Constructed Intervention by Home and School Diabetes Nurs... | NCT01382459

Studies
Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes

NCT01382459

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Jun 27, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

Not provided

Countries

Israel

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

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

Jun 24, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Name	Class
Clalit Health Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.

Detailed Description

The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:

A decrease in HbA1C levels.
A decrease in Hypoglycemia events.
A decrease in DKA events.
A decrease in patients' visits in ER and hospitalizations.
An improvement in the knowledge of the patients and their families about the disease.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
type 1 DM children- intervention group		will have home visits and trainings at school
type 1 DM children- control group		will receive the standard care at the clinic

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 DM diagnosis from at least 8 months/
HbA1C levels >8
Signed inform consent.

Exclusion Criteria:

- Children who are not in educational settings and are not hebrew or arabic speakers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eli Hershkovitz, PI	Contact	972- 522629025		elih@bgu.ac.il
Addi Maabari, S.C	Contact	972-547280902		adimaa@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka medical center		Beersheba	Israel		Israel

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