In this pilot study, study investigators aim to evaluate the acceptability and feasibility of a 3-month interactive virtual educational program, designed on principles of self-efficacy, reviewing aspects of Diabetes Mellitus care in adolescents and young adults with Type 1 Diabetes Mellitus (T1DM). Secondarily, investigators also aim to evaluate the effect of the educational program on participants subjective diabetes self-efficacy, diabetes related knowledge, diabetes distress as well as glycemic control. Population size: Fifteen (15) patients will be recruited and enrolled in this study. Study Design: This is a pilot acceptability and feasibility study with a prospective design to evaluate the effect of the educational intervention on multiple endpoints. Study Duration: Participants will complete educational intervention over duration of 3 months after which their glycemic control data will be retrieved from the first clinic visit post intervention (within 5 months of completion of the intervention). Hence, The overall study duration is approximately \>3 to 9 months.
Background/Rationale: The landmark study Diabetes Control and Complications Trial (DCCT, 1982-1993) conclusively proved that intensive glycemic control causes a reduction in the early stages of all microvascular complications of Type 1 Diabetes Mellitus. The durability of the impact of intensive glycemic control in reducing long term microvascular as well as macro vascular complications of T1DM was further endorsed by the observational follow up study 'Epidemiology of Diabetes Interventions and Complications (EDIC). (1) Intensive glycemic control has since become the primary clinical goal to ensure a healthy, long life for patients with T1DM. In clinical practice, this is truly a challenge. Particularly in pediatric patients, metabolic control worsens during adolescence in both sexes. (2) Physiologic increase in insulin resistance during puberty partly plays a role, but research has shown that psychosocial factors like family functioning, coping skills, depression/anxiety contribute to metabolic control in adolescence. (3,4) Unfortunately, this worsening of metabolic control continues into young adulthood. Glycemic control substantially declines amongst T1D patients in the age range for transition to adult care, with mean HbA1C at its peak of 9.2% at age 19 years after which the glycemic control gradually improves. (5) Of note, between the ages 18-25 years of age, only 14% of patients were shown to meet American Diabetes Association(ADA) HbA1c targets from the updated data from the T1D Exchange Clinic Registry. (5) T1DM is a chronic lifelong illness that requires self-management on a daily basis. Despite technological leaps in the insulin delivery and blood glucose monitoring devices, self-management remains vital to diabetes mellitus care. Undoubtedly, closed loop systems have taken away the need for frequent Self-Monitoring of Blood Glucose and insulin dose administrations and adjustments, this technology is still fairly new, not universally available, is not personally preferred universally and continues to require awareness of the technological issues and participation in other aspects of Diabetes Mellitus (DM) self-care like diet and exercise. This self-management role transitions from parent-dominant to shared management to adolescent dominant management over the course of adolescence period. (6) This age group is of particular interest for self-efficacy enhancement studies as the adolescents will soon transition to adulthood and more or less independent self-care. Self- efficacy is one's beliefs about ability to achieve a goal. Metabolic control is affected by perceived self-efficacy to conduct self-care. (7) Self-efficacy beliefs are influenced by mastery, imaginal, vicarious experiences as well as physiological states and social persuasion. (8) Cultivation of positive self-efficacy is very important as it not only influences task performance but also plays a role in coping. (8) Strategies to improve glycemic control remains an area of interest for clinicians and researchers. In a meta-analysis of ten randomized control trials, Winkley et al concluded that psychological treatments can slightly improve glycemic control in children. (9) Other studies have shown that adherence to treatment regimen is linked to better glycemic control. (10) Literature is rampant with adherence promoting behavioral interventions to positively affect the diabetes self-management. Some examples include motivational/solution-focused group intervention (11), coping skills training (12), family-focused teamwork (TW) intervention (13), diabetes personal trainer" intervention, consisting of self-monitoring, goal-setting, and problem-solving sessions with trained nonprofessionals (14). Meta-analysis of fifteen (randomized control trials (RCTs) that employed adherence promoting behavioral interventions concluded that there is only a modest improvement in glycemic control with significant variability