Assessment of Quality of Life and Satisfaction With Medic... | NCT00450489

Studies
Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients

NCT00450489

Sponsor

Children's Mercy Hospital Kansas City

Status

Withdrawn

Last Update Posted

Dec 16, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Mar 20, 2007

First Submission Date that Met QC Criteria

Mar 20, 2007

First Posted Date

Mar 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2020

Last Update Posted Date

Dec 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.

Detailed Description

Pediatric Type 1 Diabetes Mellitus patients and their parents will complete the forms before and 12 months after the diabetes clinic at Children's Mercy Hospital in Kansas City, MO transitions to a team model of care delivery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 Diabetes Mellitus six years of age and older who are receiving care in the diabetic clinic at Children's Mercy Hospital

Exclusion Criteria:

T1 Diabetes Mellitus patients not receiving care in the diabetes clinic at Children's Mercy Hospital or not meeting the age requirements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children cared for Type 1 Diabetes Mellitus, in Children's Mercy Hospital and Clinics, Endocrine Clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt Midyett, MD	Children's Mercy Hospital Kansas City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided