Clinical trial NCT04247620: DiaBetter Together for Young Adults with Type 1 Diabetes
Official title: DiaBetter Together: a Strengths-based, Peer Mentor Transition RCT for Young Adults with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Peer Support
Adherence
Young Adult
Quality of Life
Transition
Resilience
Strengths-based
Sleep
COVID-19 Experiences
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's National Research Institute
First posted: 2020-01-30
Enrollment: 144
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel two-group design will be used to evaluate the intervention among n=150 young adults randomly assigned to the peer support intervention or usual care (1:1). All young adults are randomized to either an intervention group, in which they all receive the same treatment in addition to usual diabetes care, or a control group, in which they receive usual diabetes care without the additional intervention. Young adult participants will be in the study for 12 months.

Peer Mentor participants (up to n=36) will deliver the intervention to young adults randomized to the intervention group, and their outcomes related to being a Peer Mentor will also be evaluated pre-post.
Primary purpose: SUPPORTIVE_CARE

Brief summary: DiaBetter Together is a strengths-based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The aims of this proposed randomized controlled trial are to evaluate the impact of the intervention on glycemic control (primary), time to first adult care visit, adherence, and psychosocial outcomes (secondary) in young adults with T1D after 12 months.

Detailed description: DiaBetter Together is a strengths based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The study aims to optimize transition in T1D by leveraging and building on young adults' diabetes strengths, self-management skills, and social supports. This intervention will maximize protective processes that can facilitate optimal transition by training Peer Mentors (experienced young adults with T1D who have successfully established care in an adult setting) to provide relevant information about successful transition, teach strengths-based skills for managing transition-related challenges, share personal transition-related experiences, encourage young adults to access their social support network, and serve as a positive role model. Delivery of these strengths-based intervention components through a Peer Mentor has potential to reduce isolation, increase access to relevant information, and facilitate engagement with self-management and T1D care. This intervention is a complement to existing systems of care for young adults with T1D for 12 months as they leave the pediatric setting.

Eligibility criteria: Young Adult Inclusion/Exclusion Criteria

Inclusion Criteria:

* has a diagnosis of type 1 diabetes of at least 1 year
* currently receiving care at a Texas Children's Hospital Diabetes Care Center location
* is between the ages of 17-25 years at enrollment
* exhibits fluency in reading/speaking English
* their endocrine provider confirmed plans to transfer to adult provider in the next 6 months

Exclusion Criteria:

* serious medical, cognitive, or mental health comorbidity that would preclude ability to provide informed consent or participate in data collection or intervention

Peer Mentor Inclusion/Exclusion Criteria

Inclusion Criteria:

* was diagnosed with type 1 diabetes before age 18
* has a diagnosis of type 1 diabetes of at least 1 years
* is between the ages of 20-35 at enrollment
* has been previously treated in pediatric care and is currently treated in adult care
* demonstrated interest and ability to effectively deliver the peer intervention \&
* exhibits fluency in reading/speaking English

Exclusion Criteria:

* serious medical, cognitive, or mental health comorbidity that would preclude ability to fulfill role or complete questionnaires.

Primary outcomes:
measure: Glycemic Control (HbA1c)
timeFrame: Baseline through 12-Month Post-Randomization
Secondary outcomes:
measure: Time to First Adult Care Visit
timeFrame: 12-Month Post-Randomization
measure: Diabetes Self-Management/Adherence (Self-Care Inventory-Revised, Short Form)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Health-Related Quality of Life (Type 1 Diabetes and Life)
timeFrame: Baseline and 12-Month Post-Randomization
measure: Diabetes Strengths (Diabetes Strengths and Resilience measure)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Social Support (Brief 2-Way Social Support Scale)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Diabetes Distress (Diabetes Distress Scale for Adults with T1D)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Depressive Symptoms (PROMIS Short Form Depression 4a)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Emotional Support (PROMIS Short Form Emotional Support 4a)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Informational Support (PROMIS Short Form Informational Support 4a)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Social Isolation (PROMIS Short Form Social Isolation item)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)
timeFrame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization
measure: General Quality of Life (Satisfaction with Life Scale)
timeFrame: Baseline and 12-Month Post-Randomization
measure: Subjective Sleep Experiences (Pittsburgh Sleep Quality Index - Revised)
timeFrame: Baseline and 12-Month Post-Randomization
measure: COVID-19 Protective Behaviors (Oelsner MESA COVID-19 - Revised)
timeFrame: Baseline and 12-Month Post-Randomization
measure: COVID-19 Experiences (COVID-19 Experiences Questionnaire for Young Adults with T1D)
timeFrame: Baseline and 12-Month Post-Randomization
measure: Stressful Events (Stressful Event Questionnaire)
timeFrame: Baseline and 12-Month Post-Randomization
measure: Social Vulnerability (CDC/ATSDR Social Vulnerability Index)
timeFrame: Baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Marisa E Hilliard, PhD
role: PRINCIPAL_INVESTIGATOR
References: