Research design and baseline participant characteristics of the Resilient, Empowered, Active Living with Diabetes - Telehealth (REAL-T) Study: A randomized controlled trial for young adults with type 1 diabetes.

BACKGROUND: Type 1 diabetes (T1D) is a chronic condition affecting nearly 1.9 million people in the United States. Young adults (YAs) with T1D face unique challenges in managing their condition, experiencing poorer health and well-being than other age groups. The current study is evaluating the Resilient, Empowered, Active Living (REAL) intervention, previously shown to improve glucose levels and quality of life among YAs with diabetes, using telehealth delivery (REAL-T) to expand reach and accessibility. This paper reports on the methodology and baseline participant characteristics of the REAL-T study. METHODS: REAL-T is a two-arm randomized controlled trial that recruited 18-30 year olds with T1D via clinics and social media advertising. Data collection, which was adapted to be fully remote due to COVID-19, occurs every three months for one year. Participants receive either usual care or a 6-month telehealth occupational therapy intervention. The primary outcome is glycated hemoglobin (A1c); secondary outcomes include diabetes distress, quality of life, and continuous glucose monitor-derived measures. RESULTS: The study enrolled a diverse sample of 209 YAs with T1D. Analysis of baseline data indicates equivalence between the intervention and control groups. Study participants have notably higher diabetes distress and poorer mental well-being than similar populations. CONCLUSION: The REAL-T study successfully adapted to remote implementation during the COVID-19 pandemic. By examining long-term outcomes, mediating pathways, and cost-effectiveness, the study will contribute knowledge of the impact of tailored interventions for YAs with T1D, designed to reduce disparities and improve health and well-being in this population.

Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.

BACKGROUND/AIMS: Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients. METHODS: Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features. RESULTS: In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. CONCLUSIONS: Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.

Psychosocial and Behavioral Correlates of A1C and Quality of Life Among Young Adults With Diabetes.

PURPOSE: The purpose of this study was to evaluate relationships between behavioral and psychosocial constructs, A1C, and diabetes-dependent quality of life (DQoL) among low-socioeconomic status, ethnically diverse young adults with diabetes. METHODS: Using baseline data of 81 participants in the Resilient, Empowered, Active Living (REAL) randomized controlled trial, behavioral, cognitive, affective, and experiential variables were correlated with A1C and DQoL while adjusting for demographic characteristics, and these relationships were examined for potential effect modification. RESULTS: The data indicate that depressive symptoms and satisfaction with daily activities are associated with both A1C and DQoL, while diabetes knowledge and participation in daily activities are associated with neither A1C nor DQoL. Two constructs, diabetes distress and life satisfaction, were associated with DQoL and were unrelated to A1C, while 2 constructs, self-monitoring of blood glucose and medication adherence, were associated with A1C but unrelated to DQoL. These relationships were largely unchanged by adjusting for demographic characteristics, while numerous effect modifications were found. CONCLUSION: The data suggest that when tailoring interventions, depressive symptoms and satisfaction with daily activities may be particularly fruitful intervention targets, as they represent modifiable risk factors that are associated with both A1C and DQoL.

Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A1c [HbA1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests. RESULTS: Intent-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported. CONCLUSIONS: The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

OVERVIEW: This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. METHODS: In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. RESULTS: At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. DISCUSSION: Participants in the REAL study demonstrate clinically significant medical and psychosocial needs.

Clinical and Psychosocial Outcomes of a Structured Transition Program Among Young Adults With Type 1 Diabetes.

PURPOSE: We identified and treated young adults with type 1 diabetes who had been lost to follow-up during their transfer from pediatric to adult care, comparing their clinical, psychosocial, and health care utilization outcomes to participants receiving continuous care (CC) throughout the transition to adult care. METHODS: Individuals in their last year of pediatric care (CC group, n = 51) and individuals lost to follow-up in the transfer to adult care ("lapsed care" [LC] group, n = 24) were followed prospectively for 12 months. All participants were provided developmentally tailored diabetes education, case management, and clinical care through a structured transition program. RESULTS: At baseline, LC participants reported lapses in care of 11.6 months. Compared with CC participants, they had higher hemoglobin A1C (A1C; p = .005), depressive symptoms (p = .05), incidence of severe hypoglycemia (p = .005), and emergency department visits (p = .004). At 12-month follow-up, CC and LC participants did not differ on the number of diabetes care visits (p = .23), severe hypoglycemia (no events), or emergency department visits (p = .22). Both groups' A1C improved during the study period (CC: p = .03; LC: p = .02). LC participants' depressive symptoms remained elevated (p = .10), and they reported a decline in life satisfaction (p = .007). There was greater loss to follow-up in the LC group (p = .04). CONCLUSIONS: Our study suggests that, for young adults with a history of lapses in care, a structured transition program is effective in lowering A1C, reducing severe hypoglycemia and emergency department utilization, and improving uptake of routine diabetes care. Loss to follow-up and psychosocial concerns remain significant challenges in this population.

