Transition Preparation Intervention for Young Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998475
• Other study ID #: HM20015399
• Secondary ID: 1-19-PDF-041-R
• Status: Completed
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: September 16, 2020

Study information

• Verified date: November 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in diabetes self-efficacy	Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)	Baseline to 9 months
Other	Change in diabetes quality of life	Participant (young adult) report on the Pediatric Quality of Life Diabetes Module	Baseline to 9 months
Other	Change in diabetes family responsibility	Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)	Baseline to 9 months
Other	Change in diabetes family conflict	Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)	Baseline to 9 months
Other	Change in depression	Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)	Baseline to 9 months
Other	Change in young adult diabetes distress	Participant (young adult) report on the Diabetes Distress Scale	Baseline to 9 months
Other	Change in parent diabetes distress	Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D	Baseline to 9 months
Other	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
Other	Change in problem solving	Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire	Baseline to 9 months
Primary	Number of sessions attended	Number of study visits (attendance)	6 months
Primary	Number of session views	Number of opened electronic materials (e.g., opened messages in the patient health portal))	6 months
Primary	Program acceptability - young adult	Young adult report on satisfaction with the program via an exit survey	9 months
Primary	Program acceptability - parent	Parent report on satisfaction with the program via an exit survey	9 months
Primary	Program acceptability - provider	Provider report on satisfaction with the program via an exit survey	9 months
Secondary	Change in Glycemic control	Measurement of hemoglobin A1c (A1c; reported as a percentage)	Baseline to 9 months
Secondary	Diabetes-related hospitalizations	Participant report and medical record review of count of reported diabetes-related hospitalizations and complications	9 months
Secondary	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
Secondary	Change in transition readiness	Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)	Baseline to 9 months