Study of A Cell-Phone System to Improve Health of Youth W... | NCT02280564

Studies
Study of A Cell-Phone System to Improve Health of Youth With Diabetes

NCT02280564

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Oct 31, 2014Estimated

Enrollment

74Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

health coaching with technology support

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

ID	Type	Description	Link
R21DK085483-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 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

Mar 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Oct 29, 2014

First Posted Date

Oct 31, 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

Oct 29, 2014

Last Update Posted Date

Oct 31, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Mayer-Davis, PhD, Professor, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

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

FL3X is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. Utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.

Detailed Description

FL3X utilizes diabetes care providers (diabetes educators) as health coaches to employ behavioral modification techniques including motivational interviewing and problem solving skills training. Coaches help adolescents and their families learn these techniques to improve diabetes self management behaviors and diabetes care.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Standard diabetes care
Health coaching with technology support	Experimental	Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support.	Behavioral: health coaching with technology support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
health coaching with technology support	Behavioral	Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in HbA1c at 4 months		4 months

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Quality of Life measures at 4 months	Quality of Life will be assessed via self report questionnaire data.	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 1 diabetes with duration at least 12 months
between ages 12-16 years at registration
poor glycemic control (A1c 8.0-13.0%)
parent/guardian willing to also participate
minority race/ethnicity
low income

Exclusion Criteria:

pregnant (if female)
diabetes type 2 or gestational
no health insurance
Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth Mayer-Davis, PhD	UNC-CH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Barbara Davis Center for Childhood Diabetes		Aurora	Colorado	80045	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