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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transition preparation intervention
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Transition, Young Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Richmond at Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transition preparation program

Arm Description

Transition preparation intervention for young adults with type 1 diabetes (T1D)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2019
Last Updated
November 5, 2020
Sponsor
Virginia Commonwealth University
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT03998475
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Transition, Young Adult

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transition preparation program
Arm Type
Experimental
Arm Description
Transition preparation intervention for young adults with type 1 diabetes (T1D)
Intervention Type
Behavioral
Intervention Name(s)
Transition preparation intervention
Intervention Description
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 Outcome Measure Information:
Title
Number of sessions attended
Description
Number of study visits (attendance)
Time Frame
6 months
Title
Number of session views
Description
Number of opened electronic materials (e.g., opened messages in the patient health portal))
Time Frame
6 months
Title
Program acceptability - young adult
Description
Young adult report on satisfaction with the program via an exit survey
Time Frame
9 months
Title
Program acceptability - parent
Description
Parent report on satisfaction with the program via an exit survey
Time Frame
9 months
Title
Program acceptability - provider
Description
Provider report on satisfaction with the program via an exit survey
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change in Glycemic control
Description
Measurement of hemoglobin A1c (A1c; reported as a percentage)
Time Frame
Baseline to 9 months
Title
Diabetes-related hospitalizations
Description
Participant report and medical record review of count of reported diabetes-related hospitalizations and complications
Time Frame
9 months
Title
Change in adherence to diabetes care regimen
Description
Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)
Time Frame
Baseline to 9 months
Title
Change in transition readiness
Description
Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)
Time Frame
Baseline to 9 months
Other Pre-specified Outcome Measures:
Title
Change in diabetes self-efficacy
Description
Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)
Time Frame
Baseline to 9 months
Title
Change in diabetes quality of life
Description
Participant (young adult) report on the Pediatric Quality of Life Diabetes Module
Time Frame
Baseline to 9 months
Title
Change in diabetes family responsibility
Description
Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)
Time Frame
Baseline to 9 months
Title
Change in diabetes family conflict
Description
Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)
Time Frame
Baseline to 9 months
Title
Change in depression
Description
Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)
Time Frame
Baseline to 9 months
Title
Change in young adult diabetes distress
Description
Participant (young adult) report on the Diabetes Distress Scale
Time Frame
Baseline to 9 months
Title
Change in parent diabetes distress
Description
Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D
Time Frame
Baseline to 9 months
Title
Change in autonomy support
Description
Participant (young adult) report on the autonomy support sub-scale of the Barriers to Diabetes Adherence Questionnaire
Time Frame
Baseline to 9 months
Title
Change in problem solving
Description
Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire
Time Frame
Baseline to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Caccavale, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melanie Melanie, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

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