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Trial record 19 of 87 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes (CHICAT1)

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ClinicalTrials.gov Identifier: NCT03084900
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tamara S. Hannon, Indiana University

Brief Summary:
Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Arm 1 Not Applicable

Detailed Description:
Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes. Computer decision support systems (CDSS) have scientifically demonstrated advantages for improving care, and the potential to revolutionize diabetes care because they allow for increased reactive and proactive contact with the health care team, real-time adherence support, and intensification of treatment. In this study,investigators will implement the ADA recommended standards of care using a CDSS developed by the research group - the Child Health Improvement through Computer Automation (CHICA) system.9 One of the greatest strengths of the CHICA system is its ability to implement evidence-based recommendations from authoritative sources, in this case the ADA, in a format that integrates easily into routine care. A second strength of the CHICA system is its ability to screen for patient-centered concerns, including barriers to optimal care such as literacy, socioeconomic issues (i.e., food insecurity, housing insecurity, etc.), and mental health issues (i.e., depression). The provider is alerted, and safety mechanisms are set in motion (i.e., referral to mental health provider, etc.) to address identified issues. In order to ensure that we design the most effective CDSS intervention possible, the study team, in collaboration with the Patient Engagement Core (PEC) of the Indiana Clinical and Translational Science Institute, will partner with adolescents, parents, and other stakeholders in a way that exceeds standard expectations for the engagement of these parties in research. Investigators have experience working directly with patients to elucidate patient-centered outcomes, identify determinants of adherence, and to co-design interventions that are inherently more patient-centered.10-14 By combining a patient-centered design approach along with CDSS investigators will be able to individually tailor recommendations to meet the real needs of patients, taking into account the adolescent patient's perspective and input. This truly innovative approach will offer improved technology-based support systems for diabetes management along with attention to patient-centered goals using co-designed interventions for diabetes self-management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention Arm 1 versus standard care.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient-Centered Decision Support
Intervention - computer decision support in diabetes clinic. Investigators will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures. The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.
Other: Arm 1
Patient-Centered Decision Support to Improve Diabetes Mgmt. We will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures.The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.

No Intervention: Standard Care
Standard pediatric diabetes care will be compared to the computerized decision support system.



Primary Outcome Measures :
  1. HbA1c value [ Time Frame: 4 years ]
    Measure of HbA1c value for youth subjects


Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 4 years ]
    Number of episodes of hypoglycemia during study

  2. DKA [ Time Frame: 4 years ]
    Number of episodes of DKA during study



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adolescents with type 1 diabetes
  2. Parents of adolescents with type 1 diabetes
  3. Friends/siblings of adolescents with type 1 diabetes
  4. Community partners who work with adolescents with type 1 diabetes
  5. Diabetes care providers

    -

    Exclusion Criteria:

    -


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): NCT03084900


Contacts
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Contact: Lisa Smith 3172789615 smithlg@iupui.edu

Locations
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United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lisa Smith    317-278-9615      
Sponsors and Collaborators
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Tamara Hannon, MD Indiana University

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Responsible Party: Tamara S. Hannon, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03084900     History of Changes
Other Study ID Numbers: 1612394802
1DP3DK113183-01 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases