Type 1 Diabetes MellitusCTCNCT03793673
CoYoT1 to California
A study testing CoYoT1 Care in people with Type 1 Diabetes Mellitus, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CoYoT1 Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CoYoT1 Care, Standard Care
- Keywords
- Adolescents and Young Adults(AYA)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoYoT1 CareBehavioural
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.
Standard CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care: Standard appointments | Other | 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. Receives: Other: Standard Care |
| Standard Care: Telehealth appointments | Other | Telehealth - with provider and/or team. See previous detailed description. Receives: Other: Standard Care |
| CoYoT1 Care: Standard Appointment | Other | 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. Receives: Behavioral: CoYoT1 Care |
| CoYoT1 Care: Telehealth appointments | Other | Telehealth - with provider and/or team. See previous detailed description. Receives: Behavioral: CoYoT1 Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with completed appointments in telemedicine cohort
Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Measured: 12 months
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?)
Measured: 12 months
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?
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
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
Measured: [Time Frame: For each visit (until the end of study) - 12 months]
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.
Measured: 12 months
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
Measured: 12 months
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?"
Measured: At 0 (baseline)
Secondary outcomes (14)
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.
Measured: 12 months
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."
Measured: 12 months
Costs to Patients
Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Measured: 12 months
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?"
Measured: 12 months
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?"
Measured: 12 months
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?"
Measured: 12 months
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
Measured: 12 months
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."
Measured: 12 months
Glycemic Control at Baseline
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measured: HbA1c for the last 12 months
Glycemic Control Progression
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measured: For each visit (until the end of study) - 12 months
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?"
Measured: 12 months (monthly)
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.
Measured: 12 months
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."
Measured: 12 months
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".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start20 Jan 2019
- Primary completion28 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Rutgers University
- Responsible party
- Principal investigator, jennifer raymond, Children's Hospital Los Angeles
- Investigators
- Jennifer K Raymond, MD, MCR, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793673
- Sponsor's protocol ID
- CHLA-18-00488
- Acronym
- CTC
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guljas R, Ahmed A, Chang K, Whitlock A. Impact of telemedicine in managing type 1 diabetes among school-age children and adolescents: an integrative review. J Pediatr Nurs. 2014 May-Jun;29(3):198-204. doi: 10.1016/j.pedn.2013.10.013. Epub 2013 Oct 31.
PubMed 24269308Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
PubMed 23340893Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
PubMed 25998289Park MJ, Scott JT, Adams SH, Brindis CD, Irwin CE Jr. Adolescent and young adult health in the United States in the past decade: little improvement and young adults remain worse off than adolescents. J Adolesc Health. 2014 Jul;55(1):3-16. doi: 10.1016/j.jadohealth.2014.04.003. Epub 2014 May 10.
PubMed 24815958Monaghan M, Helgeson V, Wiebe D. Type 1 diabetes in young adulthood. Curr Diabetes Rev. 2015;11(4):239-50. doi: 10.2174/1573399811666150421114957.
PubMed 25901502American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
PubMed 23468086Li R, Barker LE, Shrestha S, Zhang P, Duru OK, Pearson-Clarke T, Gregg EW. Changes over time in high out-of-pocket health care burden in U.S. adults with diabetes, 2001-2011. Diabetes Care. 2014 Jun;37(6):1629-35. doi: 10.2337/dc13-1997. Epub 2014 Mar 25.
PubMed 24667459Naranjo D, Schwartz DD, Delamater AM. Diabetes in ethnically diverse youth: disparate burden and intervention approaches. Curr Diabetes Rev. 2015;11(4):251-60. doi: 10.2174/1573399811666150421115846.
PubMed 25901501Valenzuela JM, Seid M, Waitzfelder B, Anderson AM, Beavers DP, Dabelea DM, Dolan LM, Imperatore G, Marcovina S, Reynolds K, Yi-Frazier J, Mayer-Davis EJ; SEARCH for Diabetes in Youth Study Group. Prevalence of and disparities in barriers to care experienced by youth with type 1 diabetes. J Pediatr. 2014 Jun;164(6):1369-75.e1. doi: 10.1016/j.jpeds.2014.01.035. Epub 2014 Feb 25.
PubMed 24582008Lado JJ, Lipman TH. Racial and Ethnic Disparities in the Incidence, Treatment, and Outcomes of Youth with Type 1 Diabetes. Endocrinol Metab Clin North Am. 2016 Jun;45(2):453-61. doi: 10.1016/j.ecl.2016.01.002. Epub 2016 Apr 7.
PubMed 27241975Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
PubMed 17881626Zuijdwijk CS, Cuerden M, Mahmud FH. Social determinants of health on glycemic control in pediatric type 1 diabetes. J Pediatr. 2013 Apr;162(4):730-5. doi: 10.1016/j.jpeds.2012.12.010. Epub 2013 Jan 26.
PubMed 23360562Hill KE, Gleadle JM, Pulvirenti M, McNaughton DA. The social determinants of health for people with type 1 diabetes that progress to end-stage renal disease. Health Expect. 2015 Dec;18(6):2513-21. doi: 10.1111/hex.12220. Epub 2014 Jun 17.
