Clinical trial NCT03436628: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Adolescent Behavior
Parent-Child Relations
Communication
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Sparrow Health System
First posted: 2018-02-19
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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).

Primary outcomes:
measure: Change in Adherence to Self-management
timeFrame: Baseline and 3 months
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Social Support
timeFrame: Baseline and 3 months
measure: Change in Self-Efficacy
timeFrame: Baseline and 3 months
measure: Change in Quality of Life
timeFrame: Baseline and 3 months
measure: Change in Conflict
timeFrame: Baseline and 3 months
measure: Parenting
timeFrame: Baseline
measure: Change in Parental Monitoring
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Bree M Holtz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.