PETS-D (Parent Education Thru Simulation-Diabetes)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01517269|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : March 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: Parent education with human patient simulator Behavioral: Standard care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||PETS-D (Parent Education Thru Simulation-Diabetes)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Education with simulator
Parent randomized to this group will be taught diabetes management with vignette and simulator
Behavioral: Parent 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
Active Comparator: Control arm: standard diabetes education
Parents will receive standard diabetes education with a diabetes educator
Behavioral: Standard 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
- Change in baseline of Diabetes Knowledge [ Time Frame: 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.
- Change in Baseline of Problem solving [ Time Frame: 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 [ Time Frame: Baseline and 14 weeks ]Diabetes Management Outcomes is a 5 question likert scale based on ADA2 management recommendations.
- Change in Baseline of Diabetes self efficacy [ Time Frame: 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 Fear of hypoglycemia [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517269
|United States, Massachusetts|
|University of Massachusetts, Worcester|
|Worcester, Massachusetts, United States, 01655|