Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?

Diabetes Clinical Trial

Official title:

Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653013
• Other study ID #: 18-00649
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center

• English speaking families

Exclusion Criteria:

• not english speaking

• diagnosed with type 1 diabetes within the last 6 months

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Glycinemia

Intervention

Behavioral:
• Usual standard of care
Participants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study.
• Neuropsychological Consultation
Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)		0 Months
Primary	Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)		3 Months
Primary	Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)		6 Months
Primary	Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)		9 Months