DiaBetter Together for Young Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: DiaBetter Together
* Behavioral: Peer Mentor Delivery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DiaBetter Together Intervention<br>Young Adult participants with type 1 diabetes (ages 17-25) who are approaching transfer from pediatric to adult care will be randomized to either the DiaBetter Together Intervention group or the Usual Care group. After randomization to the intervention group, young adults will be assigned a Peer Mentor. Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult. In both conditions, participation in this study will not impact participants' ability to contact the pediatric TCH diabetes care team or any other medical services to receive medical care. | Behavioral: DiaBetter Together<br>* Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult, including (a) teaching and modeling strengths-based skills for goal-setting, problem-solving, and stress management; (b) guiding participants in obtaining support from their social support network (e.g., family, friends); (c) developing a plan for accountability around diabetes management and follow-up in adult care; (d) sharing his/her transition experiences and strategies for successfully navigating the adult healthcare system; (e) discussing how to prioritize diabetes self-care; and (f) assisting them in accessing diabetes-related resources (e.g., local diabetes groups, apps, social media). Contact will be in-person, by phone, email, text message, and/or video, approximately weekly for first 3 mos, approximately biweekly for next 3 mos, and approximately monthly for last 6 mos (while COVID-19 safety recommendations are in place, in-person meetings will not occur).<br>|
| Other: Peer Mentors<br>Peer Mentors will deliver the DiaBetter Together intervention and will also be enrolled as study participants to permit assessment of their own outcomes from delivering this peer support intervention to younger people with diabetes. Peer Mentors will be experienced young adults with T1D who have transferred to adult diabetes care. | Behavioral: Peer Mentor Delivery<br>* Peer Mentors deliver the intervention to multiple young adult participants, each for 12 months. Peer Mentors may take on one or more participants at a time, and Peer Mentors may stay in their role in the study (delivering the intervention) for 1-3 years.<br>|
| No Intervention: Usual Care<br>Participants randomized to the comparison condition will receive usual diabetes care only, without additional intervention through the study. They will participate in all study activities related to data collection, but will not receive the Peer Mentor intervention. In both conditions, participation in this study will not impact participants' ability to contact the pediatric TCH diabetes care team or any other medical services to receive medical care. | |
| No Intervention: Research Supplement<br>Following completion of 12-month data collection, a subset of participants from the Usual Care group will have the opportunity to complete an optional and additional week (7 days) of follow-up data collection to characterize general and diabetes-specific sleep patterns. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control (HbA1c) | HbA1c is the average blood glucose over 3-4 months. The American Diabetes Association recommends an HbA1c target of <7.0%. HbA1c is collected via fingerstick/blood assay at routine diabetes visits and will be extracted from the medical record at each clinic visit during the study period. At Baseline and 12 months, HbA1c will be collected using the following methods: Collection of most recent HbA1c from review of electronic medical chart (Texas Children's or Baylor College of Medicine) or medical records from outside provider (obtained with written permission from participant). A dried blood spot at-home Hemoglobin A1c kit (Whatman 903 card, BD Microtainer HI-Flow Contact-Activated Lancet) will be mailed to the participant to complete and return to the study team for analysis on the Vitros 4600 HbA1c assay (correlated with the DCA 2000). Collected for young adult participants in both arms, not Peer Mentors. | Baseline through 12-Month Post-Randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Adult Care Visit | Time will start on the date of the last pediatric care visit (may differ from date of enrollment in study). The event of interest is the date of the first adult care visit. Participants who do not follow-up with an adult care provider within 12 months of the last pediatric visit will be censored for the event at the 12-month time point. Collected for young adult participants in both arms, not Peer Mentors. | 12-Month Post-Randomization | 
| Diabetes Self-Management/Adherence (Self-Care Inventory-Revised, Short Form) | The Self-Care Inventory-Revised, Short Form (SCI-RSF) is a 9-item measure that asks respondents the frequency with which they completed diabetes self-management tasks in the past 1-2 months. Item responses range from (1) Never to (5) Always, higher scores = higher adherence. Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study). | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Health-Related Quality of Life (Type 1 Diabetes and Life) | The Type 1 Diabetes and Life (T1DAL) measure assesses diabetes-specific health-related quality of life. Participants will complete the T1DAL version for their age (Adolescent: 12-17, 23 items; Young Adult: 18-25, 27 items; Adult-1: 26-45, 27 items), which asks respondents to rate the degree to which each item is true about their everyday quality of life with diabetes. Items responses range from 1 (not at all true) to 5 (very true) and total and sub-scales scores are calculated from 1-100 (higher = better quality of life). Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre- and post-involvement in study). | Baseline and 12-Month Post-Randomization | 
