search
Back to results

Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens

Primary Purpose

Type 1 Diabetes Mellitus, Adolescent Behavior, Parent-Child Relations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyT1DHero
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes Mellitus

Eligibility Criteria

10 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The adolescents must:

  1. have a T1D diagnosis according to the ADA practice guidelines;
  2. be 10 to 15 years old;
  3. have had a diagnosis of T1D for at least six months;
  4. have an A1c > 7;97
  5. have had at least two outpatient visits in the past two years;
  6. be treated at Sparrow for diabetes;
  7. be fluent in English;
  8. have a parent/guardian willing to participate;
  9. be allowed to use a mobile phone for the study;
  10. have permission from their care team.

The parent/guardian must:

  1. have an adolescent with T1D who is 10 to 15 years old;
  2. be fluent in English;
  3. have daily access to email and the Internet (for appointment reminders and technical support).

Exclusion Criteria:

The exclusions for adolescents include:

  1. significant medical conditions other than T1D;
  2. being treated for thyroid disorders, celiac disease, or eating disorders;
  3. being in foster care.

Exclusion criteria for both the adolescents and parents/guardians include:

a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and mental retardation).

Sites / Locations

  • Michigan State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

App Use

Arm Description

Kids (10-15 years old) with type 1 diabetes and one of their parents will receive the MyT1DHero app to use for a 3-month period. Participants are urged to use the app four times each day.

Outcomes

Primary Outcome Measures

Change in Adherence to Self-management
Measured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome
Change in Hemoglobin A1c (HbA1c)
A laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome

Secondary Outcome Measures

Change in Social Support
Measured with the Multidimensional Scale of Perceived Social Support (5 point likert scale, all of the time-never); A lower value represents a better outcome
Change in Self-Efficacy
Measured using Diabetes Empowerment Scale - Short Form (5-point likert scale, strongly disagree-strongly agree); A higher value represents a better outcome
Change in Quality of Life
Measured using PedsQL (5-point likert scale, never-almost always); A higher value represents a better outcome
Change in Conflict
Measured using Diabetes Family Conflict Scale (3-point likert scale, always-never); A lower value represents a better outcome
Parenting
Measured using Alabama Parenting Questionnaire (5-point likert scale, very often-never); Values of this scale vary based on which sub scale is being used. For negative parenting sub scales, a lower value represents a better outcome; and for positive parenting sub scales, a higher value represents a better outcome.
Change in Parental Monitoring
Measured using Parental Monitoring of Diabetes Care Scale (5-point likert scale, always-never); A lower value represents a better outcome

Full Information

First Posted
February 5, 2018
Last Updated
October 15, 2020
Sponsor
Michigan State University
Collaborators
Sparrow Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT03436628
Brief Title
Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens
Official Title
Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Sparrow Health System

4. Oversight

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

5. Study Description

Brief Summary
Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age; their parents have to manage their child's condition. Eventually, the child must begin to take steps to transition to self-management. During the transition from parent to adolescent self-management, difficulties arise because adolescents may not be fully aware of, or want, to take responsibility for all the necessary tasks to successfully manage their T1D. Though there are other apps on the market to help with diabetes care, NONE do what the proposed app will do. The proposed self-management mobile app allows for monitoring the patients' T1D by linking their self-management information to their parents' cell phone, and thus also helps to bridge communication gaps. Prior research suggests that these are critical gaps that must be filled in order for successful transition in care to occur, the proposed app will help fill some of these gaps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Adolescent Behavior, Parent-Child Relations, Communication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App Use
Arm Type
Experimental
Arm Description
Kids (10-15 years old) with type 1 diabetes and one of their parents will receive the MyT1DHero app to use for a 3-month period. Participants are urged to use the app four times each day.
Intervention Type
Device
Intervention Name(s)
MyT1DHero
Intervention Description
A mobile phone application
Primary Outcome Measure Information:
Title
Change in Adherence to Self-management
Description
Measured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome
Time Frame
Baseline and 3 months
Title
Change in Hemoglobin A1c (HbA1c)
Description
A laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in Social Support
Description
Measured with the Multidimensional Scale of Perceived Social Support (5 point likert scale, all of the time-never); A lower value represents a better outcome
Time Frame
Baseline and 3 months
Title
Change in Self-Efficacy
Description
Measured using Diabetes Empowerment Scale - Short Form (5-point likert scale, strongly disagree-strongly agree); A higher value represents a better outcome
Time Frame
Baseline and 3 months
Title
Change in Quality of Life
Description
Measured using PedsQL (5-point likert scale, never-almost always); A higher value represents a better outcome
Time Frame
Baseline and 3 months
Title
Change in Conflict
Description
Measured using Diabetes Family Conflict Scale (3-point likert scale, always-never); A lower value represents a better outcome
Time Frame
Baseline and 3 months
Title
Parenting
Description
Measured using Alabama Parenting Questionnaire (5-point likert scale, very often-never); Values of this scale vary based on which sub scale is being used. For negative parenting sub scales, a lower value represents a better outcome; and for positive parenting sub scales, a higher value represents a better outcome.
Time Frame
Baseline
Title
Change in Parental Monitoring
Description
Measured using Parental Monitoring of Diabetes Care Scale (5-point likert scale, always-never); A lower value represents a better outcome
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The adolescents must: have a T1D diagnosis according to the ADA practice guidelines; be 10 to 15 years old; have had a diagnosis of T1D for at least six months; have an A1c > 7;97 have had at least two outpatient visits in the past two years; be treated at Sparrow for diabetes; be fluent in English; have a parent/guardian willing to participate; be allowed to use a mobile phone for the study; have permission from their care team. The parent/guardian must: have an adolescent with T1D who is 10 to 15 years old; be fluent in English; have daily access to email and the Internet (for appointment reminders and technical support). Exclusion Criteria: The exclusions for adolescents include: significant medical conditions other than T1D; being treated for thyroid disorders, celiac disease, or eating disorders; being in foster care. Exclusion criteria for both the adolescents and parents/guardians include: a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and mental retardation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bree M Holtz, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34519670
Citation
Holtz B, Mitchell KM, Holmstrom AJ, Cotten SR, Dunneback JK, Jimenez-Vega J, Ellis DA, Wood MA. An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study. JMIR Mhealth Uhealth. 2021 Sep 14;9(9):e23916. doi: 10.2196/23916.
Results Reference
derived
PubMed Identifier
30377142
Citation
Holtz BE, Mitchell KM, Hershey DD, Cotten SR, Holmstrom AJ, Richman J, Dunneback JK, Wood MA. Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study. JMIR Res Protoc. 2018 Oct 30;7(10):e10803. doi: 10.2196/10803.
Results Reference
derived
Links:
URL
http://myt1d.org
Description
Study Information Website

Learn more about this trial

Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens

We'll reach out to this number within 24 hrs