Acceptability of a Virtual Educational Intervention Targeted Towards Improving Diabetes Self- Efficacy and Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes Mellitus (T1DM): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acceptability of interactive virtual educational module no. 1
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: from 16 years to 21 years of age
- •Type 1 Diabetes Mellitus (Anti-body positive) for at least one year
- •Suboptimal glycemic control (HBA1C > 8.5%) in the last 6 months
- •Patients on insulin regimen involving multiple daily subcutaneous insulin injections (basal- bolus regimen) or insulin pumps (excluding hybrid close loop pumps)
排除标准
- •Non-English-Speaking patients
- •Patients on insulin regimen involving mixed insulin with twice daily injections
- •Patients who are planning to undergo any change in their insulin delivering technology or glucose monitoring device during the study time period i.e. planning initiation or discontinuation of pump or Continuous Glucose Meter.
- •Patients who received new onset DM teaching at another institution and transferred care from other institutions later in their disease course.
- •Individuals with other chronic medical conditions or underlying mental health conditions like eating disorders, schizophrenia or severe depression or inability to care for themselves in activities of daily living (ADLs), or impaired ability to participate in the research in the discretion of their primary diabetes provider.
- •Patients lacking accessibility of a virtual platform for the intervention modules for a 3-month
- •Patients with no visit with Diabetes care provider within the 6 months prior to screening for study eligibility
- •Pregnancy (only if subject, at the time of recruitment, reports being pregnant or planning a pregnancy in the next 6 months. Pregnancy tests will not be performed as part of the study).
结局指标
主要结局
Acceptability of interactive virtual educational module no. 1
时间窗: At completion of Module 1, at average of week 1
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 3
时间窗: At completion of Module 3, at average of week 3
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 6
时间窗: At completion of Module 6, at average of week 6
Score on Likert-based scale on feedback survey.
Attrition Rate
时间窗: At completion of entire educational intervention for all participants, an average of 3-5 months
Number of participants that did not complete the intervention divided by number of consenting participants
Acceptability of interactive virtual educational module no. 2
时间窗: At completion of Module 2, at average of week 2
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 5
时间窗: At completion of Module 5, at average of week 5
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 8
时间窗: At completion of Module 8, at average of week 8
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 10
时间窗: At completion of Module 10, at average of week 10
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 4
时间窗: At completion of Module 4, at average of week 4
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 7
时间窗: At completion of Module 7, at average of week 7
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 9
时间窗: At completion of Module 9, at average of week 9
Score on Likert-based scale on feedback survey.
Acceptability of interactive virtual educational module no. 11
时间窗: At completion of Module 11, at average of week 11
Score on Likert-based scale on feedback survey.
Overall acceptability of entire interactive virtual educational program
时间窗: At completion of Module 11, at average of week 11
Score on Likert-based scale on feedback survey.
Recruitment Rate
时间窗: At completion of recruitment of all participants, an average of 1 months
Number of consenting participants divided by number of eligible approached candidates
次要结局
- Change in participants' HBA1C(At baseline and at completion of entire educational intervention, an average of 3 months)
- Change in participants' diabetes related knowledge(At baseline and at completion of entire educational intervention, an average of 3 months)
- Change in participants' diabetes related distress(At baseline and 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.(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.(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.(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.(At completion of entire educational intervention, an average of 3 months)
- Change in subjective diabetes self-efficacy of participants(At baseline and at completion of entire educational intervention, an average of 3 months)
- Change in participants' Time In Range(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.(At completion of entire educational intervention, an average of 3 months)
研究者
Jamie Wood
Pediatric Endocrinologist
University Hospitals Cleveland Medical Center
