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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03998475
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Transition preparation intervention Not Applicable

Detailed Description:
The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Transition preparation program
Transition preparation intervention for young adults with type 1 diabetes (T1D)
Behavioral: Transition preparation intervention
Young adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits.




Primary Outcome Measures :
  1. Number of sessions attended [ Time Frame: 6 months ]
    Number of study visits (attendance)

  2. Number of session views [ Time Frame: 6 months ]
    Number of opened electronic materials (e.g., opened messages in the patient health portal))

  3. Program acceptability - young adult [ Time Frame: 9 months ]
    Young adult report on satisfaction with the program via an exit survey

  4. Program acceptability - parent [ Time Frame: 9 months ]
    Parent report on satisfaction with the program via an exit survey

  5. Program acceptability - provider [ Time Frame: 9 months ]
    Provider report on satisfaction with the program via an exit survey


Secondary Outcome Measures :
  1. Change in Glycemic control [ Time Frame: Baseline to 9 months ]
    Measurement of hemoglobin A1c (A1c; reported as a percentage)

  2. Diabetes-related hospitalizations [ Time Frame: 9 months ]
    Participant report and medical record review of count of reported diabetes-related hospitalizations and complications

  3. Change in adherence to diabetes care regimen [ Time Frame: Baseline to 9 months ]
    Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)

  4. Change in transition readiness [ Time Frame: Baseline to 9 months ]
    Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)


Other Outcome Measures:
  1. Change in diabetes self-efficacy [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)

  2. Change in diabetes quality of life [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Pediatric Quality of Life Diabetes Module

  3. Change in diabetes family responsibility [ Time Frame: Baseline to 9 months ]
    Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)

  4. Change in diabetes family conflict [ Time Frame: Baseline to 9 months ]
    Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)

  5. Change in depression [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)

  6. Change in young adult diabetes distress [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Diabetes Distress Scale

  7. Change in parent diabetes distress [ Time Frame: Baseline to 9 months ]
    Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D

  8. Change in autonomy support [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the autonomy support sub-scale of the Barriers to Diabetes Adherence Questionnaire

  9. Change in problem solving [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Both members of the youth/parent dyad must meet all eligibility criteria

Young adults

  • English-speaking
  • patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU)
  • between ages 18-22 yrs with a
  • diagnosis of T1D for >1 year

Parents

  • greater than 18 years of age
  • provide care to the young adult with T1D
  • are willing to participate in the intervention

Medical providers

• provide care to patients with T1D ages 18-22 yrs in Pediatric Endocrinology at CHoR

Exclusion Criteria:

Young adults

  • significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or
  • medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes

Parents

  • non-English speaking
  • psychiatric, cognitive, or developmental conditions that would impair their ability to complete assessments and/or engage in the intervention as determined at study screening

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): NCT03998475


Contacts
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Contact: Laura Caccavale, PhD 804-527-4782 Laura.Caccavale@vcuhealth.org
Contact: Sarah Farthing 804-527-4759 malonese@vcu.edu

Locations
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United States, Virginia
Children's Hospital of Richmond at Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
American Diabetes Association
Investigators
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Principal Investigator: Laura Caccavale, PhD Virginia Commonwealth University
Principal Investigator: Melanie Melanie, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03998475     History of Changes
Other Study ID Numbers: HM20015399
1-19-PDF-041-R ( Other Grant/Funding Number: American Diabetes Association )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 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
Keywords provided by Virginia Commonwealth University:
Transition
Young Adult
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