Clinical trial NCT01938807: Audio Health Engagement Analysis in Diabetes: The AHEAD Study
Official title: Audio Health Engagement Analysis in Diabetes: The AHEAD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
parents
mobile application
diabetes management
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 43
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Diabetes Management
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months post-baseline
Other outcomes:
measure: Satisfaction and usability of the mobile application
timeFrame: 6 months post-baseline
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Diana Naranjo, PhD
role: PRINCIPAL_INVESTIGATOR
References: