An interventional study of MyT1DHero and Other T1D Mobile App in Type1diabetes, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Michigan State University · Not applicable, Interventional, and Supportive care
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.
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The adolescents must:
The parent/guardian must:
Exclusion Criteria:
For the adolescents include:
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.
Participants in this group will receive use of the MyT1DHero app.
Device: MyT1DHero
Participants in this group will receive use of a different app with less capabilities.
Device: Other T1D Mobile App
MyT1DHero is an app with two separate interfaces, one for the parent and one for the child, that work together to help them communicate about diabetes management. The child receives system reminders to enter their blood glucose numbers, and parents receive a notification about each blood glucose test their child enters. Parents are also able to use the app to communicate with their child about their plan for care. The app has customizable blood glucose reminders and ranges, videos of support from other adolescents with T1D, snack lists, and other educational information on T1D.
A mobile app will be used in this control/comparison group that only has blood sugar testing reminders and logging capabilities. There will be no other components of the app.
Change from Baseline Diabetes Behavior Rating Scale at 12 months
A measure of diabetes adherence for both parent and child participants. Never (1) - Always(5) with a higher score indicating better adherence.
Time frame: Baseline and 12 months
Change from Baseline HbA1c at 6 months and 12 months
A laboratory test that measures how high blood glucose has been on average over the last 8-12 weeks - for child participants only (Lower number is best)
Time frame: Baseline, 6 months, and 12 months
Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months
A measure of social support for the parent participants. Never (1) - Always (5), with a higher score indicating better support.
Time frame: Baseline and 12 months
Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months
A measure of social support for the parent participants. Never (1) - Always (5), with a higher score indicating more support.
Time frame: Baseline and 12 months
Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months
A measure of social support for the child participants. Never (1) - Always (5), with a higher score indicating more support.
Time frame: Baseline and 12 months
Change from Baseline Diabetes Empowerment Scale Short Form at 12 months
A measure of diabetes-related self-efficacy for both parent and child participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more empowerment.
Time frame: Baseline and 12 months
Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months
A measure of self-efficacy for the parent participants. I am not at all confident (1) - I am very confident (5), with a higher score indicating higher self-efficacy.
Time frame: Baseline and 12 months
Change from Baseline NIH Toolbox Self-efficacy (ages 8-12) at 12 months
A measure of self-efficacy for the child participants. Never (1) - Very often (5), with a higher score indicating higher self-efficacy.
Time frame: Baseline and 12 months
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
A measure of diabetes-related self-efficacy for the child participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more confidence in self-care ability.
Time frame: Baseline and 12 months
Change from Baseline PROMIS® Item Bank v1.0 - General Life Satisfaction - Short Form 5a at 12 months
A measure of quality of life for the parent participants. Strongly disagree (1) - Strongly agree (7), with a higher score indicating more life satisfaction.
Time frame: Baseline and 12 months
Change from Baseline PedsQL (Measurement Model for the Pediatric Quality of Life Inventory) at 12 months
A measure of quality of life for the child participants. Never (0) - Almost Always (4), with a lower score indicating better quality of life.
Time frame: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Stigma - Short Form at 12 months
A measure of stigma for the child participants. Never (1) - Always (5), with a higher score indicating more feelings of stigma.
Time frame: Baseline and 12 months
Change from Baseline Diabetes Conflict Scale at 12 months
A measure of conflict for both the parent and child participants. Almost Always (1) - Never (3), with a higher score indicating less conflict.
Time frame: Baseline and 12 months
Change from Baseline PROMIS® Parent Proxy Item Bank v1.0 - Family Relationships - Short Form 8a at 12 months
A measure of family characteristics for both the parent and child participants. Never (1) - Always (4), with a higher score indicating better family relationships.
Time frame: Baseline and 12 months
Change from Baseline Diabetes Family Behavior Scale at 12 months
A measure of family characteristics for both the parent and child participants. All of the time (1) - Never (5), with a lower score indicating better family behavior.
Time frame: Baseline and 12 months
Change from Baseline Family Functioning Scale at 12 months
A measure of family characteristics for both the parent and child participants. Totally disagree (1) - Totally agree (6). Responses are summed. Subscales include intimacy (items 1, 4, 6, 10, 13, 15, 18, 20, 23, 26, 27, 29), conflict (items 3, 5, 8, 9, 12, 14, 17, 19, 22, 24), and parenting style (items 2, 7, 11, 16, 21, 25, 28, 30).
Time frame: Baseline and 12 months
Change from Baseline Impact on Family (Construct: Parental perceptions of the impact of a child's medical condition on the family) at 12 months
A measure of family characteristics for the parent participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more impact (burden).
Time frame: Baseline and 12 months
Change from Baseline Family Satisfaction (FSS) at 12 months
A measure of family characteristics for the parent participants. Very dissatisfied (1) - Extremely satisfied (5), with a higher score indicating more satisfaction.
Time frame: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Anxiety - Short Form at 12 months
A measure of anxiety for the parent participants. Never (1) - Always (5), with a higher score indicating more anxiety.
Time frame: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Anxiety - Short Form at 12 months
A measure of anxiety for the child participants. Never (1) - Almost always (5), with a higher score indicating more anxiety; Not at all (1) - Very much (5); with a higher score indicating more anxiety.
Time frame: Baseline and 12 months
Change from Baseline Short-Form Outcome Expectations at 12 months
A measure of diabetes outcome expectancy for both the parent and child participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more positive outcome expectations
Time frame: Baseline and 12 months
Usability and Satisfaction Questionnaire
A measure of technology usability and satisfaction for both the parent and child participants
Time frame: 12 months
Unified theory of acceptance and use of technology (UTAUT) Vantakesh, Morris, et al., 2003
A measure of technology usability and satisfaction for both the parent and child participants
Time frame: 12 months
Plan to share: Undecided
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