PubMed 24938493Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available.
PubMed 22025785Introduction. Diabetes Care. 2017 Jan;40(Suppl 1):S1-S2. doi: 10.2337/dc17-S001. No abstract available.
PubMed 27979885
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
- ClinicalTrials.gov ID
- NCT03793673
- Acronym / sponsor ID
- CTC / CHLA-18-00488
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Adolescents and Young Adults(AYA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California, Rutgers University
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Care: Standard appointments | Other | Other: Standard CareUsual 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. |
| Standard Care: Telehealth appointments | Other | Other: Standard CareTelehealth - with provider and/or team. See previous detailed description. |
| CoYoT1 Care: Standard Appointment | Other | Behavioral: CoYoT1 CareIn-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. |
| CoYoT1 Care: Telehealth appointments | Other | Behavioral: CoYoT1 CareTelehealth - with provider and/or team. See previous detailed description. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoYoT1 CareSelected 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. | Behavioural | CoYoT1 Care: Standard Appointment, CoYoT1 Care: Telehealth appointments |
| Standard CareProviders 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: Standard appointments, Standard Care: Telehealth appointments |
Primary outcome
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
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?)
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?
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
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.
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
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.
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
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?"
14 secondary outcomes
Costs to Patients
Time frame: 12 months
Costs to Patients
Time frame: 12 months
Costs to Patients
Time frame: 12 months
Cost to Instituition
Time frame: 12 months
Cost to Instituition
Time frame: 12 months
Cost to Instituition
Time frame: 12 months
Cost to Instituition
Time frame: 12 months
Cost to Instituition
Time frame: 12 months
Glycemic Control at Baseline
Time frame: HbA1c for the last 12 months
Glycemic Control Progression
Time frame: For each visit (until the end of study) - 12 months
Cost to Payor
Time frame: 12 months (monthly)
Cost to Payor
Time frame: 12 months
Cost to Payor
Time frame: 12 months
Cost to Payor as as assessed using the Team Costs- YA
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 24269308Guljas R, Ahmed A, Chang K, Whitlock A. Impact of telemedicine in managing type 1 diabetes among school-age children and adolescents: an integrative review. J Pediatr Nurs. 2014 May-Jun;29(3):198-204. doi: 10.1016/j.pedn.2013.10.013. Epub 2013 Oct 31.
- Background: PubMed 23340893Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
- Background: PubMed 25998289Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
- Background: PubMed 24815958Park MJ, Scott JT, Adams SH, Brindis CD, Irwin CE Jr. Adolescent and young adult health in the United States in the past decade: little improvement and young adults remain worse off than adolescents. J Adolesc Health. 2014 Jul;55(1):3-16. doi: 10.1016/j.jadohealth.2014.04.003. Epub 2014 May 10.
- Background: PubMed 25901502Monaghan M, Helgeson V, Wiebe D. Type 1 diabetes in young adulthood. Curr Diabetes Rev. 2015;11(4):239-50. doi: 10.2174/1573399811666150421114957.
- Background: PubMed 23468086American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
- Background: PubMed 24667459Li R, Barker LE, Shrestha S, Zhang P, Duru OK, Pearson-Clarke T, Gregg EW. Changes over time in high out-of-pocket health care burden in U.S. adults with diabetes, 2001-2011. Diabetes Care. 2014 Jun;37(6):1629-35. doi: 10.2337/dc13-1997. Epub 2014 Mar 25.
- Background: PubMed 25901501Naranjo D, Schwartz DD, Delamater AM. Diabetes in ethnically diverse youth: disparate burden and intervention approaches. Curr Diabetes Rev. 2015;11(4):251-60. doi: 10.2174/1573399811666150421115846.
- Background: PubMed 24582008Valenzuela JM, Seid M, Waitzfelder B, Anderson AM, Beavers DP, Dabelea DM, Dolan LM, Imperatore G, Marcovina S, Reynolds K, Yi-Frazier J, Mayer-Davis EJ; SEARCH for Diabetes in Youth Study Group. Prevalence of and disparities in barriers to care experienced by youth with type 1 diabetes. J Pediatr. 2014 Jun;164(6):1369-75.e1. doi: 10.1016/j.jpeds.2014.01.035. Epub 2014 Feb 25.
- Background: PubMed 27241975Lado JJ, Lipman TH. Racial and Ethnic Disparities in the Incidence, Treatment, and Outcomes of Youth with Type 1 Diabetes. Endocrinol Metab Clin North Am. 2016 Jun;45(2):453-61. doi: 10.1016/j.ecl.2016.01.002. Epub 2016 Apr 7.
- Background: PubMed 17881626Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
- Background: PubMed 23360562Zuijdwijk CS, Cuerden M, Mahmud FH. Social determinants of health on glycemic control in pediatric type 1 diabetes. J Pediatr. 2013 Apr;162(4):730-5. doi: 10.1016/j.jpeds.2012.12.010. Epub 2013 Jan 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer K Raymond, MD, MCR principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoYoT1 Care in people with Type 1 Diabetes Mellitus, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with completed appointments in telemedicine cohort (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793673, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.