| Diabetes Strengths (Diabetes Strengths and Resilience measure) | The Diabetes Strengths and Resilience (DSTAR) measure assesses participants' self-perceptions about what they do well with diabetes (known as diabetes strengths). Participants will complete the Young Adult version of the DSTAR, which asks respondents to rate how often the items represent their experiences/perspectives about their diabetes strengths. Items responses range from 0 (never) to 4 (almost always) and are calculated for total and subscale scores (higher = more strengths). Collected for young adult participants in both arms, not Peer Mentors. | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Social Support (Brief 2-Way Social Support Scale) | The Brief 2-Way Social Support Scale (Brief-2SSS) is a 12-item measure that assesses participants' experiences of giving and receiving social support. There are four scales: giving emotional support, giving instrumental support, receiving emotional support, and receiving instrumental support. Items responses range from 0 (not at all) to 5 (always) and are calculated for total and subscale scores (higher = more perceived support). Collected for young adult participants in both arms (baseline, 6, & 12 mos) and Peer Mentors (pre- and post-involvement in study). | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Diabetes Distress (Diabetes Distress Scale for Adults with T1D) | The Diabetes Distress Scale for Adults with T1D (DDS-T1D) is a 28-item self-report scale that measures participants' experiences with distress related to living with diabetes. It assesses seven dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friends/family distress. Items responses range from 1 (not a problem) to 6 (a very serious problem) and are calculated for total and subscale scores (higher = more distress). Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study). | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Depressive Symptoms (PROMIS Short Form Depression 4a) | The PROMIS Short Form Depression 4a consists of 4 items that are pulled from the PROMIS Depression Item Bank v1.0. These items assess how often the individual has been bothered by depression-related symptoms, including negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), and decreased positive affect and engagement (loss of interest, meaning, and purpose), over the last 7 days. Items responses range from 1 (never) to 6 (always) and are calculated into a total score (higher = more depressive symptoms). Collected for young adult participants in both arms, not Peer Mentors. | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Emotional Support (PROMIS Short Form Emotional Support 4a) | The PROMIS Short Form Emotional Support 4a assesses perceived feelings of being cared for and valued as a person and having supportive relationships. Participants respond to 4 items on a scale from 1(Never) to 5 (Always) and are calculated into a total score (higher = more perceived support). Collected for young adult participants in both arms, not Peer Mentors. | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Informational Support (PROMIS Short Form Informational Support 4a) | The PROMIS Short Form Informational Support 4a assesses perceptions about the information or resources others provide to them (adequacy, availability, helpfulness). Participants respond to 4 items on a scale from 1(Never) to 5 (Always) and are calculated into a total score (higher = more perceived support). Collected for young adult participants in both arms, not Peer Mentors. | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Social Isolation (PROMIS Short Form Social Isolation item) | The PROMIS Short Form Social Isolation item is a single-item measure from the PROMIS item bank that assesses participants' feelings of being isolated from other people. There is no time frame for responding to this measure. Participants respond to 1 item on a scale from 1 (Never) to 5 (Always), which is calculated into a total score (higher = more perceived isolation). Collected for young adult participants in both arms (baseline, 6, & 12 mos), not Peer Mentors. | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | The Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth (READDY) is a 46-item self-report scale that measures participants' preparation for the transition to adult diabetes care, including: knowledge of diabetes, navigation of diabetes care, management skills and behaviors, and insulin pump skills if applicable. Only 18 items from the 3 subscales [Knowledge (4 items - baseline and 12 mos only), Navigation (13 items, baseline, 6 and 12 mos), Health Behaviors (1 item, baseline and 12 mo only)] will be administered for this study. Items responses range from 0 (haven't thought about it) to 5 (yes, I can do this) and are calculated for a total score (higher = more ready). Collected for young adult participants in both arms (baseline, 6, & 12 mos), not Peer Mentors. | Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization | 
