Clinical trial NCT03521362: MyT1DHero: an mHealth Intervention for Type 1 Diabetes
Official title: MyT1DHero: A Randomized Controlled Trial of an mHealth Intervention to Improve Parent-child Communication and Adolescent Self-management of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Keywords: mHealth
Adolescent
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
name: American Diabetes Association
First posted: 2018-05-11
Enrollment: 33
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall objective of the proposed research is to improve HbA1c, adherence to treatment plans, and family communication surrounding adolescents' self-management of T1D. The investigators will test the efficacy of the MyT1DHero app against an attention control group. This will allow investigators to better understand the health and psychosocial improvements being made through the app.

Detailed description: This research seeks to realize the potential and test the efficacy of MyT1DHero to improve adolescent users' glycemic control and adherence to blood glucose monitoring. The investigators' goal is to help families receive more social support, and to improve diabetes knowledge, self-efficacy, family communication, and quality of life. The investigators further seek to decrease family conflict among children with T1D and their parents. In a 12-month RCT, investigators will randomize 166 adolescents and their parents to one of two groups: (1) attention control, or (2) the MyT1DHero app. Adolescents enrolled in the study will be 10-15 years old, and will have been living with T1D for \<1 year or \>5 years at the start of the study. The primary outcome will be a change in the participants' HbA1C from baseline levels at the start of the study, to levels measured after 12 months.

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 HbA1c \> 7,
  5. have had at least two outpatient visits in the past two years,
  6. be treated at Spectrum for diabetes,
  7. be fluent in English,
  8. have a parent/guardian willing to participate,
  9. have and be allowed to use a mobile phone for the study, and
  10. have permission from their care team to participate.

The parent/guardian must:

1. have an adolescent with T1D who is 10 to 15 years old,
2. be fluent in English, and
3. have daily access to email and the Internet (for appointment reminders and technical support).

Exclusion Criteria:

* For the adolescents include:

  1. significant medical conditions other than T1D,
  2. being treated for thyroid disorders, celiac disease, or eating disorders, and
  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 intellectual and developmental disabilities.

Primary outcomes:
measure: Change from Baseline Diabetes Behavior Rating Scale at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline HbA1c at 6 months and 12 months
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Diabetes Empowerment Scale Short Form at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline NIH Toolbox Self-efficacy (ages 8-12) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Confidence in Diabetes Self-Care (Psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and U.S. patients with type 1 diabetes) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline PROMIS® Item Bank v1.0 - General Life Satisfaction - Short Form 5a at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline PedsQL (Measurement Model for the Pediatric Quality of Life Inventory) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Stigma - Short Form at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Diabetes Conflict Scale at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline PROMIS® Parent Proxy Item Bank v1.0 - Family Relationships - Short Form 8a at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Diabetes Family Behavior Scale at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Family Functioning Scale at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Impact on Family (Construct: Parental perceptions of the impact of a child's medical condition on the family) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Family Satisfaction (FSS) at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Neuro-QOL Item Bank v1.0 -Anxiety - Short Form at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Anxiety - Short Form at 12 months
timeFrame: Baseline and 12 months
measure: Change from Baseline Short-Form Outcome Expectations at 12 months
timeFrame: Baseline and 12 months
measure: Usability and Satisfaction Questionnaire
timeFrame: 12 months
measure: Unified theory of acceptance and use of technology (UTAUT) Vantakesh, Morris, et al., 2003
timeFrame: 12 months
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References: