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Audio Health Engagement Analysis in Diabetes: The AHEAD Study

Audio Health Engagement Analysis in Diabetes: The AHEAD Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01938807
Enrollment
43
Registered
2013-09-10
Start date
2013-10-31
Completion date
2015-09-29
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes, parents, mobile application, diabetes management

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.

Interventions

BEHAVIORALCareCoach mobile application to assist in diabetes management

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Diabetes Management6 months post-baseline

Secondary

MeasureTime frame
Hemoglobin A1c6 months post-baseline

Other

MeasureTime frame
Satisfaction and usability of the mobile application6 months post-baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026