between different interventions. (15) Unfortunately, most of these interventions are costly, time consuming and not practical for long term maintenance and employment in a clinical setting. Interventions that keep in consideration the concept of reach, efficacy, adoption, implementation, maintenance (RE-AIM) are required. (16) To tackle these issues, investigators plan to study virtual interventions employing telehealth services. Telehealth videoconferencing has the potential to improve care in pediatric diabetes patients by increasing visits. (17) Studies have shown that patients' glycemic control remained stable and there was no increase in Diabetic Ketoacidosis (DKA), Emergency Department (ED) or hospital visits and satisfaction was equal to in-person visits with telehealth. (18) Virtual access is more stream- lined, overcomes the challenge of time and resources needed on part of patient. Particularly, during the uncertain times of the Coronavirus disease-19 (COVID-19) pandemic, virtual programs can serve a vital role. The study findings can be used to construct a virtual structured transition of care program for youth with Type 1 Diabetes Mellitus which is more accessible and time-flexible for patient needs. Study Objectives: 1. To evaluate the acceptability and feasibility of a 3-month interactive virtual educational program, designed on principles of self-efficacy, reviewing aspects of Diabetes Mellitus care in adolescents and young adults with Type 1 Diabetes Mellitus. 2. To evaluate the effect of the educational program on participants subjective diabetes self-efficacy, diabetes related knowledge, diabetes distress as well as glycemic control. 3. To evaluate the effect of outcome expectation on degree of change in participants subjective diabetes self-efficacy, diabetes related knowledge, diabetes distress as well as glycemic control after the educational intervention. 4. To evaluate the association of childhood opportunity index with the impact of the educational intervention Study Hypotheses: * Investigators hypothesize that the participants will have improvement in their subjective diabetes self-efficacy, diabetes knowledge scores, diabetes distress as well as their glycemic control (measured by percent change in HbA1C and Time in Range data) post-completion of intervention. * Investigator also hypothesize that participants with positive outcome expectation for the virtual education program and with a higher childhood opportunity score will have greater improvement in their subjective diabetes self- efficacy, diabetes related distress, diabetes knowledge scores and glycemic control post intervention. Study Design: This is a pilot acceptability and feasibility study with a prospective design to evaluate the effect of the educational intervention on multiple endpoints.The overall study duration is approximately \>3 to 9 months. Pre-Intervention Procedures: The following surveys will be administered to the participants at the pre-intervention encounter: 1. A baseline survey about patient's characteristics and diabetes management data. 2. Diabetes Self Efficacy survey 3. Diabetes related Distress survey 4. Diabetes Knowledge survey 5. Survey for Outcome expectation for the intervention Glycemic control data (HBA1C and Time in Range) will be retrieved from the patient's medical chart from the clinic visit prior to consenting for the study. Intervention Procedures: Weekly virtual and interactive educational sessions will be administered by the PI. There are total 11 sessions. Each session is about 15-20 minutes. These sessions will be administered through secure tele-health media Doxy.me. At the end of each module, feedback surveys will be administered. Broadly, the educational sessions will cover topics including Type 1 Diabetes pathophysiology, management of T1DM and complications of Hypoglycemia and Hyperglycemia, Types of Insulin, available Diabetes technology and utilizing blood glucose data for T1DM management, Sick day management, diabetes related complications, practical life issues during transition to adulthood including insurance, medications and supplies management, driving, dating and impact of drinking and drugs on T1DM management. These modules will also cover anticipated issues during transition to college or to workplace and guidance to mitigate the issues. Post-Intervention Procedures: At the completion of the entire 3 month educational program, following surveys will be administered. 1. Feedback survey for the entire educational program. 2. Diabetes Self Efficacy survey 3. Diabetes related Distress survey 4. Diabetes Knowledge survey Glycemic control data (HBA1C and Time in Range) will be retrieved from the patient's medical chart from the 1st clinic visit after completion of the entire educational program ( within five months of completion of the intervention).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Multiple virtual interactive sessions to provide education/knowledge about Type 1 Diabetes Mellitus care
