Skype for Youth With Poorly Controlled Diabetes (SKYPE)

October 23, 2014 updated by: Michael A. Harris, PhD, Oregon Health and Science University

Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes

Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%
  • Caregivers willing to participate
  • Family members reading English at 5th grade level
  • Willing to be randomized.

Exclusion Criteria:

  • Youth with intellectual disability
  • Parent or youth who doesn't speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinic
BFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face.
Behavioral: BFST
Family-based skills training.
Active Comparator: Skype
BFST delivered to youth with poorly controlled diabetes and their families using Skype.
Behavioral: BFST
Family-based skills training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Change from Baseline to 3 months and from 3 months to 6 months
HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.
Change from Baseline to 3 months and from 3 months to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001).
Time Frame: Change from Baseline to 3 months and from 3 months to 6 months
DSMP scores for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.
Change from Baseline to 3 months and from 3 months to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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