NCT01517269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

4.9 years

First QC Date

January 13, 2012

Last Update Submit

March 6, 2015

Conditions

Type 1 Diabetes

Keywords

Parent education

Outcome Measures

Primary Outcomes (1)

  • Change in baseline of Diabetes Knowledge

    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 Outcomes (5)

  • Change in Baseline of Problem solving

    Baseline and 14 weeks

  • Change in Baseline of Diabetes management

    Baseline and 14 weeks

  • Change in Baseline of Diabetes self efficacy

    Baseline and 14 weeks

  • Change in Baseline of Fear of hypoglycemia

    Baseline and 14 weeks

  • Change in Baseline of Parent anxiety

    Baseline and 14 weeks

Study Arms (2)

Education with simulator

EXPERIMENTAL

Parent randomized to this group will be taught diabetes management with vignette and simulator

Behavioral: Parent education with human patient simulator

Control arm: standard diabetes education

ACTIVE COMPARATOR

Parents will receive standard diabetes education with a diabetes educator

Behavioral: Standard care

Interventions

Parent education with human patient simulatorBEHAVIORAL

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

Education with simulator
Standard careBEHAVIORAL

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

Control arm: standard diabetes education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • Sullivan-Bolyai S, Crawford S, Bova C, Lee M, Quintos JB, Johnson K, Cullen K, Hamm T, Bisordi J, Ramchandani N, Fletcher J, Quinn D, Jaffarian C, Lipman T, Melkus G. PETS-D: Impact on Diabetes Management Outcomes. Diabetes Educ. 2015 Oct;41(5):537-49. doi: 10.1177/0145721715598383. Epub 2015 Aug 5.

    PMID: 26246593DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 25, 2012

Study Start

April 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

US(1)