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Acceptability of interactive virtual educational module no. 1
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 1, at average of week 1
Acceptability of interactive virtual educational module no. 2
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 2, at average of week 2
Acceptability of interactive virtual educational module no. 3
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 3, at average of week 3
Acceptability of interactive virtual educational module no. 4
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 4, at average of week 4
Acceptability of interactive virtual educational module no. 5
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 5, at average of week 5
Acceptability of interactive virtual educational module no. 6
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 6, at average of week 6
Acceptability of interactive virtual educational module no. 7
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 7, at average of week 7
Acceptability of interactive virtual educational module no. 8
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 8, at average of week 8
Acceptability of interactive virtual educational module no. 9
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 9, at average of week 9
Acceptability of interactive virtual educational module no. 10
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 10, at average of week 10
Acceptability of interactive virtual educational module no. 11
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 11, at average of week 11
Overall acceptability of entire interactive virtual educational program
Score on Likert-based scale on feedback survey.
Time frame: At completion of Module 11, at average of week 11
Attrition Rate
Number of participants that did not complete the intervention divided by number of consenting participants
Time frame: At completion of entire educational intervention for all participants, an average of 3-5 months
Recruitment Rate
Number of consenting participants divided by number of eligible approached candidates
Time frame: At completion of recruitment of all participants, an average of 1 months
Change in subjective diabetes self-efficacy of participants
Comparison of pre and post intervention scores on Diabetes Empowerment Scale (Short form)- likert based scale
Time frame: At baseline and at completion of entire educational intervention, an average of 3 months
Change in participants' diabetes related knowledge
Comparison of pre and post intervention scores on Diabetes knowledge test (assessed through percent correct answers on an multiple choice test)
Time frame: At baseline and at completion of entire educational intervention, an average of 3 months
Change in participants' diabetes related distress
Comparison of pre and post intervention scores on likert based scale called Problem Areas in Diabetes Scale (for 20 to 21 years old participants) and Problem Areas in Diabetes- Teen Scale (for 16-19 years old participants).
Time frame: At baseline and at completion of entire educational intervention, an average of 3 months
Change in participants' Time In Range
Comparison of pre and post intervention Time in Range data from Continuous Glucose monitor.
Time frame: At baseline and at completion of entire educational intervention, an average of 3 months
Change in participants' HBA1C
Comparison of pre and post intervention HBA1C
Time frame: At baseline and at completion of entire educational intervention, an average of 3 months
Correlation of outcome expectation on degree of change in participants subjective diabetes self-efficacy after the educational intervention.
Outcome Expectation evaluated with a survey consisting of 5 questions.
Time frame: At completion of entire educational intervention, an average of 3 months
Correlation of outcome expectation on degree of change in participants diabetes related knowledge after the educational intervention.
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Outcome Expectation evaluated with a survey consisting of 5 questions.
Time frame: At completion of entire educational intervention, an average of 3 months
Correlation of outcome expectation on degree of change in participants diabetes related distress after the educational intervention.
Outcome Expectation evaluated with a survey consisting of 5 questions.
Time frame: At completion of entire educational intervention, an average of 3 months
Correlation of outcome expectation on degree of change in participants HBA1C after the educational intervention.
Outcome Expectation evaluated with a survey consisting of 5 questions.
Time frame: At completion of entire educational intervention, an average of 3 months
Correlation of outcome expectation on degree of change in participants Time in Range after the educational intervention.
Outcome Expectation evaluated with a survey consisting of 5 questions.
Time frame: At completion of entire educational intervention, an average of 3 months