Establishing fidelity for the creating opportunities for personal empowerment: Symptom and technology management resources (COPE-STAR) intervention.

AIM: To establish intervention fidelity for the Creating Opportunities for Personal Empowerment: Symptom and Technology Management Resources web-based intervention to assist caregivers of children aged 1-5 years in managing their child's symptoms and medical technology of tracheostomies and feeding tubes at home. DESIGN: Descriptive study of the strategies used to establish intervention fidelity, specifically using expert and caregiver reviewers. METHODS: To establish fidelity of the intervention, experts and caregivers were asked to evaluate the usefulness, ease of use, and acceptability of the intervention and provide any suggestions for the modules. Caregivers provided caregiver and child characteristics and were administered a health literacy measure, the Newest Vital Sign. Intervention fidelity was established from April 2019-July 2019. RESULTS/FINDINGS: Expert and caregiver reviewers (N = 13) all agreed or strongly agreed that the intervention was useful, easy to use, and acceptable. In addition, caregiver reviewers provided care to children who required multiple technologies and a variety of care needs at home and confirmed adequate health literacy (N = 5). CONCLUSION: The use of expert and caregiver reviewers was very beneficial in establishing intervention fidelity. Caregivers are experts in the care of their child and provide valuable feedback based on their daily experiences at home. Experts provided evidence-based feedback. IMPACT: This nursing intervention addresses caregivers of children who require medical technology by targeting caregiver management for common symptoms, related technologies, and resources for the child and caregiver in the home setting. Intervention fidelity was established and expert and caregiver reviewers confirmed the usefulness, ease of use, and acceptability of the intervention. This study is essential to nursing, other healthcare providers, and healthcare systems in planning and implementing programmes and services for children and their caregivers and for nurse researchers establishing intervention fidelity. TRIAL REGISTRATION: This study is not designated as a clinical trial per NIH/NINR study and grant proposal guidelines.

Mediators of 12-month outcomes of two Internet interventions for youth with type 1 diabetes.

OBJECTIVE: To determine mediators of 12-month outcomes of Internet interventions for youth with type 1 diabetes transitioning to adolescence. METHODS: In this multisite clinical trial, 320 youth were randomized to one of two Internet-based interventions: Coping skills (TEENCOPE™) or diabetes education (Managing Diabetes). Mediators of the interventions' effects on glycosylated hemoglobin and quality of life were examined. Data were collected at baseline and at 3, 6, and 12 months. RESULTS: Self-efficacy mediated treatment effects on quality of life in both interventions. For TEENCOPE™, stress reactivity, primary control coping, and secondary control coping mediated treatment effects, whereas for Managing Diabetes, social acceptance mediated treatment effects. There were no significant effects of either intervention on glycosylated hemoglobin. CONCLUSIONS: 2 Internet interventions for youth with type 1 diabetes resulted in improved quality of life by different mechanisms, suggesting components of both diabetes education and coping skills may help to achieve better outcomes in youth with type 1 diabetes.

Internet psycho-education programs improve outcomes in youth with type 1 diabetes.

OBJECTIVE: The purpose of this study was to determine the efficacy of two Internet-based psycho-educational programs designed to improve outcomes for youth with type 1 diabetes transitioning to adolescence. RESEARCH DESIGN AND METHODS: The study was a multisite clinical trial of 320 youth (aged 11-14 years; 37% minority; 55% female) randomized to one of two Internet-based interventions: TeenCope or Managing Diabetes. Primary outcomes were HbA1c and quality of life (QOL). Secondary outcomes included coping, self-efficacy, social competence, self-management, and family conflict. Data were collected at baseline and after 3, 6, and 12 months online. Youth were invited to cross over to the other program after 12 months, and follow-up data were collected at 18 months. Analyses were based on mixed models using intent-to-treat and per-protocol procedures. RESULTS: Youth in both groups had stable QOL and minimal increases in HbA1c levels over 12 months, but there were no significant differences between the groups in primary outcomes. After 18 months, youth who completed both programs had lower HbA1c (P = 0.04); higher QOL (P = 0.02), social acceptance (P = 0.01), and self-efficacy (P = 0.03) and lower perceived stress (P = 0.02) and diabetes family conflict (P = 0.02) compared with those who completed only one program. CONCLUSIONS: Internet interventions for youth with type 1 diabetes transitioning to adolescence result in improved outcomes, but completion of both programs was better than only one, suggesting that these youth need both diabetes management education and behavioral interventions. Delivering these programs via the Internet represents an efficient way to reach youth and improve outcomes.

