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Audio Health Engagement Analysis in Diabetes: The AHEAD Study

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CareCoach mobile application to assist in diabetes management
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, parents, mobile application, diabetes management

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • parent of a child with diagnosis of type 1 diabetes for at least one year
  • parent of a child with type 1 diabetes between the ages of 7-12
  • provide informed consent in English
  • have access to the internet from home

Exclusion Criteria:

  • no access to the internet
  • shorter duration of type 1 diabetes than one year

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    The intervention group receives the CareCoach mobile application

    The control group receives standard care.

    Outcomes

    Primary Outcome Measures

    Diabetes Management

    Secondary Outcome Measures

    Hemoglobin A1c

    Full Information

    First Posted
    September 5, 2013
    Last Updated
    January 22, 2020
    Sponsor
    University of California, San Francisco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01938807
    Brief Title
    Audio Health Engagement Analysis in Diabetes: The AHEAD Study
    Official Title
    Audio Health Engagement Analysis in Diabetes: The AHEAD Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    September 29, 2015 (Actual)
    Study Completion Date
    September 29, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Despite multidisciplinary care and advancements in therapeutics and technology, health outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to poor outcomes is suboptimal diabetes management in pediatric patients and their families. The premise of this research project is that patients and families do not have adequate resources to meet the level of diabetes management that translates to better outcomes. Therefore, we will give them a valuable tool to improve their overall management. The tool is CareCoach. Research shows that enhancing communication and partnership among patients, parents, and providers is especially critical for optimal outcomes in pediatric diabetes. Communication gaps and conflict can complicate the already complex provider-patient interactions and daily management. We have therefore designed, refined, and made available to consumers a new mobile-based intervention, CareCoach, to improve communication; build trust among providers, patients and parents; and increase overall satisfaction with the quality of diabetes care. This web/mobile application is designed to help patients unobtrusively audio record their clinical encounters, track their medical consults and treatment plans, review information from past visits, create visit discussion guides, and track adherence to medication and dosing schedules. In addition, because mobile-based applications are inexpensive to administer, portable, and available at all times of day, CareCoach holds great promise for communication coaching and contributing to improved diabetes management. We hypothesize that CareCoach will improve patient-parent-provider communications, build patient-parent-provider trust, and increase overall satisfaction with clinical interactions in a sample of children with type 1 diabetes and their parents. These improvements will lead to significant gains in diabetes management, setting the stage for optimal health outcomes. To test the effectiveness of CareCoach, we will conduct a randomized controlled trial comparing the CareCoach intervention to standard care in a sample of 60 children with type 1 diabetes and their parents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    type 1 diabetes, parents, mobile application, diabetes management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The intervention group receives the CareCoach mobile application
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The control group receives standard care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CareCoach mobile application to assist in diabetes management
    Primary Outcome Measure Information:
    Title
    Diabetes Management
    Time Frame
    6 months post-baseline
    Secondary Outcome Measure Information:
    Title
    Hemoglobin A1c
    Time Frame
    6 months post-baseline
    Other Pre-specified Outcome Measures:
    Title
    Satisfaction and usability of the mobile application
    Time Frame
    6 months post-baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: parent of a child with diagnosis of type 1 diabetes for at least one year parent of a child with type 1 diabetes between the ages of 7-12 provide informed consent in English have access to the internet from home Exclusion Criteria: no access to the internet shorter duration of type 1 diabetes than one year
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diana Naranjo, PhD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Audio Health Engagement Analysis in Diabetes: The AHEAD Study

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