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Completed

NCT Number: NCT01782547

Telehealth Intervention for Youth With T1DM

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth Intervention

Behavioral

Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;

Usual Care

Other

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

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: baseline and 6 months

    Change in hemoglobin A1c over 6 months

Secondary outcomes

  1. % patients meeting ADA HbA1c target

    Time frame: At 6 months

    proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is <7.5%

  2. Diabetes-related adverse events

    Time frame: Up to 6 months

    number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia

  3. Change in Diabetes self-efficacy

    Time frame: Baseline and 6 months

    change over 6 months assessed by questionnaire

  4. Change in Adherence to diabetes self-management

    Time frame: Baseline and 6 months

    change over 6 months assessed by questionnaire

  5. Change in competence with diabetes skills

    Time frame: Baseline and 6 months

    change over 6 months assessed by questionnaire

  6. Change in Health related quality of life

    Time frame: Baseline and 6 months

    change over 6 months assessed by questionnaire

  7. Change in Diabetes Knowledge

    Time frame: Baseline and 6 months

    Change over 6 months assessed by questionnaire

Other outcomes

  1. Direct medical costs

    Time frame: Up to 6 months

    Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention.

  2. Change in diabetes-related family conflict

    Time frame: Baseline and 6 months

    assessed by questionnaire

  3. Change in family responsibility for diabetes tasks

    Time frame: Baseline and 6 months

    assessed by questionnaire

  4. Telehealth intervention satisfaction

    Time frame: At 6 months

    satisfaction, engagement, visit characteristics

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Telehealth Intervention for Youth With Type 1 Diabetes

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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