Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-11-14
2027-11-30
Brief Summary
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Does the Discovery Program lead to better glycemic control as measured by HbA1c levels? How does participation in the Discovery Program affect diabetes distress and self-management skills? Researchers will compare participants in the Discovery Program to those receiving standard diabetes care to see if the program has a positive effect on diabetes management.
Participants will:
Engage in a 3-month intervention that includes personalized mobile health communications and clinician support.
Complete surveys and assessments at the beginning of the study, and again at 3 and 6 months.
Allow the study team to access their electronic health records for additional data on diabetes management.
Detailed Description
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Study Design: Participants will be randomly assigned to either the intervention group, which will receive the Discovery Program, or a control group receiving standard diabetes care. The Discovery Program includes personalized mobile health communications, clinician support, and structured problem-solving sessions aimed at addressing psychosocial barriers to effective diabetes management.
Objectives: The primary objective is to determine whether the Discovery Program leads to significant improvements in glycemic control, measured by changes in HbA1c levels over a 6-month period. Secondary objectives include assessing the impact on diabetes distress, self-management behaviors, and participants' problem-solving skills.
Data Collection: Data will be collected at baseline, 3 months, and 6 months, utilizing a variety of methods, including surveys and electronic health records (EHR). The study will ensure participant confidentiality through the use of unique study IDs and secure, HIPAA-compliant data storage systems, such as REDCap.
Eligibility Criteria: Eligible participants include those aged 13-21 with a diagnosis of type 1 diabetes, while individuals with type 2 diabetes or other conditions that may hinder participation will be excluded.
Retention and Use of Data: All collected data will be retained for at least six years post-study completion, in compliance with institutional and regulatory requirements. De-identified data may be used for research publications or presentations, ensuring participant privacy is maintained throughout the study.
This trial aims to provide valuable insights into improving diabetes management strategies for young individuals facing unique challenges in their care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group: Discovery Program
This arm will receive the Discovery Program intervention, which includes personalized mobile health communications and clinician support aimed at improving diabetes management.
Discovery Program
The Discovery Program is a novel, hybrid intervention specifically designed to address the psychosocial barriers faced by adolescents and young adults with T1D. This intervention integrates three key components:
1. Patient-Reported Measures
2. In-Clinic Collaborative Goal Setting
3. Personalized Mobile Health Communications
The Discovery Program will be delivered over a 3-month intervention period, followed by a 6-month follow-up to assess outcomes. This approach not only aims to improve glycemic control but also seeks to enhance diabetes self-management behaviors, reduce diabetes distress, and build problem-solving skills among participants. The integration of clinical informatics, personalized support, and mobile health technology distinguishes this intervention from traditional diabetes care practices, which often overlook psychosocial factors affecting health outcomes.
Control Group: Standard Diabetes Care
This arm will continue with standard diabetes care practices without the additional psychosocial intervention provided to the intervention group.
No interventions assigned to this group
Interventions
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Discovery Program
The Discovery Program is a novel, hybrid intervention specifically designed to address the psychosocial barriers faced by adolescents and young adults with T1D. This intervention integrates three key components:
1. Patient-Reported Measures
2. In-Clinic Collaborative Goal Setting
3. Personalized Mobile Health Communications
The Discovery Program will be delivered over a 3-month intervention period, followed by a 6-month follow-up to assess outcomes. This approach not only aims to improve glycemic control but also seeks to enhance diabetes self-management behaviors, reduce diabetes distress, and build problem-solving skills among participants. The integration of clinical informatics, personalized support, and mobile health technology distinguishes this intervention from traditional diabetes care practices, which often overlook psychosocial factors affecting health outcomes.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with T1D for at least one year,
* Access to a smartphone,
* A My Health at Vanderbilt (MHAV) patient portal account,
* Ability to read, speak, and understand English,
* An appointment with an NP in the VUMC Eskind Clinic within 7 months of initial contact
Exclusion Criteria
* Any physical, cognitive, sensory or emotional condition precluding participation in the intervention (seeing/using a phone, hearing digital stories, answering questions).
13 Years
21 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Shelagh Mulvaney
Principal Investigator
Principal Investigators
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Shelagh A Mulvaney, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt University
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Abigail Doyle, MSHI
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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250525
Identifier Type: -
Identifier Source: org_study_id