PETS-D (Parent Education Thru Simulation-Diabetes)

University of Massachusetts, Worcester

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Behavioral: Standard care; Behavioral: Parent education with human patient simulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01517269

13643

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191 participants in 2 patient groups

Education with simulator

Experimental group

Description:

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

Treatment:

Behavioral: Parent education with human patient simulator

Control arm: standard diabetes education

Active Comparator group

Description:

Parents will receive standard diabetes education with a diabetes educator

Treatment:

Behavioral: Standard care