Type 1 diabetes eHealth psychoeducation: youth recruitment, participation, and satisfaction.

BACKGROUND: The Internet and other eHealth technologies offer a platform for improving the dissemination and accessibility of psychoeducational programs for youth with chronic illness. However, little is known about the recruitment process and yield of diverse samples in Internet research with youth who have a chronic illness. OBJECTIVE: The purpose of this study was to compare the demographic and clinical characteristics of youth with Type 1 diabetes on recruitment, participation, and satisfaction with 2 eHealth psychoeducational programs. METHODS: Youth with Type 1 diabetes from 4 sites in the United States were invited to participate (N=510) with 320 eligible youth consenting (mean age=12.3, SD 1.1; 55.3% female; 65.2% white; and mean A1C=8.3, SD 1.5). Data for this secondary analysis included demographic information (age, race/ethnicity, and income), depressive symptoms, and recruitment rates, including those who refused at point of contact (22.0%), passive refusers who consented but did not participate (15.3%), and those who enrolled (62.7%). Participation (80% lessons completed) and a satisfaction survey (ie, how helpful, enjoyable) were also analyzed. Chi-square or analysis of variance (ANOVA) analyses were used. RESULTS: There were significant differences in recruitment rates by income and race/ethnicity such that black, Hispanic, or mixed race/ethnicity and low-income youth were more likely to refuse passively compared to white and higher-income youth who were more likely to enroll (P<.001). Participation in program sessions was high, with 78.1% of youth completing at least 4 of 5 sessions. There were no significant differences in participation by program, age, gender, or race/ethnicity. Low-income youth were less likely to participate (P=.002). Satisfaction in both programs was also high (3.9 of 5). There were significant gender, race/ethnicity, and income differences, in that girls (P=.001), black, Hispanic, or mixed race/ethnicity youth (P=.02), and low-income youth (P=.02) reported higher satisfaction. There were no differences in satisfaction by program or age. CONCLUSIONS: Results indicate that black, Hispanic, or mixed race/ethnicity youth and low-income youth with Type 1 diabetes are less likely to enroll in Internet-based research than white and higher-income youth; thus, creative recruitment approaches are needed. Low-income youth were less likely to participate, possibly due to access. However, once enrolled, youth of diverse race/ethnicity and low-income youth with Type 1 diabetes were as highly satisfied with the eHealth programs as white youth and those with higher income. Results suggest that eHealth programs have the potential to reach diverse youth and be appealing to them.

An internet coping skills training program for youth with type 1 diabetes: six-month outcomes.

BACKGROUND: Managing Type 1 diabetes (T1D) during adolescence can be challenging, and there is a need for accessible interventions to help adolescents cope with diabetes-related stress. OBJECTIVES: The aim of this study was to compare an Internet coping skills training (TEENCOPE) intervention to an Internet educational intervention (Managing Diabetes) for adolescents with T1D. Moderators of program efficacy were evaluated. METHODS: The study was a multisite clinical trial (n = 320) with data collected at baseline, 3 months, and 6 months. Data were collected on the primary outcomes of physiologic (A1C) and psychosocial (quality of life) and on the secondary outcomes of behavioral (self-management) and psychosocial (stress, coping self-efficacy, social competence, family conflict) variables consistent with the conceptual framework. Data were analyzed using mixed-model analyses with an intent-to-treat approach. RESULTS: There were no significant between-group treatment effects 6 months postintervention on primary outcomes. The Managing Diabetes youth showed a significant increase in social competence compared to the TEENCOPE youth. There were significant time effects for TEENCOPE (decreased stress and increased coping) and Managing Diabetes (improved diabetes quality of life). DISCUSSION: Youth with T1D transitioning to adolescence may need both structured diabetes education and coping skills to improve health outcomes. There may be a higher potential to reach adolescents with Type 1 diabetes of varying race and ethnicity via Internet interventions.

