An interventional study of Transition preparation intervention in Type 1 Diabetes, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Both members of the youth/parent dyad must meet all eligibility criteria
Young adults
Parents
Medical providers
Exclusion Criteria:
Young adults
Parents
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.
Number of sessions attended
Number of study visits (attendance)
Time frame: 6 months
Number of session views
Number of opened electronic materials (e.g., opened messages in the patient health portal))
Time frame: 6 months
Program acceptability - young adult
Young adult report on satisfaction with the program via an exit survey
Time frame: 9 months
Program acceptability - parent
Parent report on satisfaction with the program via an exit survey
Time frame: 9 months
Program acceptability - provider
Provider report on satisfaction with the program via an exit survey
Time frame: 9 months
Change in Glycemic control
Measurement of hemoglobin A1c (A1c; reported as a percentage)
Time frame: Baseline to 9 months
Diabetes-related hospitalizations
Participant report and medical record review of count of reported diabetes-related hospitalizations and complications
Time frame: 9 months
Change in adherence to diabetes care regimen
Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)
Time frame: Baseline to 9 months
Change in transition readiness
Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: Baseline to 9 months
Change in diabetes self-efficacy
Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)
Time frame: Baseline to 9 months
Change in diabetes quality of life
Participant (young adult) report on the Pediatric Quality of Life Diabetes Module
Time frame: Baseline to 9 months
Change in diabetes family responsibility
Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)
Time frame: Baseline to 9 months
Change in diabetes family conflict
Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)
Time frame: Baseline to 9 months
Change in depression
Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)
Time frame: Baseline to 9 months
Change in young adult diabetes distress
Participant (young adult) report on the Diabetes Distress Scale
Time frame: Baseline to 9 months
Change in parent diabetes distress
Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D
Time frame: 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
Time frame: Baseline to 9 months
Change in problem solving
Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire
Time frame: Baseline to 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University