of enrolled participants who complete the final 6-month surveys.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HbA1c
Description
HbA1c laboratory measurements collected during the intervention.
Time Frame
Change over 6 months
Title
Time In Range
Description
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL).
Time Frame
Change over 6 months
Title
Time Above Range
Description
Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).
Time Frame
Change over 6 months
Title
Time Below Range
Description
Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).
Time Frame
Change over 6 months
Title
Diabetes Self-Management
Description
Adherence will be assessed with the Diabetes Self-Management Questionnaire. Higher scores indicate higher adherence to diabetes self-management.
Time Frame
Change over 6 months
Title
Diabetes Distress
Description
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress.
Time Frame
Change over 6 months
Title
Diabetes Family Conflict
Description
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict.
Time Frame
Change over 6 months
Title
Health Care Transition Readiness
Description
Health care transition readiness will be assessed with the Readiness Assessment in Emerging Adults with Type 1 Diabetes Diagnosed in Youth. Higher scores indicate higher health care transition readiness.
Time Frame
Change over 6 months
Title
Depressive Symptoms
Description
Depressive symptoms will be assessed with the Patient Health Questionnaire-8. Higher scores indicate higher depressive symptoms.
Time Frame
Change over 6 months
Title
Mental Wellbeing
Description
Mental wellbeing will be assessed with the Warwick-Edinburgh Mental Wellbeing Scale. Higher scores indicate higher mental wellbeing.
Time Frame
Change over 6 months
Title
Problematic Internet Use
Description
Adolescent problematic internet use will be assessed with the Problematic and Risky Internet Use Screening Scale. Higher scores indicate higher concern for problematic internet use.
Time Frame
Change over 6 months
Title
Diabetes Strengths
Description
Adolescents' diabetes-specific "strengths" (i.e., positive behaviors and attitudes related to the challenges of living with type 1 diabetes) will be assessed with the Diabetes Strengths and Resilience measure. Higher scores indicate increased diabetes-specific strengths.
Time Frame
Change over 6 months
Title
Diabetes Quality of Life
Description
Diabetes-specific quality of life will be assessed using the adolescent self-report version of the Type 1 Diabetes and Life. Higher scores indicate higher diabetes-specific quality of life.
Time Frame
Change over 6 months
Title
Screen Time
Description
Screen time use will be measured by the Screen Time summary from a participant's smartphone device.
Time Frame
Change over 6 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: Diagnosed with type 1 diabetes ≥12 months Most recent HbA1c level is > 7.0% Currently use Dexcom CGM device Speak English fluently Cognitively able to participate in program on Instagram and complete surveys Have access to a personal Instagram account Found to be eligible on the Social Media Preference Screener Exclusion Criteria: Patient is a ward of the state Patient is pregnant as diabetes standard of care is different during pregnancy (i.e., different glycemic targets and frequency of clinic visits) Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faisal S Malik, MD, MSHS
Phone
206-987-0121
Email
faisal.malik@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal S Malik, MD, MSHS
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faisal S Malik, MD, MSHS
Phone
206-987-0121
Email
faisal.malik@seattlechildrens.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Social Media Use in Adolescent Diabetes Care

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