Back to resultsMyT1DHero: an mHealth Intervention for Type 1 Diabetes
Primary Purpose
Type1diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyT1DHero
Other T1D Mobile App
Sponsored by
About this trial
This is an interventional supportive care trial for Type1diabetes focused on measuring mHealth, Adolescent
Eligibility Criteria
Inclusion Criteria:
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 HbA1c > 7,
- have had at least two outpatient visits in the past two years,
- be treated at Spectrum for diabetes,
- be fluent in English,
- have a parent/guardian willing to participate,
- have and be allowed to use a mobile phone for the study, and
- have permission from their care team to participate.
The parent/guardian must:
- have an adolescent with T1D who is 10 to 15 years old,
- be fluent in English, and
- have daily access to email and the Internet (for appointment reminders and technical support).
Exclusion Criteria:
For the adolescents include:
- significant medical conditions other than T1D,
- being treated for thyroid disorders, celiac disease, or eating disorders, and
- 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.
Sites / Locations
- Michigan State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MyT1DHero App
"Other" T1D App
Arm Description
Participants in this group will receive use of the MyT1DHero app.
Participants in this group will receive use of a different app with less capabilities.
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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
Usability and Satisfaction Questionnaire
A measure of technology usability and satisfaction for both the parent and child participants
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
Full Information
NCT ID
NCT03521362
First Posted
April 18, 2018
Last Updated
April 18, 2022
Sponsor
Michigan State University
Collaborators
Spectrum Health Hospitals, American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT03521362
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Spectrum Health Hospitals, American Diabetes Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
mHealth, Adolescent
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MyT1DHero App
Arm Type
Experimental
Arm Description
Participants in this group will receive use of the MyT1DHero app.
Arm Title
"Other" T1D App
Arm Type
Active Comparator
Arm Description
Participants in this group will receive use of a different app with less capabilities.
Intervention Type
Device
Intervention Name(s)
MyT1DHero
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Other T1D Mobile App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Diabetes Behavior Rating Scale at 12 months
Description
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
Title
Change from Baseline HbA1c at 6 months and 12 months
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months
Description
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
Title
Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months
Description
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
Title
Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months
Description
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
Title
Change from Baseline Diabetes Empowerment Scale Short Form at 12 months
Description
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
Title
Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months
Description
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
Title
Change from Baseline NIH Toolbox Self-efficacy (ages 8-12) at 12 months
Description
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
Title
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
Description
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
Title
Change from Baseline PROMIS® Item Bank v1.0 - General Life Satisfaction - Short Form 5a at 12 months
Description
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
Title
Change from Baseline PedsQL (Measurement Model for the Pediatric Quality of Life Inventory) at 12 months
Description
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
Title
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Stigma - Short Form at 12 months
Description
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
Title
Change from Baseline Diabetes Conflict Scale at 12 months
Description
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
Title
Change from Baseline PROMIS® Parent Proxy Item Bank v1.0 - Family Relationships - Short Form 8a at 12 months
Description
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
Title
Change from Baseline Diabetes Family Behavior Scale at 12 months
Description
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
Title
Change from Baseline Family Functioning Scale at 12 months
Description
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
Title
Change from Baseline Impact on Family (Construct: Parental perceptions of the impact of a child's medical condition on the family) at 12 months
Description
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
Title
Change from Baseline Family Satisfaction (FSS) at 12 months
Description
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
Title
Change from Baseline Neuro-QOL Item Bank v1.0 -Anxiety - Short Form at 12 months
Description
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
Title
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Anxiety - Short Form at 12 months
Description
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
Title
Change from Baseline Short-Form Outcome Expectations at 12 months
Description
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
Title
Usability and Satisfaction Questionnaire
Description
A measure of technology usability and satisfaction for both the parent and child participants
Time Frame
12 months
Title
Unified theory of acceptance and use of technology (UTAUT) Vantakesh, Morris, et al., 2003
Description
A measure of technology usability and satisfaction for both the parent and child participants
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 HbA1c > 7,
have had at least two outpatient visits in the past two years,
be treated at Spectrum for diabetes,
be fluent in English,
have a parent/guardian willing to participate,
have and be allowed to use a mobile phone for the study, and
have permission from their care team to participate.
The parent/guardian must:
have an adolescent with T1D who is 10 to 15 years old,
be fluent in English, and
have daily access to email and the Internet (for appointment reminders and technical support).
Exclusion Criteria:
For the adolescents include:
significant medical conditions other than T1D,
being treated for thyroid disorders, celiac disease, or eating disorders, and
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.
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://myt1dhope.msu.edu/
Description
T1D Parent Website
URL
http://myt1d.org/wordpress/
Description
Study Website
Learn more about this trial
MyT1DHero: an mHealth Intervention for Type 1 Diabetes
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