NCT03793673

CoYoT1 to California

CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 16 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	CoYoT1 Care	Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.
OTHER	Standard Care	Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care. NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.

Timeline

• Start date: 2019-01-20
• Primary completion: 2022-07-28
• Completion: 2022-12-31
• First posted: 2019-01-04
• Last updated: 2023-03-15

Locations

1 site across 1 country: United States