Type 1 Diabetes
Conditions
Keywords
Peer Support, Adherence, Young Adult, Quality of Life, Transition, Resilience, Strengths-based, Sleep, COVID-19 Experiences
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.
Interventions
BEHAVIORALDiaBetter Together
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).
BEHAVIORALPeer Mentor Delivery
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's National Research Institute
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be aware of their assignment to intervention or control, as will the investigators. However, the person collecting HbA1c (primary outcome) at baseline and follow-up (12 mo) will not be aware of the participant's assignment in the intervention.
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.
Eligibility
Sex/Gender
ALL
Age
17 Years to 35 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (HbA1c) | Baseline through 12-Month Post-Randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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). |
| Health-Related Quality of Life (Type 1 Diabetes and Life) | Baseline and End of Study at 12 Months Post-Randomization | 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). |
| Diabetes Strengths (Diabetes Strengths and Resilience Measure) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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. |
| Social Support (Brief 2-Way Social Support Scale) | Baseline & End of Study at 12 Months Post-Randomization | 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). |
| Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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 to First Adult Care Visit | End of Study at 12 Months Post-Randomization | 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. |
| Emotional Support (PROMIS Short Form Emotional Support 4a) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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. |
| Informational Support (PROMIS Short Form Informational Support 4a) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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. |
| Social Isolation (PROMIS Short Form Social Isolation Item) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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. |
| Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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. |
| General Quality of Life (Satisfaction With Life Scale) | Baseline and End of Study at 12 Months Post-Randomization | 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. |
| Depressive Symptoms (PROMIS Short Form Depression 4a) | Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization | 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. |
Countries
United States
Participant flow
Recruitment details
115 young adults consented to the trial. Of those, 14 did not complete baseline data and were therefore not randomized, and 1 was withdrawn due to a change in eligibility. 29 peer mentors consented to the trial and completed baseline data.
Pre-assignment details
Results reflect the number of participants who completed data. This differs from the protocol enrollment number, as some consented participants did not complete baseline data and thus were not randomized or followed for subsequent data collection. Following trial completion, a subset of 20 participants from the Usual Care group completed an additional week of data collection related to their experiences with sleep. No intervention was administered - data collection only.
Participants by arm
| Arm | Count |
|---|---|
| DiaBetter Together Intervention 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. | 50 |
| Usual Care 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. | 50 |
| Peer Mentors 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. | 29 |
| Total | 129 |
Baseline characteristics
| Characteristic | DiaBetter Together Intervention | Peer Mentors | Total | Usual Care |
|---|---|---|---|---|
| Age, Continuous | 20.0 Years STANDARD_DEVIATION 1.3 | 25.1 Years STANDARD_DEVIATION 3.3 | 21.1 Years STANDARD_DEVIATION 2.9 | 19.9 Years STANDARD_DEVIATION 1.3 |
| Continuous glucose monitor use, self-reported | 42 Participants | 27 Participants | 103 Participants | 34 Participants |
| Insulin delivery method, self-reported Injections | 23 Participants | 4 Participants | 48 Participants | 21 Participants |
| Insulin delivery method, self-reported Insulin Pump | 27 Participants | 25 Participants | 81 Participants | 29 Participants |
| Insurance Private or Commercial | 27 Participants | 27 Participants | 80 Participants | 26 Participants |
| Insurance Public, County, Other, or No Insurance | 18 Participants | 2 Participants | 36 Participants | 16 Participants |
| Insurance Unsure | 5 Participants | 0 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Race and Ethnicity African American/Black, non-Hispanic | 8 Participants | 1 Participants | 13 Participants | 4 Participants |
