Acceptability of Virtual Educational Intervention for Adolescents and Young Adults With Type 1 Diabetes Mellitus

NCT04878419 | Completed

• 1 other identifier: STUDY20210264
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Self efficacy; Virtual; Education; Adolescents; Young adults

Outcome Measures

Primary Outcomes (14)

• Acceptability of interactive virtual educational module no. 1

  Score on Likert-based scale on feedback survey.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  At completion of recruitment of all participants, an average of 1 months

Secondary Outcomes (10)

• 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' 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

• Change in participants' Time In Range

  At baseline and at completion of entire educational intervention, an average of 3 months

• Change in participants' HBA1C

  At baseline and at completion of entire educational intervention, an average of 3 months

Other Outcomes (5)

• Correlation of childhood opportunity index (COI) with degree of change in participants' subjective diabetes self-efficacy after the educational intervention.

  At completion of entire educational intervention, an average of 3 months

• Correlation of childhood opportunity index (COI) with 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 childhood opportunity index (COI) with degree of change in participants' diabetes related distress after the educational intervention.

  At completion of entire educational intervention, an average of 3 months

Study Arms (1)

Virtual Educational Intervention

EXPERIMENTAL

Virtual Educational Intervention

Other: Virtual Educational Program

Interventions

Virtual Educational Program OTHER

Multiple virtual interactive sessions to provide education/knowledge about Type 1 Diabetes Mellitus care

Virtual Educational Intervention

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jamie Wood

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 7, 2021
• Study Start: June 17, 2021
• Primary Completion: January 20, 2022
• Study Completion: May 1, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)