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Completed

NCT Number: NCT01517269

PETS-D (Parent Education Thru Simulation-Diabetes)

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent education with human patient simulator

Behavioral

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

Standard Care

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 25, 2012
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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