CoYoT1 to California (CTC)

March 13, 2023 updated by: jennifer raymond, Children's Hospital Los Angeles

CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care: Standard appointments

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.

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.

Other: Standard Care: Telehealth appointments
Telehealth - with provider and/or team. See previous detailed description.

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.

Other: CoYoT1 Care: Standard Appointment

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.

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: CoYoT1 Care: Telehealth appointments
Telehealth - with provider and/or team. See previous detailed description.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experience
Time Frame: 12 months
Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating
12 months
Social Determinants of Health Tool
Time Frame: At 0 (baseline)
Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"
At 0 (baseline)
Number of participants with completed appointments in telemedicine cohort
Time Frame: 12 months
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
12 months
Number of participants with completed appointments in telemedicine cohort
Time Frame: 12 months
Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?)
12 months
Number of participants with completed medical appointments in standard care cohort
Time Frame: 12 months
In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment?
12 months
Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire
Time Frame: 12 months
: Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction
12 months
Provider Experience as assessed using the CAHPS survey
Time Frame: 12 months
Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.
12 months
Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire
Time Frame: [Time Frame: For each visit (until the end of study) - 12 months]
Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
[Time Frame: For each visit (until the end of study) - 12 months]
Provider Satisfaction as assessed using the Satisfaction Provider survey
Time Frame: 12 months
Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, "Would you use telehealth again?" Open ended; patient comments about experience.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost to Instituition
Time Frame: 12 months
Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"
12 months
Costs to Patients
Time Frame: 12 months
Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, "driving own vehicle," "riding public transit," "ride with family member or friend." Open ended to assess cost of parking, bus fare.
12 months
Costs to Patients
Time Frame: 12 months
Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, "do you have a personal device to access the internet?." Multiple choice questions about device; "Mobile phone," "Laptop," "Tablet," "Ethernet," "Wi-Fi."
12 months
Costs to Patients
Time Frame: 12 months
Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
12 months
Cost to Instituition
Time Frame: 12 months
Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. "Did you attend your online appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
12 months
Cost to Instituition
Time Frame: 12 months
Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
12 months
Cost to Instituition
Time Frame: 12 months
Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient
12 months
Cost to Instituition
Time Frame: 12 months
Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, "camera and mic," "loading Webex platform."
12 months
Glycemic Control at Baseline
Time Frame: HbA1c for the last 12 months
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
HbA1c for the last 12 months
Glycemic Control Progression
Time Frame: For each visit (until the end of study) - 12 months
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
For each visit (until the end of study) - 12 months
Cost to Payor
Time Frame: 12 months (monthly)
Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, "In the last 3 months, has 911 been called because of your diabetes?" Open-ended questions about rate of health service use, "how many times was 911 called?"
12 months (monthly)
Cost to Payor
Time Frame: 12 months
Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery.
12 months
Cost to Payor
Time Frame: 12 months
Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on "billing process," "data collection process," "camera and mic."
12 months
Cost to Payor as as assessed using the Team Costs- YA
Time Frame: 12 months
Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire.
Time Frame: At 0 (baseline) and 12 months (after visit 4)
Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.
At 0 (baseline) and 12 months (after visit 4)
Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D)
Time Frame: At 0 (baseline) and 12 months (after visit 4)
"Rarely or none of the time (less than 1 day)" is 0, "Some or a little of the time (1-2 days)" is 1, "Occasionally or a moderate amount of time" is 2, "Most or all of the time (5-7 days)" is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
At 0 (baseline) and 12 months (after visit 4)
Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure
Time Frame: At 0 (baseline) and 12 months (after visit 4)
Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.
At 0 (baseline) and 12 months (after visit 4)
Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS)
Time Frame: At 0 (baseline) and 12 months (after visit 4)

Likert scale; "Not a problem" is 1, "A slight problem" is 2, "A moderate problem" is 3, "Somewhat serious problem" is 4, "A Serious Problem" is 5, and "A very serious problem" is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress.

burden, regimen distress, interpersonal distress and physician distress; likert scale

At 0 (baseline) and 12 months (after visit 4)
Assessment of Diabetes-Related Psychosocial Self-Efficacy
Time Frame: At 0 (baseline) and 12 months (after visit 4)
Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
At 0 (baseline) and 12 months (after visit 4)
Self Care - Realted to Diabetes as assessed by Self-Care questionnaire
Time Frame: [At 0 (baseline) and each visit (until the end of study) - 12 months]
Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
[At 0 (baseline) and each visit (until the end of study) - 12 months]
CoYoT1 Care - Tools Questions
Time Frame: [At 12 months or Visit 4]
Record keeping for tools to give to patients in transition to non-study visits (ie: Shared Decision Making tool and Tidepool)
[At 12 months or Visit 4]
Standard Care - Tools Questions
Time Frame: [At 12 months or Visit 4]
Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool)
[At 12 months or Visit 4]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer K Raymond, MD, MCR, Children's Hospital Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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