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CoYoT1 to California (CTC)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CoYoT1 Care
Standard Care
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Adolescents and Young Adults(AYA)

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Standard Care: Standard appointments

Standard Care: Telehealth appointments

CoYoT1 Care: Standard Appointment

CoYoT1 Care: Telehealth appointments

Arm 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.

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

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

Outcomes

Primary Outcome Measures

Number of participants with completed appointments in telemedicine cohort
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Number of participants with completed appointments in telemedicine cohort
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?)
Number of participants with completed medical appointments in standard care cohort
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?
Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire
: 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
Provider Experience as assessed using the CAHPS survey
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.
Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire
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
Provider Satisfaction as assessed using the Satisfaction Provider survey
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.
Patient Experience
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
Social Determinants of Health Tool
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?"

Secondary Outcome Measures

Costs to Patients
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.
Costs to Patients
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."
Costs to Patients
Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Cost to Instituition
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?"
Cost to Instituition
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?"
Cost to Instituition
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?"
Cost to Instituition
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
Cost to Instituition
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."
Glycemic Control at Baseline
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Glycemic Control Progression
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Cost to Payor
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?"
Cost to Payor
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.
Cost to Payor
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."
Cost to Payor as as assessed using the Team Costs- YA
Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".

Full Information

First Posted
November 23, 2018
Last Updated
March 13, 2023
Sponsor
Children's Hospital Los Angeles
Collaborators
University of Southern California, Rutgers University
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1. Study Identification

Unique Protocol Identification Number
NCT03793673
Brief Title
CoYoT1 to California
Acronym
CTC
Official Title
CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
University of Southern California, Rutgers University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Adolescents and Young Adults(AYA)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care: Standard appointments
Arm Type
Other
Arm 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.
Arm Title
Standard Care: Telehealth appointments
Arm Type
Other
Arm Description
Telehealth - with provider and/or team. See previous detailed description.
Arm Title
CoYoT1 Care: Standard Appointment
Arm Type
Other
Arm 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.
Arm Title
CoYoT1 Care: Telehealth appointments
Arm Type
Other
Arm Description
Telehealth - with provider and/or team. See previous detailed description.
Intervention Type
Behavioral
Intervention Name(s)
CoYoT1 Care
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention 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.
Primary Outcome Measure Information:
Title
Number of participants with completed appointments in telemedicine cohort
Description
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Time Frame
12 months
Title
Number of participants with completed appointments in telemedicine cohort
Description
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?)
Time Frame
12 months
Title
Number of participants with completed medical appointments in standard care cohort
Description
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?
Time Frame
12 months
Title
Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire
Description
: 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
Time Frame
12 months
Title
Provider Experience as assessed using the CAHPS survey
Description
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.
Time Frame
12 months
Title
Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire
Description
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
[Time Frame: For each visit (until the end of study) - 12 months]
Title
Provider Satisfaction as assessed using the Satisfaction Provider survey
Description
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.
Time Frame
12 months
Title
Patient Experience
Description
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
Time Frame
12 months
Title
Social Determinants of Health Tool
Description
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?"
Time Frame
At 0 (baseline)
Secondary Outcome Measure Information:
Title
Costs to Patients
Description
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.
Time Frame
12 months
Title
Costs to Patients
Description
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."
Time Frame
12 months
Title
Costs to Patients
Description
Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Time Frame
12 months
Title
Cost to Instituition
Description
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?"
Time Frame
12 months
Title
Cost to Instituition
Description
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?"
Time Frame
12 months
Title
Cost to Instituition
Description
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?"
Time Frame
12 months
Title
Cost to Instituition
Description
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
Time Frame
12 months
Title
Cost to Instituition
Description
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."
Time Frame
12 months
Title
Glycemic Control at Baseline
Description
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Time Frame
HbA1c for the last 12 months
Title
Glycemic Control Progression
Description
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Time Frame
For each visit (until the end of study) - 12 months
Title
Cost to Payor
Description
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?"
Time Frame
12 months (monthly)
Title
Cost to Payor
Description
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.
Time Frame
12 months
Title
Cost to Payor
Description
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."
Time Frame
12 months
Title
Cost to Payor as as assessed using the Team Costs- YA
Description
Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire.
Description
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.
Time Frame
At 0 (baseline) and 12 months (after visit 4)
Title
Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D)
Description
"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.
Time Frame
At 0 (baseline) and 12 months (after visit 4)
Title
Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure
Description
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.
Time Frame
At 0 (baseline) and 12 months (after visit 4)
Title
Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS)
Description
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
Time Frame
At 0 (baseline) and 12 months (after visit 4)
Title
Assessment of Diabetes-Related Psychosocial Self-Efficacy
Description
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
Time Frame
At 0 (baseline) and 12 months (after visit 4)
Title
Self Care - Realted to Diabetes as assessed by Self-Care questionnaire
Description
Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
Time Frame
[At 0 (baseline) and each visit (until the end of study) - 12 months]
Title
CoYoT1 Care - Tools Questions
Description
Record keeping for tools to give to patients in transition to non-study visits (ie: Shared Decision Making tool and Tidepool)
Time Frame
[At 12 months or Visit 4]
Title
Standard Care - Tools Questions
Description
Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool)
Time Frame
[At 12 months or Visit 4]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer K Raymond, MD, MCR
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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