Clinical trial NCT03793673: CoYoT1 to California
Official title: CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Adolescents and Young Adults(AYA)
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Rutgers University
First posted: 2019-01-04
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with completed appointments in telemedicine cohort
timeFrame: 12 months
measure: Number of participants with completed appointments in telemedicine cohort
timeFrame: 12 months
measure: Number of participants with completed medical appointments in standard care cohort
timeFrame: 12 months
measure: Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire
timeFrame: 12 months
measure: Provider Experience as assessed using the CAHPS survey
timeFrame: 12 months
measure: Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire
timeFrame: [Time Frame: For each visit (until the end of study) - 12 months]
measure: Provider Satisfaction as assessed using the Satisfaction Provider survey
timeFrame: 12 months
measure: Patient Experience
timeFrame: 12 months
measure: Social Determinants of Health Tool
timeFrame: At 0 (baseline)
Secondary outcomes:
measure: Costs to Patients
timeFrame: 12 months
measure: Costs to Patients
timeFrame: 12 months
measure: Costs to Patients
timeFrame: 12 months
measure: Cost to Instituition
timeFrame: 12 months
measure: Cost to Instituition
timeFrame: 12 months
measure: Cost to Instituition
timeFrame: 12 months
measure: Cost to Instituition
timeFrame: 12 months
measure: Cost to Instituition
timeFrame: 12 months
measure: Glycemic Control at Baseline
timeFrame: HbA1c for the last 12 months
measure: Glycemic Control Progression
timeFrame: For each visit (until the end of study) - 12 months
measure: Cost to Payor
timeFrame: 12 months (monthly)
measure: Cost to Payor
timeFrame: 12 months
measure: Cost to Payor
timeFrame: 12 months
measure: Cost to Payor as as assessed using the Team Costs- YA
timeFrame: 12 months
Other outcomes:
measure: Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire.
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D)
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS)
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Assessment of Diabetes-Related Psychosocial Self-Efficacy
timeFrame: At 0 (baseline) and 12 months (after visit 4)
measure: Self Care - Realted to Diabetes as assessed by Self-Care questionnaire
timeFrame: [At 0 (baseline) and each visit (until the end of study) - 12 months]
measure: CoYoT1 Care - Tools Questions
timeFrame: [At 12 months or Visit 4]
measure: Standard Care - Tools Questions
timeFrame: [At 12 months or Visit 4]
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jennifer K Raymond, MD, MCR
role: PRINCIPAL_INVESTIGATOR
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