Home and School Visits Intervention for Children With DM... | NCT02137174

Studies
Home and School Visits Intervention for Children With DM TYPE 1

NCT02137174

Sponsor

Ben-Gurion University of the Negev

Status

Completed

Last Update Posted

May 13, 2014Estimated

Enrollment

92Actual

Phase

Phase 2Phase 3

Conditions

Diabetes Type 1

Interventions

Home and school visits

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

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

May 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

May 10, 2014

First Submission Date that Met QC Criteria

May 12, 2014

First Posted Date

May 13, 2014Estimated

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

May 12, 2014

Last Update Posted Date

May 13, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eli Hershkovitz, Head of Pediatric Endocrinology Unit, Ben-Gurion University of the NegevPrincipal Investigator

Lead Sponsor

Ben-Gurion University of the NegevOTHER

Collaborators

Not provided

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

Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home and school visits	Active Comparator		Other: Home and school visits
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home and school visits	Other	Each child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HBA1C		2 YEARS

Secondary Outcomes

Measure	Description	Time Frame
Number of DKA episodes		2 YEARS
Number of Hospitalizations		2 years
Hypoglycemia rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HbA1c ≥ 8% at baseline, and diabetes duration of at least 7 months.

Exclusion Criteria:

Patients during honeymoon period
Patients and their parents who do not speak Hebrew or Arabic
Patients who were not under any educational system
Patients who had other severe chronic disorders

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Endocrinology Unit, Soroka Medical Center		Beersheba		84101	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

Intervention Browse Module

MeSH Terms

ID	Term
D006699	Home Care Services

Ancestor Terms

ID	Term
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D009739	Nursing Services

Browse Leaves

Not provided

Browse Branches

Not provided