| Race/Ethnicity, Customized Race and Ethnicity American Indian/Alaska Native, non-Hispanic | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Another or multiple | 3 Participants | 0 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian, non-Hispanic | 1 Participants | 2 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Hispanic | 8 Participants | 6 Participants | 31 Participants | 17 Participants |
| Race/Ethnicity, Customized Race and Ethnicity White, non-Hispanic | 29 Participants | 20 Participants | 74 Participants | 25 Participants |
| Sex: Female, Male Female | 33 Participants | 21 Participants | 79 Participants | 25 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 50 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 29 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 29 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 29 | 0 / 50 |
Outcome results
Primary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Glycemic Control (HbA1c) | Baseline | 9.1 Percentage of HbA1c | Standard Deviation 2 |
| DiaBetter Together Intervention | Glycemic Control (HbA1c) | End of Study at 12 Months Post-Randomization | 9.2 Percentage of HbA1c | Standard Deviation 2.3 |
| Peer Mentors | Glycemic Control (HbA1c) | Baseline | 6.5 Percentage of HbA1c | Standard Deviation 0.7 |
| Usual Care | Glycemic Control (HbA1c) | Baseline | 8.5 Percentage of HbA1c | Standard Deviation 2 |
| Usual Care | Glycemic Control (HbA1c) | End of Study at 12 Months Post-Randomization | 8.6 Percentage of HbA1c | Standard Deviation 1.9 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Depressive Symptoms (PROMIS Short Form Depression 4a) | Baseline | 7.3 scores on a scale | Standard Deviation 4.2 |
| DiaBetter Together Intervention | Depressive Symptoms (PROMIS Short Form Depression 4a) | 6 months | 6.0 scores on a scale | Standard Deviation 3.1 |
| DiaBetter Together Intervention | Depressive Symptoms (PROMIS Short Form Depression 4a) | End of Study at 12 Months Post-Randomization | 7.1 scores on a scale | Standard Deviation 4 |
| Peer Mentors | Depressive Symptoms (PROMIS Short Form Depression 4a) | Baseline | 7.2 scores on a scale | Standard Deviation 3.6 |
| Peer Mentors | Depressive Symptoms (PROMIS Short Form Depression 4a) | 6 months | 8.0 scores on a scale | Standard Deviation 4.1 |
| Peer Mentors | Depressive Symptoms (PROMIS Short Form Depression 4a) | End of Study at 12 Months Post-Randomization | 7.5 scores on a scale | Standard Deviation 4.2 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition~1 missing value at baseline due to scoring rules, unable to calculate a total score due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | 6 months | 1.8 scores on a scale | Standard Deviation 0.8 |
| DiaBetter Together Intervention | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | Baseline | 2.3 scores on a scale | Standard Deviation 1 |
| DiaBetter Together Intervention | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | End of Study at 12 Months Post-Randomization | 1.7 scores on a scale | Standard Deviation 0.7 |
| Peer Mentors | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | 6 months | 2.0 scores on a scale | Standard Deviation 0.7 |
| Peer Mentors | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | Baseline | 2.0 scores on a scale | Standard Deviation 0.7 |
| Peer Mentors | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | End of Study at 12 Months Post-Randomization | 2.0 scores on a scale | Standard Deviation 0.8 |
| Usual Care | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | End of Study at 12 Months Post-Randomization | 1.8 scores on a scale | Standard Deviation 0.6 |
| Usual Care | Diabetes Distress (Diabetes Distress Scale for Adults With T1D) | Baseline | 1.8 scores on a scale | Standard Deviation 0.6 |
Secondary
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).
Time frame: Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | 6 months | 4.0 scores on a scale | Standard Deviation 0.7 |
| DiaBetter Together Intervention | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | Baseline | 3.8 scores on a scale | Standard Deviation 0.7 |
| DiaBetter Together Intervention | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | End of Study at 12 Months Post-Randomization | 3.9 scores on a scale | Standard Deviation 0.7 |
| Peer Mentors | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | 6 months | 3.9 scores on a scale | Standard Deviation 0.7 |
| Peer Mentors | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | Baseline | 4.0 scores on a scale | Standard Deviation 0.6 |
| Peer Mentors | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | End of Study at 12 Months Post-Randomization | 3.9 scores on a scale | Standard Deviation 0.6 |
| Usual Care | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | End of Study at 12 Months Post-Randomization | 4.1 scores on a scale | Standard Deviation 0.5 |
| Usual Care | Diabetes Self-Management/Adherence (Self-Care Inventory-Updated) | Baseline | 4.1 scores on a scale | Standard Deviation 0.5 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Diabetes Strengths (Diabetes Strengths and Resilience Measure) | Baseline | 50.4 scores on a scale | Standard Deviation 10.1 |
| DiaBetter Together Intervention | Diabetes Strengths (Diabetes Strengths and Resilience Measure) | 6 months | 52.1 scores on a scale | Standard Deviation 9.2 |
| DiaBetter Together Intervention | Diabetes Strengths (Diabetes Strengths and Resilience Measure) | End of Study at 12 Months Post-Randomization | 52.8 scores on a scale | Standard Deviation 8.6 |
| Peer Mentors | Diabetes Strengths (Diabetes Strengths and Resilience Measure) | Baseline | 50.0 scores on a scale | Standard Deviation 9.3 |
| Peer Mentors | Diabetes Strengths (Diabetes Strengths and Resilience Measure) | 6 months | 49.7 scores on a scale | Standard Deviation 9.4 |
| Peer Mentors | Diabetes Strengths (Diabetes Strengths and Resilience Measure) | End of Study at 12 Months Post-Randomization | 50.1 scores on a scale | Standard Deviation 10.4 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Emotional Support (PROMIS Short Form Emotional Support 4a) | Baseline | 16.7 scores on a scale | Standard Deviation 4.3 |
| DiaBetter Together Intervention | Emotional Support (PROMIS Short Form Emotional Support 4a) | 6 months | 17.5 scores on a scale | Standard Deviation 3.1 |
| DiaBetter Together Intervention | Emotional Support (PROMIS Short Form Emotional Support 4a) | End of Study at 12 Months Post-Randomization | 17.6 scores on a scale | Standard Deviation 2.7 |
| Peer Mentors | Emotional Support (PROMIS Short Form Emotional Support 4a) | Baseline | 16.8 scores on a scale | Standard Deviation 3.8 |
| Peer Mentors | Emotional Support (PROMIS Short Form Emotional Support 4a) | 6 months | 16.8 scores on a scale | Standard Deviation 3.7 |
| Peer Mentors | Emotional Support (PROMIS Short Form Emotional Support 4a) | End of Study at 12 Months Post-Randomization | 16.4 scores on a scale | Standard Deviation 3.8 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | General Quality of Life (Satisfaction With Life Scale) | Baseline | 23.1 scores on a scale | Standard Deviation 8.1 |
| DiaBetter Together Intervention | General Quality of Life (Satisfaction With Life Scale) | End of Study at 12 Months Post-Randomization | 24.0 scores on a scale | Standard Deviation 8.5 |
| Peer Mentors | General Quality of Life (Satisfaction With Life Scale) | Baseline | 24.0 scores on a scale | Standard Deviation 6.7 |
| Peer Mentors | General Quality of Life (Satisfaction With Life Scale) | End of Study at 12 Months Post-Randomization | 22. scores on a scale | Standard Deviation 6.8 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Health-Related Quality of Life (Type 1 Diabetes and Life) | Baseline | 65.5 scores on a scale | Standard Deviation 15.8 |
| DiaBetter Together Intervention | Health-Related Quality of Life (Type 1 Diabetes and Life) | End of Study at 12 Months Post-Randomization | 68.4 scores on a scale | Standard Deviation 16 |
| Peer Mentors | Health-Related Quality of Life (Type 1 Diabetes and Life) | Baseline | 66.7 scores on a scale | Standard Deviation 15.4 |
| Peer Mentors | Health-Related Quality of Life (Type 1 Diabetes and Life) | End of Study at 12 Months Post-Randomization | 63.0 scores on a scale | Standard Deviation 14.6 |
| Usual Care | Health-Related Quality of Life (Type 1 Diabetes and Life) | Baseline | 65.6 scores on a scale | Standard Deviation 12.5 |
| Usual Care | Health-Related Quality of Life (Type 1 Diabetes and Life) | End of Study at 12 Months Post-Randomization | 61.6 scores on a scale | Standard Deviation 14.5 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Informational Support (PROMIS Short Form Informational Support 4a) | Baseline | 16.2 scores on a scale | Standard Deviation 4 |
| DiaBetter Together Intervention | Informational Support (PROMIS Short Form Informational Support 4a) | 6 months | 17.2 scores on a scale | Standard Deviation 2.9 |
| DiaBetter Together Intervention | Informational Support (PROMIS Short Form Informational Support 4a) | End of Study at 12 Months Post-Randomization | 17.0 scores on a scale | Standard Deviation 3.5 |
| Peer Mentors | Informational Support (PROMIS Short Form Informational Support 4a) | Baseline | 15.9 scores on a scale | Standard Deviation 3.9 |
| Peer Mentors | Informational Support (PROMIS Short Form Informational Support 4a) | 6 months | 16.5 scores on a scale | Standard Deviation 3.4 |
| Peer Mentors | Informational Support (PROMIS Short Form Informational Support 4a) | End of Study at 12 Months Post-Randomization | 16.3 scores on a scale | Standard Deviation 4 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Social Isolation (PROMIS Short Form Social Isolation Item) | Baseline | 2.6 scores on a scale | Standard Deviation 1.3 |