A comparison of two internet programs for adolescents with type 1 diabetes: design and methods.

Implementing psycho-educational programs for youth with type 1 diabetes in clinical care and reaching diverse youth with type 1 diabetes is challenging due to youth, provider, and organizational barriers. This study was designed to compare the effectiveness of an internet coping skills training program with a control condition of internet diabetes education. Each program consists of 5 weekly interactive lessons; the coping skills training program also provides the ability for youth to interact with each other as well as a health coach. Approximately 300 youths with type 1 diabetes will be recruited to participate in this multi-site clinical trial. The primary outcomes are metabolic control, quality of life, and family conflict. Secondary outcomes include stress, coping, self-efficacy, and social competence. Usage, satisfaction, and cost will also be evaluated. In addition, mediators and moderators to intervention effects will be explored. An internet based psycho-educational program for youth with type 1 diabetes may be a promising approach that can be easily be integrated into clinical care.

Coping, self-management, and adaptation in adolescents with type 1 diabetes.

BACKGROUND: Adolescents with type 1 diabetes experience stress related to treatment management, feeling different from peers, and deciding to tell others about their diabetes. PURPOSE: This study examined the relationship of stress reactivity and coping with self-management, quality of life, and metabolic control in an ethnically diverse sample of adolescents with type 1 diabetes. METHODS: Adolescents (n = 327) completed measures of coping and stress reactivity, self-management, and quality of life. Glycosylated hemoglobin data were collected from medical records. RESULTS: Low-income and minority status were related to lower levels of primary control coping (e.g., problem solving) and secondary control coping (e.g., acceptance), and higher levels of disengagement coping (e.g., avoidance). Self-management mediated the relationship between coping and stress reactivity with quality of life and metabolic control. Race/ethnicity and income moderated the relationship between coping and self-management goals. CONCLUSIONS: Results indicate differences in coping related to income and race/ethnicity and demonstrate the impact of coping on self-management and health outcomes in adolescents with type 1 diabetes.

Cardiorespiratory fitness and physical activity in youth with type 2 diabetes.

OBJECTIVE: The increased incidence of type 2 diabetes (T2D) among youth is hypothesized to be due, in part, to low levels of fitness and activity. Therefore, the purpose of this investigation was to examine whether cardiorespiratory fitness and physical activity are reduced in youth with T2D compared with overweight controls. PARTICIPANTS: Thirteen adolescent boys with previously diagnosed T2D (mean duration 2.4 +/- 1.8 yr) were matched for age and body mass index to 13 overweight, non-diabetic controls. METHODS: Cardiorespiratory fitness was assessed during a progressive exercise test to volitional fatigue and physical activity was estimated from a 7-d physical activity recall. RESULTS: Youth with T2D reported performing approximately 60% less moderate to vigorous physical activity compared with their non-diabetic counterparts (0.6 +/- 0.2 vs. 1.4 +/- 0.3 h/d, p = 0.04). Furthermore, diabetic youth exhibited significantly lower cardiorespiratory fitness levels compared with controls (28.7 +/- 1.6 vs. 34.6 +/- 2.2 mL/kg/min, p < 0.05). CONCLUSIONS: These findings support the hypothesis that cardiorespiratory fitness and physical activity are reduced in youth with T2D. Whether reduced fitness and activity contributed to the pathophysiology of the disorder cannot be determined from the cross-sectional analysis. Longitudinal studies are warranted to examine whether improvements in fitness and increased physical activity can prevent the development of T2D in high-risk youth.