Telehealth Intervention for Youth With T1DM

Telehealth Intervention for Youth With Type 1 Diabetes

Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. This is a randomized, controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm and usual care control arm matched for frequency of contacts. There will be 110 subjects with T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention will be implemented by a diabetes nurse educator and social worker, who will each have monthly contact with the adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth interventions have been utilized successfully in both adults and youth with diabetes. They facilitate frequent contact with the care team allowing barriers to adherence to be addressed, education to be reinforced, care plans to be updated, and diabetes-specific family support to be provided.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Telehealth Intervention; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 13 to 17 years
• Type 1 diabetes for ≥1 year
• HbA1c>8%
• Able to speak and read English (Child)
• Able to speak and read English (Parent)
• Parent agrees to participate
• Parent and child each have email addresses

Exclusion Criteria:

• Plan to transition diabetes care to a center other than Boston Children's Hospital
• No visit to Boston Children's Hospital Diabetes Program in year prior to recruitment
• Current participation in another diabetes-related study with an intervention
• Living with or related to another study participant
• Significant psychopathology or medical illness that would limit the subject's ability to provide assent and/or participate in the study procedures as determined by the PI.
• No internet access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth Intervention; Telehealth intervention - 6 months	Behavioral: Telehealth Intervention; Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;
Active Comparator: Usual care; Usual care control with comparable frequency of contact	Other: Usual Care; Standard diabetes care- typically a visit with a diabetes health care provider every 3 months and referrals to a dietitian or mental health specialist as deemed appropriate; Study participation reminder cards twice per month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	Change in hemoglobin A1c over 6 months	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% patients meeting ADA HbA1c target	proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is <7.5%	At 6 months
Diabetes-related adverse events	number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia	Up to 6 months
Change in Diabetes self-efficacy	change over 6 months assessed by questionnaire	Baseline and 6 months
Change in Adherence to diabetes self-management	change over 6 months assessed by questionnaire	Baseline and 6 months
Change in competence with diabetes skills	change over 6 months assessed by questionnaire	Baseline and 6 months
Change in Health related quality of life	change over 6 months assessed by questionnaire	Baseline and 6 months
Change in Diabetes Knowledge	Change over 6 months assessed by questionnaire	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct medical costs	Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention.	Up to 6 months
Change in diabetes-related family conflict	assessed by questionnaire	Baseline and 6 months
Change in family responsibility for diabetes tasks	assessed by questionnaire	Baseline and 6 months
Telehealth intervention satisfaction	satisfaction, engagement, visit characteristics	At 6 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Erinn T Rhodes, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 12, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: adolescents; diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: P00006175