Audio Health Engagement Analysis in Diabetes: The AHEAD Study

NCT ID: NCT01938807

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-09-29

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

The intervention group receives the CareCoach mobile application

Group Type: EXPERIMENTAL

CareCoach mobile application to assist in diabetes management

Intervention Type: BEHAVIORAL

Control

The control group receives standard care.

Group Type: ACTIVE_COMPARATOR

CareCoach mobile application to assist in diabetes management

Intervention Type: BEHAVIORAL

Interventions

CareCoach mobile application to assist in diabetes management

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Naranjo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

UCSF 12-09213

Identifier Type: -

Identifier Source: org_study_id