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
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
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
NCT ID
NCT01938807
First Posted
September 5, 2013
Last Updated
January 22, 2020
Sponsor
University of California, San Francisco
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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