Clinical trial NCT03998475: Transition Preparation Intervention for Young Adults With Type 1 Diabetes
Official title: Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Transition
Young Adult
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2019-06-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of sessions attended
timeFrame: 6 months
measure: Number of session views
timeFrame: 6 months
measure: Program acceptability - young adult
timeFrame: 9 months
measure: Program acceptability - parent
timeFrame: 9 months
measure: Program acceptability - provider
timeFrame: 9 months
Secondary outcomes:
measure: Change in Glycemic control
timeFrame: Baseline to 9 months
measure: Diabetes-related hospitalizations
timeFrame: 9 months
measure: Change in adherence to diabetes care regimen
timeFrame: Baseline to 9 months
measure: Change in transition readiness
timeFrame: Baseline to 9 months
Other outcomes:
measure: Change in diabetes self-efficacy
timeFrame: Baseline to 9 months
measure: Change in diabetes quality of life
timeFrame: Baseline to 9 months
measure: Change in diabetes family responsibility
timeFrame: Baseline to 9 months
measure: Change in diabetes family conflict
timeFrame: Baseline to 9 months
measure: Change in depression
timeFrame: Baseline to 9 months
measure: Change in young adult diabetes distress
timeFrame: Baseline to 9 months
measure: Change in parent diabetes distress
timeFrame: Baseline to 9 months
measure: Change in autonomy support
timeFrame: Baseline to 9 months
measure: Change in problem solving
timeFrame: Baseline to 9 months
Locations:
city: Richmond
country: United States
facility: Children's Hospital of Richmond at Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Laura Caccavale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Melanie Melanie, PhD
role: PRINCIPAL_INVESTIGATOR
References: