Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes

NCT03324438 | Completed

• 2 other identifiers: 17-0004DP3DK113363
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of regular contact with T1D care providers, continued T1D nonadherence, and suboptimal behavioral and mental health functioning compromises the physical health of youth with T1D and the ability of T1D teams to provide effective treatment. If the aims of this study are achieved, this study will change T1D care practices by providing high-risk youth with T1D, and their parents, medical and behavioral health support via home telehealth intervention. This has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, this study's use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.

Conditions

Type 1 Diabetes Mellitus

Keywords

pediatrics

Outcome Measures

Primary Outcomes (3)

• Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo)

  A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits. In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36). The rationale for measurement at these study visits is that they occur every 3 months, which is the interval in which A1C is measured as standard of care. Change in A1c will be looked at from baseline every 3 months throughout the study.

  weeks 1, 12, 24, 36, 48, 72

• Hyperglycemia - Change from baseline and every 12 weeks up to 72 weeks (18 mo)

  Time spent in hyperglycemia - change will be looked at from baseline every 12 weeks throughout the study.

  weeks 1, 12, 24, 36, 48, 72

• Pediatric Diabetes Quality of Life Scale - Change from baseline and every 12 weeks up to 72 weeks (18 mo)

  The PDQ is a 20-question self-administered scale that evaluates and quantifies the quality of life as related to diabetes - change will be looked at from baseline every 3 months throughout the study.

  weeks 1, 12, 24, 36, 48, 72

Secondary Outcomes (3)

• Adherence - Change from baseline and every 12 weeks up to 72 weeks (18 mo)

  weeks 1, 12, 24, 36, 48, 72

• Psychosocial Measures - Change from baseline and every 24 weeks up to 72 weeks (18 mo)

  weeks 1, 24, 48, 72

• Biological Markers of T1D Complications - Change from baseline and every 24 weeks up to 72 weeks (18 mo)

  weeks 1, 24, 48, 72

Study Arms (4)

Home Telehealth T1D (CoYoT1-HR)

ACTIVE COMPARATOR

Home Telehealth T1D (C2oYoT1-HR), standard of care delivered via Telehealth for high-risk youth

Behavioral: Home Telehealth T1D C2oYoT1-HR

Personalized Adherence Feedback

EXPERIMENTAL

C2oYoT1-HR+Personalized Adherence Intervention

Behavioral: Personalized Adherence Feedback

Personalized Behavioral Health

EXPERIMENTAL

C2oYoT1-HR+Personalized Behavioral Health

Behavioral: Personalized Behavioral Health

C2oYoT1-HR + Adherence + Behavioral

EXPERIMENTAL

C2oYoT1-HR + both Personalized Adherence Feedback + Personalized Behavioral Health (C2oYoT1-HR + Adherence + Behavioral)

Behavioral: Home Telehealth T1D C2oYoT1-HR; Behavioral: Personalized Behavioral Health; Behavioral: Personalized Adherence Feedback

Interventions

Home Telehealth T1D C2oYoT1-HR BEHAVIORAL

1\) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.

Also known as: C2oYoT1-HR

C2oYoT1-HR + Adherence + Behavioral; Home Telehealth T1D (CoYoT1-HR)

Personalized Behavioral Health BEHAVIORAL

1\) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.

Also known as: C2oYoT1-HR + Behavioral Health

C2oYoT1-HR + Adherence + Behavioral; Personalized Behavioral Health

Personalized Adherence Feedback BEHAVIORAL

1\) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.

Also known as: C2oYoT1-HR + Personalized Adherence Intervention

C2oYoT1-HR + Adherence + Behavioral; Personalized Adherence Feedback

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• youth age 10-17 years
• A1C=9-12%
• parent(s) of child with confirmed diagnosis of T1D
• T1D duration \>1 year
• parent and child agree to participate in home telehealth sessions
• ability to use telehealth equipment (i.e., computer, tablet, smartphone with internet connectivity)

You may not qualify if:

• developmental disability or reading disorder that prevents understanding of the intervention materials
• non-English speaking adolescents
• those with severe psychological disorders
• prescribed and taking medications that increase blood glucoses
• not seen in T1D clinic within the past year; pregnant if female; situational concerns (e.g., active custody battle)
• type 2 diabetes

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

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

• Kimberly A Driscoll, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., RCT) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power. The number of arms is listed below as 4 as # of arms is required by the clinicaltrails.gov site; please refer above for a more accurate description of the study design.

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: October 27, 2017
• Study Start: November 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)