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Completed

NCT Number: NCT03998475

Transition Preparation Intervention for Young Adults With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Richmond at Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transition preparation intervention

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2019
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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