Let's Empower and Prepare (LEAP): Evaluation of a Structured Transition Program for Young Adults With Type 1 Diabetes.

OBJECTIVE: To evaluate the efficacy of a structured transition program compared with usual care in improving routine follow-up, clinical, and psychosocial outcomes among young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: Eighty-one young adults in their last year of pediatric care were recruited from three clinics. Intervention group (IG) participants (n = 51) received a structured transition program incorporating tailored diabetes education, case management, group education classes, and access to a newly developed young adult diabetes clinic and transition website. Control group (CG) participants (n = 30) received usual care. The primary outcome was the number of routine clinic visits. Secondary outcomes included glycemic control, hypoglycemia, health care use, and psychosocial well-being. Assessments were conducted at baseline, and 6 and 12 months. RESULTS: Limitations in CG follow-up prevented direct comparisons of adult care visits; however, at the 12-month follow-up among IG participants discharged from pediatric care (n = 32), 78% had one or more adult visits. Among IG participants, the total number of clinic visits did not differ between those who transitioned and those who remained in pediatric care (3.0 ± 1.24 vs. 3.11 ± 0.94, P = 0.74). IG compared with CG participants had improved glycemic control (-0.40 ± 1.16% vs. 0.42 ± 1.51% [4.4 ± 12.7 mmol/mol vs. 4.6 ± 16.5 mmol/mol], P = 0.01), incidence of severe hypoglycemia (0.0% vs. 16%, P = 0.02), and global well-being (P = 0.02) at 12 months. CONCLUSIONS: A structured transition program was successful in facilitating transition to adult care without a decrease in clinical follow-up. Compared with usual care, the transition program facilitated improvements in glycemic control, hypoglycemia, and psychosocial well-being.

Patient perspectives on peer mentoring: type 1 diabetes management in adolescents and young adults.

PURPOSE: The purpose of the study was to identify attitudes and topics relevant to peer mentoring as an adherence-promoting intervention for adolescents and young adults (YAs) with type 1 diabetes (T1D). METHODS: Self-administered survey data were collected in 2 diabetes clinics from a convenience sample of adolescents as prospective mentees (ages 13-18) and YAs as prospective mentors (ages 19-25) with T1D. Survey topics included demographics, disease history, glycemic control, adherence, depression, barriers to disease management, social support, and interest in peer mentoring. Descriptive statistical analyses, thematic coding, and stepwise multivariate logistic regression were performed. RESULTS: A majority of the 54 adolescents and 46 YAs expressed interest in a peer mentoring program. Having supportive friends and living in a large household positively predicted adolescent interest in having a peer mentor. Approximately one-third of all participants experienced social barriers to diabetes management. For adolescents, barriers included inflexible schedules, unfamiliar foods, and the embarrassment of checking blood glucose in front of others. Young adults reported barriers in tracking food consumption and remembering to check blood glucose. Various diabetes management skills were in high demand by adolescents, who especially desired to learn about managing T1D on their own and in college. Participants were open to multiple communication modes, including in-person meetings, phone, text messaging, and social media. CONCLUSIONS: Many adolescents and young adults with T1D are interested in peer mentoring as a way to facilitate learning and sharing essential diabetes management skills and experiences.

Continuous glucose monitoring pilot in low-income type 1 diabetes patients.

BACKGROUND: Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections. SUBJECTS AND METHODS: This was a single-center, prospective, randomized controlled, crossover pilot study. Initial focus groups were held to create low-literacy, Spanish and English guides to the use of carbohydrate counting and CGM. These tools were implemented to train participants on carbohydrate counting and insulin adjustments participants. Subjects were then randomized to start in Group A (CGM) or Group B (self-monitoring blood glucose and then switched after 28 weeks). Hemoglobin A1c (HbA1c) was obtained at baseline and at the end of both study phases. RESULTS: Twenty-five economically challenged, primarily Latino participants with minimal prior education on intensive diabetes management completed the study. No significant reduction in HbA1c or decrease in time spent in parameters of low and high blood glucose was shown. However, eighty percent of participants who completed the study wanted to continue to use CGM once the research study was over. The participants also felt that the CGM made adjusting insulin easier. CONCLUSIONS: CGM can be implemented in patients from a low-income public clinic; however, HbA1c reduction was not achieved. Given the underlying lack of baseline self-management knowledge, a longer trial might be necessary to see benefit with CGM in this population.