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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
144
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).
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.
Baylor College of Medicine
Houston, Texas, United States
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: 1. 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). 2. 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. Peer mentors self-reported HbA1c at baseline only.
Time frame: Baseline through 12-Month Post-Randomization
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.
Time frame: End of Study at 12 Months Post-Randomization
Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)
The Self-Care Inventory-Updated (SCI-U) is a 8-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. A total score is calculated by summing and averaging all items, with no subscales. The minimum possible score is 8 and the maximum possible score is 40. Higher scores indicate higher engagement in diabetes self-management behaviors. Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).
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Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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). Total scores are calculated by reverse-scoring items as indicated in the measure development paper instructions, then calculating a mean score and multiplying by 25 to convert the scores to a 100 point scale. The lowest possible total score is 0 and the highest possible total score is 100. Higher total scores = better T1D-specific health-related quality of life overall. Collected for young adult participants in both arms (baseline and 12 mo) and Peer Mentors (pre- and post-involvement in study).
Time frame: Baseline and End of Study at 12 Months 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). A total score is calculated by summing the 16 item responses. Lowest possible total score = 0, highest possible total score = 64. Higher total scores = more diabetes strengths. Collected for young adult participants in both arms, not Peer Mentors.
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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 experiences of giving and receiving social support. There are 4 scales: giving emotional support, giving instrumental support, receiving emotional support, receiving instrumental support. Items responses range 0 (not at all) to 5 (always). Higher scores = higher perceived support. Young adults complete all subscales at baseline and 12 months, and only the 2 "Receiving" subscales at 6 months. Peer Mentors completed all 4 subscales. A Total score (combined) is calculated by summing all items, Range 0-60. Collected for young adult participants in both arms (baseline \& 12 mos) and Peer Mentors (pre- and post-involvement in study).
Time frame: Baseline & End of Study at 12 Months 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). The total DDS-T1 score is calculated by averaging the items . Min possible total score = 1, Max = 6. Higher scores = more diabetes distress; average score \<2.0 = little/no distress, 2.0-2.9 = moderate distress, 3.0 or higher = high distress. Collected for young adult participants in both arms (baseline, 6 mo, 12 mo) and Peer Mentors (pre- and post-involvement in study).
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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 5 (always). A total score is calculated by summing the items, ranging from 4-20. Higher scores = more depressive symptoms. Collected for young adult participants in both arms, not Peer Mentors.
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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) . A total score is calculated by summing the items. The possible range is 4-20. Higher scores = more perceived emotional support. Collected for young adult participants in both arms, not Peer Mentors.
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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). A total score is calculated by summing the items. The possible range is 4-20. Higher scores = more perceived informational support. Collected for young adult participants in both arms, not Peer Mentors.
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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 equivalent to the total score (higher = more perceived isolation). Collected for young adult participants in both arms (baseline, 6, \& 12 mos), not Peer Mentors.
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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). For each subscale, a subscale score is calculated by averaging the items. Possible score range for each subscale = 1-5. Higher scores = higher readiness in each domain. Collected for young adult participants in both arms (baseline, 6, \& 12 mos), not Peer Mentors.
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months 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). A total score is calculated by summing the items. Possible score range = 5-35. Higher = greater overall satisfaction with life. Collected for young adult participants in both arms (baseline and 12 mo), not Peer Mentors.
Time frame: Baseline and End of Study at 12 Months Post-Randomization