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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

Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE July 11, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Number of sessions attended [ Time Frame: 6 months ]
    Number of study visits (attendance)
  • Number of session views [ Time Frame: 6 months ]
    Number of opened electronic materials (e.g., opened messages in the patient health portal))
  • Program acceptability - young adult [ Time Frame: 9 months ]
    Young adult report on satisfaction with the program via an exit survey
  • Program acceptability - parent [ Time Frame: 9 months ]
    Parent report on satisfaction with the program via an exit survey
  • Program acceptability - provider [ Time Frame: 9 months ]
    Provider report on satisfaction with the program via an exit survey
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Program feasibility [ Time Frame: 6 months ]
    Combined sum of study visits (attendance) and opened electronic materials (engagement with technology components (e.g., opened messages in the patient health portal))
  • Program acceptability - young adult [ Time Frame: 9 months ]
    Young adult report on satisfaction with the program via an exit survey
  • Program acceptability - parent [ Time Frame: 9 months ]
    Parent report on satisfaction with the program via an exit survey
  • Program acceptability - provider [ Time Frame: 9 months ]
    Provider report on satisfaction with the program via an exit survey
Change History Complete list of historical versions of study NCT03998475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Change in Glycemic control [ Time Frame: Baseline to 9 months ]
    Measurement of hemoglobin A1c (A1c; reported as a percentage)
  • Diabetes-related hospitalizations [ Time Frame: 9 months ]
    Participant report and medical record review of count of reported diabetes-related hospitalizations and complications
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2019)
  • Change in diabetes self-efficacy [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)
  • Change in diabetes quality of life [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Pediatric Quality of Life Diabetes Module
  • 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)
  • 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)
  • Change in depression [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)
  • Change in young adult diabetes distress [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Diabetes Distress Scale
  • 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
  • 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
  • Change in problem solving [ Time Frame: Baseline to 9 months ]
    Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Transition Preparation Intervention for Young Adults With Type 1 Diabetes
Official Title  ICMJE Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Transition preparation program
Transition preparation intervention for young adults with type 1 diabetes (T1D)
Intervention: Behavioral: Transition preparation intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Caccavale, PhD 804-527-4782 Laura.Caccavale@vcuhealth.org
Contact: Sarah Farthing 804-527-4759 malonese@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998475
Other Study ID Numbers  ICMJE HM20015399
1-19-PDF-041-R ( Other Grant/Funding Number: American Diabetes Association )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Laura Caccavale, PhD Virginia Commonwealth University
Principal Investigator: Melanie Melanie, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP