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DiaBetter Together for Young Adults With Type 1 Diabetes (DiaBetter)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247620
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2020
Last Update Posted : June 10, 2022
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's National Research Institute
Information provided by (Responsible Party):
Marisa Hilliard, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: DiaBetter Together Behavioral: Peer Mentor Delivery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

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.
Primary Purpose: Supportive Care
Official Title: DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 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.
Behavioral: DiaBetter 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).

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.
Behavioral: Peer 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.

No Intervention: 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.
No Intervention: Research Supplement
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.



Primary Outcome Measures :
  1. Glycemic Control (HbA1c) [ Time Frame: 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, not Peer Mentors.



Secondary Outcome Measures :
  1. Time to First Adult Care Visit [ Time Frame: 12-Month 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.


  2. Diabetes Self-Management/Adherence (Self-Care Inventory-Revised, Short Form) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization ]

    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).


  3. Health-Related Quality of Life (Type 1 Diabetes and Life) [ Time Frame: Baseline and 12-Month 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) 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).


  4. Diabetes Strengths (Diabetes Strengths and Resilience measure) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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) and are calculated for total and subscale scores (higher = more strengths).

    Collected for young adult participants in both arms, not Peer Mentors.


  5. Social Support (Brief 2-Way Social Support Scale) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month Post-Randomization ]

    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).


  6. Diabetes Distress (Diabetes Distress Scale for Adults with T1D) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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) 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).


  7. Depressive Symptoms (PROMIS Short Form Depression 4a) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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 6 (always) and are calculated into a total score (higher = more depressive symptoms).

    Collected for young adult participants in both arms, not Peer Mentors.


  8. Emotional Support (PROMIS Short Form Emotional Support 4a) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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) and are calculated into a total score (higher = more perceived support).

    Collected for young adult participants in both arms, not Peer Mentors.


  9. Informational Support (PROMIS Short Form Informational Support 4a) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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) and are calculated into a total score (higher = more perceived support).

    Collected for young adult participants in both arms, not Peer Mentors.


  10. Social Isolation (PROMIS Short Form Social Isolation item) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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 calculated into a total score (higher = more perceived isolation).

    Collected for young adult participants in both arms (baseline, 6, & 12 mos), not Peer Mentors.


  11. Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth) [ Time Frame: Baseline, 6-Month Post-Randomization, & 12-Month 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) 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.


  12. General Quality of Life (Satisfaction with Life Scale) [ Time Frame: Baseline and 12-Month 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) 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.


  13. Subjective Sleep Experiences (Pittsburgh Sleep Quality Index - Revised) [ Time Frame: Baseline and 12-Month Post-Randomization ]

    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.


  14. COVID-19 Protective Behaviors (Oelsner MESA COVID-19 - Revised) [ Time Frame: Baseline and 12-Month Post-Randomization ]

    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).


  15. COVID-19 Experiences (COVID-19 Experiences Questionnaire for Young Adults with T1D) [ Time Frame: Baseline and 12-Month Post-Randomization ]
    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).

  16. Stressful Events (Stressful Event Questionnaire) [ Time Frame: Baseline and 12-Month Post-Randomization ]

    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.


  17. Social Vulnerability (CDC/ATSDR Social Vulnerability Index) [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247620


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's National Research Institute
Investigators
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Principal Investigator: Marisa E Hilliard, PhD Baylor College of Medicine
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Responsible Party: Marisa Hilliard, Associate Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04247620    
Other Study ID Numbers: H-45360
1R01DK119246 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants receive informed consent form, and other participant data is not returned to participant.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Receive copy of signed informed consent form upon signing
Access Criteria: All participants receive copy of signed informed consent form

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marisa Hilliard, Baylor College of Medicine:
Peer Support
Adherence
Young Adult
Quality of Life
Transition
Resilience
Strengths-based
Sleep
COVID-19 Experiences
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases