Audio Health Engagement Analysis in Diabetes: The AHEAD Study

NCT01938807 | Completed

• 1 other identifier: UCSF 12-09213
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Keywords

type 1 diabetes; parents; mobile application; diabetes management

Outcome Measures

Primary Outcomes (1)

• Diabetes Management

  6 months post-baseline

Secondary Outcomes (1)

• Hemoglobin A1c

  6 months post-baseline

Other Outcomes (1)

• Satisfaction and usability of the mobile application

  6 months post-baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group receives the CareCoach mobile application

Behavioral: CareCoach mobile application to assist in diabetes management

Control

ACTIVE COMPARATOR

The control group receives standard care.

Behavioral: CareCoach mobile application to assist in diabetes management

Interventions

CareCoach mobile application to assist in diabetes management BEHAVIORAL

Control; Intervention

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Diana Naranjo, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: October 1, 2013
• Primary Completion: September 29, 2015
• Study Completion: September 29, 2015
• Last Updated: January 27, 2020

Record last verified: 2020-01