CoYoT1 to California (CTC)

Children's Hospital Los Angeles

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: CoYoT1 Care; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03793673

CHLA-18-00488

Details and patient eligibility

About

CoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that consists of three major components: shared decision making (patient and provider agree upon priorities for the medical visit), autonomy and supportive care (provider training in communication strategies such as motivational interviewing), and goal setting and action planning (provider training to coach YA in setting SMART goals, developing action plans, and designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a focus group will be completed to assist in determining which features YA felt were critical to their success from the telehealth intervention, group components, and provider behaviors.

***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all participants who were randomized into in-person appointments will now receive care via Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery of care method during this pandemic. Participants have been notified of this change and given instruction on how to participate in a Telehealth appointment.

Full description

1. Standard Care - Standard (in -person) appointments

   • Usual medical appointments.

   • Opportunity to participate in available community and CHLA based educational and support events.

   • Complete online assessments/questionnaires.

   • Invitation to a 2 hour audio-recorded discussion at the end of the study

     • COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.

2. Standard Care - Telehealth appointments

   • Telehealth - with provider and/or team. Online video appointments every 3 months, upload diabetes data to Tidepool, and do routine blood work at a facility near you

   • Opportunity to participate in available community and CHLA based educational and support events

   • Complete online assessments/questionnaires

   • Invitation to a 2 hour audio-recorded discussion at the end of the study

     • COVID-19 Update: Any community and CHLA based educational and support events will be following COVID-19 guidelines. If in-person routine bloodwork is not feasible, HbA1c kits will be provided to participants.

3. CoYoT1 Care - Standard Appointment

   • In-person - medical appointments with provider and/or team

   • Opportunity to participate in 30-60 minute online peer-led diabetes group discussions

   • Complete online assessments/questionnaires

   • Invitation to a 2 hour audio-recorded discussion at the end of the study

     • COVID-19 Update: Current clinic appointments consist of telehealth appointments only.

4. CoYoT1 Care - Telehealth appointments

   • Telehealth - with provider and/or team. Online video appointment every 3 months, upload your diabetes data to Tidepool, and do routine blood work at a facility near you

   • Opportunity to participate in 30-60 minute online peer-led diabetes group discussions

   • Complete online assessments/questionnaires

   • Invitation to a 2 hour audio-recorded discussion at the end of the study

     • COVID-19 Update: If in-person routine bloodwork is not feasible, HbA1c kits will be provided to participants.

Enrollment: 82 patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient aged 16-25 years of age on their date of recruitment who has had T1D for at least 6 months.
• Receiving or pending care at CHLA
• Has California Children's Services (CCS), self-pay, and/or private insurance (excluding United and Healthnet insurance)
• Does not plan to transfer out of CHLA within the next year

Exclusion criteria

• Any patient with severe behavioral or developmental disabilities
• Severe psychological diagnoses that would make group participation difficult
• Pregnancy
• Non-English speaking patients and families
• Has United or Healthnet private insurance
• Literacy or cognitive issues that preclude the use of the Internet

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

Standard Care: Standard appointments

Other group

Description:

Usual in-person medical appointments. See previous detailed description. COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.

Treatment:

Other: Standard Care

Standard Care: Telehealth appointments

Other group

Description:

Telehealth - with provider and/or team. See previous detailed description.

Treatment:

Other: Standard Care

CoYoT1 Care: Standard Appointment

Other group

Description:

In-person - medical appointments with provider and/or team. See previous detailed description. COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.

Treatment:

Behavioral: CoYoT1 Care

CoYoT1 Care: Telehealth appointments

Other group

Description:

Telehealth - with provider and/or team. See previous detailed description.

Treatment:

Behavioral: CoYoT1 Care