| DiaBetter Together Intervention | Social Isolation (PROMIS Short Form Social Isolation Item) | 6 months | 2.2 scores on a scale | Standard Deviation 1.1 |
| DiaBetter Together Intervention | Social Isolation (PROMIS Short Form Social Isolation Item) | End of Study at 12 Months Post-Randomization | 2.5 scores on a scale | Standard Deviation 1.1 |
| Peer Mentors | Social Isolation (PROMIS Short Form Social Isolation Item) | Baseline | 2.5 scores on a scale | Standard Deviation 1.1 |
| Peer Mentors | Social Isolation (PROMIS Short Form Social Isolation Item) | 6 months | 2.8 scores on a scale | Standard Deviation 1.3 |
| Peer Mentors | Social Isolation (PROMIS Short Form Social Isolation Item) | End of Study at 12 Months Post-Randomization | 2.5 scores on a scale | Standard Deviation 1.3 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Social Support (Brief 2-Way Social Support Scale) | Baseline | 50.2 scores on a scale | Standard Deviation 7 |
| DiaBetter Together Intervention | Social Support (Brief 2-Way Social Support Scale) | End of Study at 12 Months Post-Randomization | 50.3 scores on a scale | Standard Deviation 7.9 |
| Peer Mentors | Social Support (Brief 2-Way Social Support Scale) | End of Study at 12 Months Post-Randomization | 47.1 scores on a scale | Standard Deviation 10 |
| Peer Mentors | Social Support (Brief 2-Way Social Support Scale) | Baseline | 46.5 scores on a scale | Standard Deviation 9 |
| Usual Care | Social Support (Brief 2-Way Social Support Scale) | Baseline | 52.1 scores on a scale | Standard Deviation 4.5 |
| Usual Care | Social Support (Brief 2-Way Social Support Scale) | End of Study at 12 Months Post-Randomization | 52.7 scores on a scale | Standard Deviation 5.4 |
Secondary
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
Population: Time to adult care visit was unable to be collected for most trial participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiaBetter Together Intervention | Time to First Adult Care Visit | 4.7 month | Standard Deviation 2.1 |
| Peer Mentors | Time to First Adult Care Visit | 7.7 month | Standard Deviation 2.9 |
Secondary
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
Population: Differences between total analyzed and analyzed at follow-ups is due to participant attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Knowledge Scale - 6 months | 4.3 scores on a scale | Standard Deviation 0.8 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Navigation Scale - End of Study at 12 Months Post-Randomization | 4.7 scores on a scale | Standard Deviation 0.5 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Navigation Scale - Baseline | 4.3 scores on a scale | Standard Deviation 0.6 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Health Behaviors Scale - Baseline | 4.8 scores on a scale | Standard Deviation 0.6 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Knowledge Scale - End of Study at 12 Months Post-Randomization | 4.4 scores on a scale | Standard Deviation 0.8 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Health Behaviors Scale - 6 months | 4.8 scores on a scale | Standard Deviation 0.4 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Navigation Scale - 6 months | 4.5 scores on a scale | Standard Deviation 0.6 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Health Behaviors Scale - End of Study at 12 Months Post-Randomization | 4.9 scores on a scale | Standard Deviation 0.4 |
| DiaBetter Together Intervention | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Knowledge Scale - Baseline | 3.9 scores on a scale | Standard Deviation 1 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Health Behaviors Scale - End of Study at 12 Months Post-Randomization | 4.6 scores on a scale | Standard Deviation 1.1 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Knowledge Scale - Baseline | 3.9 scores on a scale | Standard Deviation 1.1 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Knowledge Scale - 6 months | 4.0 scores on a scale | Standard Deviation 1.2 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Knowledge Scale - End of Study at 12 Months Post-Randomization | 4.0 scores on a scale | Standard Deviation 1.1 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Navigation Scale - Baseline | 4.3 scores on a scale | Standard Deviation 0.8 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Navigation Scale - 6 months | 4.3 scores on a scale | Standard Deviation 0.8 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Navigation Scale - End of Study at 12 Months Post-Randomization | 4.4 scores on a scale | Standard Deviation 0.7 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Health Behaviors Scale - Baseline | 4.7 scores on a scale | Standard Deviation 1 |
| Peer Mentors | Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) | Health Behaviors Scale - 6 months | 4.7 scores on a scale | Standard Deviation 0.9 |