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

NCT03436628 | Completed

• 1 other identifier: MyT1DHero
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Adolescent Behavior; Parent-Child Relations; Communication

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline and 3 months

• Change in Hemoglobin A1c (HbA1c)

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

  Baseline and 3 months

Secondary Outcomes (6)

• Change in Social Support

  Baseline and 3 months

• Change in Self-Efficacy

  Baseline and 3 months

• Change in Quality of Life

  Baseline and 3 months

• Change in Conflict

  Baseline and 3 months

• Parenting

  Baseline

Study Arms (1)

App Use

EXPERIMENTAL

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

MyT1DHero DEVICE

A mobile phone application

App Use

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead
• Sparrow Health System: collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (2)

• 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.

  PMID: 34519670 DERIVED

• 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.

  PMID: 30377142 DERIVED

Related Links

• Study Information Website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Adolescent Behavior; Communication

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Bree M Holtz, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)