| General Quality of Life (Satisfaction with Life Scale) | The Satisfaction with Life Scale (SWLS) is a 5-item self-report scale that measures participants' perceptions about their life overall. Items responses range from 1 (strongly disagree) to 7 (strongly agree) and are calculated for a total score (higher = better quality of life). Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors. | Baseline and 12-Month Post-Randomization | 
| Subjective Sleep Experiences (Pittsburgh Sleep Quality Index - Revised) | The Pittsburgh Sleep Quality Index (PSQI) - Revised is a 9-item, self-report scale that measures several aspects of participants' sleep, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, and diabetes-related sleep disturbance (new items - not in original measure). This revised version excludes the following components from the original measure: daytime dysfunction and use of sleep-promoting medication. Participants complete 4 open-ended items on sleep latency, efficiency, and duration, 4 scaled-response items on sleep disturbance and diabetes-related sleep disturbance ranging from 0 (Not during past month) to 3 (Three or more times a week), and 1 scaled-response item on subjective sleep quality ranging from 0 (Very good) to 3 (Very bad). A global score is not calculated; subscales are calculated independently (higher = worse sleep quality). Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors. | Baseline and 12-Month Post-Randomization | 
| COVID-19 Protective Behaviors (Oelsner MESA COVID-19 - Revised) | The Oelsner MESA COVID-19 - Revised is a 10-item self-report scale that measures participants' social distancing and hygiene behaviors during the COVID-19 pandemic. Participants rate how often they engaged in specific precautionary behaviors at the peak of the pandemic (Spring/Summer 2020) and over the past month. Item responses range from 0 (Never) to 4 (Always) and are calculated for a total score (higher = engaged in precautionary behaviors more frequently). Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre-involvement in study). | Baseline and 12-Month Post-Randomization | 
| COVID-19 Experiences (COVID-19 Experiences Questionnaire for Young Adults with T1D) | The COVID-19 Experiences Questionnaire for Young Adults with T1D (CEQ-YAD) is a 37-item, self-report questionnaire assessing how the COVID-19 pandemic impacted young adults with type 1 diabetes, including items about: (1) overall impact of the COVID-19 pandemic, (2) changes in life circumstances due to the pandemic, (3) self and family exposure to COVID-19, (4) changes in diabetes management due to the pandemic, (5) changes in everyday activities and mood due to the pandemic, and (6) COVID-19 vaccine uptake (number, dates, and manufacturers of vaccines and boosters received; open-text about reasons for not being vaccinated). It uses mixed-methods, including scaled, Yes/No, and open-ended items asking about participants' experiences during the peak of the pandemic (Spring/Summer 2020) and over the past 12 months. A total score is calculated by summing response values from scaled and Yes/No items (higher = most negative/worst impact from COVID-19 pandemic). | Baseline and 12-Month Post-Randomization | 
| Stressful Events (Stressful Event Questionnaire) | The Stressful Event Questionnaire assess the number and types of stressful life events experienced during the past year. Participants are asked to select any stressful life events from a list (for example: financial stressors, legal troubles, change in employment, etc.) and to include any stressful events experienced that are not already listed. A total score is calculated by summing the number of events selected or included by the participant (higher = more stressful live events experienced). Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors. | Baseline and 12-Month Post-Randomization | 
| Social Vulnerability (CDC/ATSDR Social Vulnerability Index) | The CDC/ATSDR Social Vulnerability Index (SVI) uses 15 US census-tract level social variables grouped into four related themes, including (1) socioeconomic status (below poverty, unemployed, income, no high school diploma), (2) household composition & disability (aged 65 or older, aged 17 or younger, older than age 5 with a disability, single-parent households), and minority status & language (minority, speak English less than well), housing type & transportation (multi-unit structures, mobile homes, crowding, no vehicle, group quarters). Participants' address-level data collected at baseline are batch geocoded, transforming addresses into geographical coordinates using ArcGIS Pro Desktop software and the Street Map Premium package. Coordinates are intersected with census tract polygons, which can be linked to extant data tables, including variables in the SVI. A tract-level score for each of the four themes and an overall score measuring social vulnerability are obtained. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer Support, Adherence, Young Adult, Quality of Life, Transition, Resilience, Strengths-based, Sleep, COVID-19 Experiences