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Audio Health Engagement Analysis in Diabetes: The AHEAD Study

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ClinicalTrials.gov Identifier: NCT01938807
Recruitment Status : Unknown
Verified October 2014 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 audiorecord 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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: CareCoach mobile application to assist in diabetes management Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Audio Health Engagement Analysis in Diabetes: The AHEAD Study
Study Start Date : October 2013
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention
The intervention group receives the CareCoach mobile application
Behavioral: CareCoach mobile application to assist in diabetes management
Active Comparator: Control
The control group receives standard care.
Behavioral: CareCoach mobile application to assist in diabetes management



Primary Outcome Measures :
  1. Diabetes Management [ Time Frame: 6 months post-baseline ]

Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months post-baseline ]

Other Outcome Measures:
  1. Satisfaction and usability of the mobile application [ Time Frame: 6 months post-baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938807


Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Diana Naranjo, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01938807     History of Changes
Other Study ID Numbers: UCSF 12-09213
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Keywords provided by University of California, San Francisco:
type 1 diabetes
parents
mobile application
diabetes management

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases