CoYoT1 to California
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): CoYoT1 Care; Standard Care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescents and Young Adults(AYA)