Type 1 Diabetes
Conditions
Keywords
Parent education
Brief summary
Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.
Interventions
BEHAVIORALParent education with human patient simulator
After child is newly diagnosed with Type 1 diabetes, parents will receive 3 teaching sessions over 12 weeks, after baseline data collected, at 1 month, and at 3 months, covering hypoglycemia, hyperglycemia and pattern management using teaching vignettes and practice with human patient simulator
BEHAVIORALStandard care
After child is newly diagnosed with Type 1 diabetes, parents will receive 3 teaching sessions over 12 weeks, after baseline data collected, at 1 month, and at 3 months, covering hypoglycemia, hyperglycemia and pattern management without the use of a simulator
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* parents 18 years and older who have a child newly diagnosed with type 1 diabetes mellitus (T1DM) from 5 years old to under 13 years of age
Exclusion criteria
* exclude children with developmental delays (such as Down Syndrome, Autism) or steroid induced diabetes (cancer treatment related or cystic fibrosis) * exclude parents who require insulin treatment -or- those that have another child with TIDM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline of Diabetes Knowledge | Baseline and 14 weeks | Diabetes Awareness and Reasoning Test-Parents (DART-P)is a 47-item multiple-choice questionnaire. The subscales include general, insulin, hyper-hypglycemia, and problem-solving. Parent education was a significant predictor of total scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline of Diabetes self efficacy | Baseline and 14 weeks | The Self-Efficacy Diabetes-Pediatrics (SED-P) will be used to measure parent confidence in specific task and skill associated diabetes care, i.e. how confident they feel to perform day-to-day diabetes management. |
| Change in Baseline of Problem solving | Baseline and 14 weeks | Wysocki's Modified Problem-solving measure18 (PSM) is a 5 item questionnaire that focuses on how to proactively prevent and treat hypoglycemia. Dr. Wysocki sent us one of his vignettes developed from the structured interview measure. Based on the examples of probes that are part of the interview, we constructed a 5-question multiple choice instrument to measure parental problem-solving abilities and knowledge synthesis. We will report the reliability and validity of this measure with data from the proposed study. |
| Change in Baseline of Diabetes management | Baseline and 14 weeks | Diabetes Management Outcomes is a 5 question likert scale based on ADA2 management recommendations. |
| Change in Baseline of Fear of hypoglycemia | Baseline and 14 weeks | The Hypoglycemia Fear Survey-Parents (HFS-P) total score will be used to measure parental fears and avoidance behaviors associated with hypoglycemia in their children.There are 2 subscales that measure parental concerns of their child experiencing an episode of hypoglycemia and behaviors they use to prevent these episodes from occurring |
| Change in Baseline of Parent anxiety | Baseline and 14 weeks | State-Trait Anxiety (STAI) is a well established 40-item instrument (Likert scale, with 1 being not at all, to 4 being almost always) used to measure situational (state, how one feels at this moment) and stable (trait, how one feels in general) tendencies toward anxiety. Higher scores signify more anxiety |
Countries
United States
Outcome results
None listed