Type 1 Diabetes
Conditions
Brief summary
The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are: 1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention. 2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.
Interventions
OTHERpersonalized comprehensive diabetes support
personalized comprehensive diabetes support
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Families of children 16 years of age or younger with a new diagnosis * Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration.
Exclusion criteria
* Families of children older than 16 years * Children from non-English speaking families
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale | 24 months | The Distress Scale (DDS) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 72. A higher score indicates higher distress. |
| Problem Areas in Diabetes (PAID) | 24 months | The Problem Areas in Diabetes (PAID) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 100. A higher score indicates higher distress. |
Countries
United States
Outcome results
None listed