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CompletedNCT03436628Updated Oct 19, 2020

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

An interventional study of MyT1DHero in Type 1 Diabetes Mellitus, Adolescent Behavior and Parent-Child Relations, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Michigan State University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
10 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus
  • Adolescent Behavior
  • Parent-Child Relations
  • Communication
03

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    App Use

    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.

    Device: MyT1DHero

Interventions

  • DeviceMyT1DHero

    A mobile phone application

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and 3 months

  2. Change in Hemoglobin A1c (HbA1c)

    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 outcomes

  1. 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

    Time frame: Baseline and 3 months

  2. 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

    Time frame: Baseline and 3 months

  3. Change in Quality of Life

    Measured using PedsQL (5-point likert scale, never-almost always); A higher value represents a better outcome

    Time frame: Baseline and 3 months

  4. Change in Conflict

    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

  5. 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.

    Time frame: Baseline

  6. 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

    Time frame: Baseline and 3 months

06

Study locations

1 site
  • Michigan State University
    East Lansing, Michigan 48824, United States
07

References and documents

Publications

  • 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. PubMed 34519670 ↗
  • 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. PubMed 30377142 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03436628
Lead sponsor
Michigan State University
Collaborators
Sparrow Health System
Responsible party
Bree Holtz (Assistant Professor, Michigan State University) — Principal investigator
First posted
Feb 19, 2018
Start date
Mar 1, 2018
Primary completion
Jul 31, 2019
Completion
Dec 31, 2019
Last update
Oct 19, 2020

Study contacts

Bree M Holtz, PhD
principal investigator · Michigan State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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