Transition Preparation Intervention for Young Adults With Type 1 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Transition preparation intervention

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: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Children's Hospital of Richmond at Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sessions attended	Number of study visits (attendance)	6 months
Number of session views	Number of opened electronic materials (e.g., opened messages in the patient health portal))	6 months
Program acceptability - young adult	Young adult report on satisfaction with the program via an exit survey	9 months
Program acceptability - parent	Parent report on satisfaction with the program via an exit survey	9 months
Program acceptability - provider	Provider report on satisfaction with the program via an exit survey	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycemic control	Measurement of hemoglobin A1c (A1c; reported as a percentage)	Baseline to 9 months
Diabetes-related hospitalizations	Participant report and medical record review of count of reported diabetes-related hospitalizations and complications	9 months
Change in adherence to diabetes care regimen	Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)	Baseline to 9 months
Change in transition readiness	Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)	Baseline to 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diabetes self-efficacy	Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)	Baseline to 9 months
Change in diabetes quality of life	Participant (young adult) report on the Pediatric Quality of Life Diabetes Module	Baseline to 9 months
Change in diabetes family responsibility	Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)	Baseline to 9 months
Change in diabetes family conflict	Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)	Baseline to 9 months
Change in depression	Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)	Baseline to 9 months
Change in young adult diabetes distress	Participant (young adult) report on the Diabetes Distress Scale	Baseline to 9 months
Change in parent diabetes distress	Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D	Baseline to 9 months
Change in autonomy support	Participant (young adult) report on the autonomy support sub-scale of the Barriers to Diabetes Adherence Questionnaire	Baseline to 9 months
Change in problem solving	Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire	Baseline to 9 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Laura Caccavale, PhD, Virginia Commonwealth University; Principal Investigator: Melanie Melanie, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): September 16, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Transition; Young Adult
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HM20015399; 1-19-PDF-041-R (Other Grant/Funding Number: American Diabetes Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No