PETS-D (Parent Education Thru Simulation-Diabetes)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Susan Sullivan-Bolyai, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01517269
First received: January 13, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Behavioral: Parent education with human patient simulator
Behavioral: Standard care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: PETS-D (Parent Education Thru Simulation-Diabetes)

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Change in baseline of Diabetes Knowledge [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Baseline of Problem solving [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517269

Locations
United States, Massachusetts
University of Massachusetts, Worcester
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Susan Sullivan-Bolyai, Study Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01517269     History of Changes
Other Study ID Numbers: 13643
Study First Received: January 13, 2012
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Parent education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014