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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436628
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Sparrow Health System
Information provided by (Responsible Party):
Bree Holtz, Michigan State University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Adolescent Behavior Parent-Child Relations Communication Device: MyT1DHero Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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
A mobile phone application




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).


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): NCT03436628


Locations
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United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
Sparrow Health System
Investigators
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Principal Investigator: Bree M Holtz, PhD Michigan State University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bree Holtz, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT03436628    
Other Study ID Numbers: MyT1DHero
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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
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