Telehealth Intervention for Youth With T1DM

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Telehealth Intervention for Youth With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782547
• Other study ID #: P00006175
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: August 12, 2016
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2016
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Telehealth Intervention
Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Change in diabetes-related family conflict	assessed by questionnaire	Baseline and 6 months	No
Other	Change in family responsibility for diabetes tasks	assessed by questionnaire	Baseline and 6 months	No
Other	Telehealth intervention satisfaction	satisfaction, engagement, visit characteristics	At 6 months	No
Primary	Change in Hemoglobin A1c	Change in hemoglobin A1c over 6 months	baseline and 6 months	No
Secondary	% 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	No
Secondary	Diabetes-related adverse events	number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia	Up to 6 months	Yes
Secondary	Change in Diabetes self-efficacy	change over 6 months assessed by questionnaire	Baseline and 6 months	No
Secondary	Change in Adherence to diabetes self-management	change over 6 months assessed by questionnaire	Baseline and 6 months	No
Secondary	Change in competence with diabetes skills	change over 6 months assessed by questionnaire	Baseline and 6 months	No
Secondary	Change in Health related quality of life	change over 6 months assessed by questionnaire	Baseline and 6 months	No
Secondary	Change in Diabetes Knowledge	Change over 6 months assessed by questionnaire	Baseline and 6 months	No