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Completed

NCT Number: NCT03436628

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Adolescent Behavior Autoimmune Diseases Behavior Communication Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Parent-Child Relations

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MyT1DHero

Device

A mobile phone application

Primary outcomes

  1. Change in Adherence to Self-management

    Time frame: Baseline and 3 months

    Measured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome

  2. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline and 3 months

    A laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome

Secondary outcomes

  1. Change in Social Support

    Time frame: Baseline and 3 months

    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

  2. Change in Self-Efficacy

    Time frame: Baseline and 3 months

    Measured using Diabetes Empowerment Scale - Short Form (5-point likert scale, strongly disagree-strongly agree); A higher value represents a better outcome

  3. Change in Quality of Life

    Time frame: Baseline and 3 months

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

  4. Change in Conflict

    Time frame: Baseline and 3 months

    Measured using Diabetes Family Conflict Scale (3-point likert scale, always-never); A lower value represents a better outcome

  5. Parenting

    Time frame: Baseline

    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.

  6. Change in Parental Monitoring

    Time frame: Baseline and 3 months

    Measured using Parental Monitoring of Diabetes Care Scale (5-point likert scale, always-never); A lower value represents a better outcome

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Sparrow Health System

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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