- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517269
PETS-D (Parent Education Thru Simulation-Diabetes)
March 6, 2015 updated by: Susan Sullivan-Bolyai, University of Massachusetts, Worcester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
191
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts, Worcester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education with simulator
Parent randomized to this group will be taught diabetes management with vignette and 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
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Active Comparator: Control arm: standard diabetes education
Parents will receive standard diabetes education with a diabetes educator
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 14 weeks
|
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.
|
Baseline and 14 weeks
|
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.
|
Baseline and 14 weeks
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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
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Baseline and 14 weeks
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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
|
Baseline and 14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
January 13, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Estimate)
March 9, 2015
Last Update Submitted That Met QC Criteria
March 6, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13643
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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