Acceptability of Virtual Educational Intervention for Adolescents and Young Adults With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Virtual Educational Program
Intervention type(s): Other
Intervention description(s): Multiple virtual interactive sessions to provide education/knowledge about Type 1 Diabetes Mellitus care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Self efficacy; Virtual; Education; Adolescents; Young adults