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Skype for Youth With Poorly Controlled Diabetes (SKYPE)

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ClinicalTrials.gov Identifier: NCT02274103
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Michael A. Harris, PhD, Oregon Health and Science University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: BFST Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes
Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael A. Harris, PhD, Professor, Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02274103    
Other Study ID Numbers: 6000
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases