Type 1 DiabetesNCT04190368
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
A study testing Team Clinic Care in people with Type 1 Diabetes, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Team Clinic Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 30 Nov 2024
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of type 1 diabetes > 6 month duration
- Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
- Not currently participating in other group interventions
- English speaking
- Exclusions
- Severe behavioral or developmental disabilities in parent or child
Show all 9Show fewer
- Severe psychological diagnoses in parent or child that would make group participation difficult
- Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
- Non-English speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Middle School and High School Adolescents and Young Adults With Type 1 Diabetes
Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.
Groups:
Read more
- Standard Care - No Group
- Standard Care - Virtual Team Clinic Group
- Team Clinic Care - No Group
- Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)
- Patients and parents will attend their own online session
Read the detailed description
Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.
- Conditions
- Type 1 Diabetes
- Being tested
- Team Clinic Care, Standard Care
- Keywords
- Adolescents, Young Adults, Group Medical Visits
- 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.
Team Clinic CareOther
Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient.
Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components:
(1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment
Standard CareOther
Participants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods.
| Study group | Role | What they receive |
|---|---|---|
| Team Clinic Care: No VTC Groups | Other | Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed
• Providers will utilize a patient centered care approach to conducting appointments Receives: Other: Team Clinic Care |
| Team Clinic: Virtual Team Clinic Group | Other | Participants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care.
o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed Receives: Other: Team Clinic Care |
| Standard Care: No VTC Groups | Other | Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). Receives: Other: Standard Care |
| Standard Care: Virtual Team Clinic | Other | Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services).
o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C at Baseline
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measured: baseline to 12 months
Hemoglobin A1C Progression
HbA1c % At-Home Kit
Measured: At baseline (0), 3 months, 6 months, 9 months, 12 months
Number of Team Clinic Care cohort participants attending appointments
Attendance will be recorded for each Team Clinic visit
Measured: 12 months
Number of Virtual Team Clinic Care cohort participants completing appointments
Attendance will be recorded for each Virtual Team Clinic Visit
Measured: 12 months
Number of Team Clinic Care cohort participants completing appointments
Electronic Medical Record (EMR) Abstraction
Measured: 12 months
Patient and Provider/Clinic Staff 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
Patient and Provider/Staff Satisfaction
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 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)
Number of Standard Clinic cohort participants completing appointments
Attendance will be recorded for each standard care visit
Measured: 12 months
Number of Standard Care cohort participants completing appointments
Electronic Medical Record (EMR) Abstraction
Measured: 12 months
Secondary outcomes (22)
Number of Team Clinic Care cohort participants with diabetic ketoacidosis
Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR
Measured: 12 months
Number of Standard Care cohort participants with diabetic ketoacidosis
Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR
Measured: 12 months
Number of Team Clinic cohort participants with severe hypoglycemia
Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR
Measured: 12 months
Number of Standard Care cohort participants with severe hypoglycemia
Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR
Measured: 12 months
Diabetes Family Conflict Scale
Diabetes Family Conflict as assessed using the Diabetes Family Conflict Scale (DFCS) for parents and the DFCS for children. Each scale is a 20 item questionnaire using a Likert Scale (1 = Almost Never, 2 = Sometimes, 3 = Almost Always). Parent and Child questionnaires are combined with a possible score range from 40 to 120 with higher scores indicating more conflict.
Measured: At 0 (baseline) and 12 months (after visit 4)
Problem Areas in Diabetes in Caregivers
Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Caregivers (PAID-T). This instrument was designed to assess emotional distress related to caring for a teen with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.
Measured: At 0 (baseline) and 12 months (after visit 4)
Problem Areas in Diabetes in Teens
Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Teens (PAID-T). This instrument was designed to assess emotional distress in teens with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.
Measured: At 0 (baseline) and 12 months (after visit 4)
Patient - Practitioner Orientation Scale
Patient - Practitioner Orientation Scale consists of 18 items and 2 subscales. It assesses provider beliefs on patient centeredness. 6-point Likert scale: "Strongly disagree," "Moderately Disagree," "Slightly Disagree," "Slightly Agree," "Moderately Agree," and "Strongly Agree." PPOs score is computed by taking the mean of the 18 items with a minimum score being "1" and maximum being "6." Higher scores present more patient-centered attitudes.
Measured: At 0 (baseline) and 12 months (after visit 4)
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 Institution - Standard care
Cost to Institution as assessed using the In Person questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person, standard care appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
Measured: 12 months
Cost to Institution - Team Clinic
Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to in person, Team Clinic care appointment. "Did you attend your in person appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
Measured: 12 months
Cost to Institution - Clinic Costs
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 Institution - Team Costs
Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained (e.g. role), "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for Team Clinic appointment; training on, "roles of the attendees," in Team Clinic. Issues regarding the study and study toolkit.
Measured: 12 months
Cost to Institution
Cost to Institution as assessed using the Feasibility and Usability of Toolkit questionnaire. Multiple choice questions used to identify the training session, role, provider, usability of toolkit, and training time. The questionnaire also includes a 6-point Likert scale: "Strongly disagree," "Somewhat Disagree," "Neutral," "Slightly Agree," "Somewhat Agree," and "Strongly Agree."
Measured: 12 months
Clinical Efficiency
Assessed using the Clinical Efficiency questionnaire which captures the number of patients seen during a given time period), team members seen, and time patients spent with team members.
Measured: 12 months
Diabetes Strengths and Resilience Measure for Children
DSTAR-Child assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.
Measured: At 0 (baseline) and 12 months (after visit 4)
Diabetes Strengths and Resilience Measure for Teens
DSTAR-Teen assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.
Measured: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Peds Peer Relationships
Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Peer Relationships. Evaluates and monitors social health. Likert scale used to assess quality of relationships with friends and acquaintances. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Measured: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Peds Family Relationships
Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Family Relationships. Evaluates and monitors social health. Likert scale used to assess the subjective (affective, emotional, cognitive) experience of being involved with one's family, feeling like an important person in the family, of feeling accepted and cared for, and feeling that family members, especially parents, can be trusted and depended on for help and understanding. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Measured: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Emotional Support
Patient-Reported Outcomes Measurement Information System (PROMIS )- Emotional Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing perceived feelings of being cared for and valued as a person; having confidant relationships. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Measured: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Instrumental Support
Patient-Reported Outcomes Measurement Information System (PROMIS )- Instrumental Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of assistance with material, cognitive or task performance. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Measured: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Informational Support
Patient-Reported Outcomes Measurement Information System (PROMIS )- Informational Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of helpful information or advice.. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)
Measured: At 0 (baseline) and 12 months (after visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start7 Sep 2021
- Primary completion31 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Cedars-Sinai Medical Center
- 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
- NCT04190368
- Sponsor's protocol ID
- CHLA-19-00062
- Status last verified
- Apr 2025
- First submitted
- 22 Jul 2019
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Development, execution, and data collection for this study is completed with a Principle Investigator at Children's Hospital Los Angeles. With documented permission of the IRB, a PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested Investigators will complete a request form stating the aims of their analyses, analytic plan, available resources for completing a project, timeline, and goals (i.e. manuscripts or grant applications). The PIs and their research team will review requests to determine whether the analyses constitute an innovative exploration of the data, whether the team has resources to complete the request, and whether data will be adequately protected and managed. If issues arise, the PIs and research team will negotiate a fair resolution with interested investigators and NIH staff.
Publications
Miller 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 25998289Reiss J, Gibson R. Health care transition: destinations unknown. Pediatrics. 2002 Dec;110(6 Pt 2):1307-14.
PubMed 12456950Peters 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 22025785Rosen DS, Blum RW, Britto M, Sawyer SM, Siegel DM; Society for Adolescent Medicine. Transition to adult health care for adolescents and young adults with chronic conditions: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2003 Oct;33(4):309-11. doi: 10.1016/s1054-139x(03)00208-8. No abstract available.
PubMed 14519573Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052.
PubMed 12663572Sanchez I. Implementation of a diabetes self-management education program in primary care for adults using shared medical appointments. Diabetes Educ. 2011 May-Jun;37(3):381-91. doi: 10.1177/0145721711401667. Epub 2011 Mar 31.
PubMed 21454887Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. doi: 10.1016/s0091-2182(97)00117-1.
PubMed 9489291Noffsinger E. Enhance satisfaction with drop-in group visits. . Hippocrates. 2001;15(2):30-36.
Noffsinger EB. Running Group Visits in Your Practice. New York, NY: Springer Science+Business Media; 2009.
Floyd BD, Block JM, Buckingham BB, Ly T, Foster N, Wright R, Mueller CL, Hood KK, Shah AC. Stabilization of glycemic control and improved quality of life using a shared medical appointment model in adolescents with type 1 diabetes in suboptimal control. Pediatr Diabetes. 2017 May;18(3):204-212. doi: 10.1111/pedi.12373. Epub 2016 Feb 26.
PubMed 26919322Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.
PubMed 25717281Hood KK, Butler DA, Anderson BJ, Laffel LM. Updated and revised Diabetes Family Conflict Scale. Diabetes Care. 2007 Jul;30(7):1764-9. doi: 10.2337/dc06-2358. Epub 2007 Mar 19.
PubMed 17372149Evans M, Davis, L, & Weissberg-Benchell, J. Psychometric properties of the child and parent problem areas in diabetes measures. Paper presented at: Poster presented at the 76th Annual Scientific Sessions of the American Diabetes AssociationJune, 2016; New Orleans, Louisiana.
Weissberg-Benchell J, Antisdel-Lomaglio J. Diabetes-specific emotional distress among adolescents: feasibility, reliability, and validity of the problem areas in diabetes-teen version. Pediatr Diabetes. 2011 Jun;12(4 Pt 1):341-4. doi: 10.1111/j.1399-5448.2010.00720.x. Epub 2011 Mar 28.
PubMed 21443583McClain MR, Klingensmith GJ, Anderson B, Berget C, Cain C, Shea J, Campbell K, Pyle L, Raymond JK. Team Clinic: Group Approach to Care of Early Adolescents With Type 1 Diabetes. Diabetes Spectr. 2018 Aug;31(3):273-278. doi: 10.2337/ds17-0063. No abstract available.
PubMed 30140144
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Middle School and High School Adolescents and Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04190368
- Acronym / sponsor ID
- CHLA-19-00062
- Conditions
- Type 1 Diabetes
- Keywords
- Adolescents, Young Adults, Group Medical Visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California, Cedars-Sinai Medical Center
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 9 Dec 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.
Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.
Groups:
- Standard Care - No Group
- Standard Care - Virtual Team Clinic Group
- Team Clinic Care - No Group
- Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)
- Patients and parents will attend their own online session
Detailed description
Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Team Clinic Care: No VTC Groups | Other | Other: Team Clinic CareParticipants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed • Providers will utilize a patient centered care approach to conducting appointments |
| Team Clinic: Virtual Team Clinic Group | Other | Other: Team Clinic CareParticipants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed |
| Standard Care: No VTC Groups | Other | Other: Standard CareAppointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). |
| Standard Care: Virtual Team Clinic | Other | Other: Standard CareAppointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Diagnosis of type 1 diabetes > 6 month duration
- Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
- Not currently participating in other group interventions
- English speaking
- Exclusions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Team Clinic CareParticipants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient. Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components: (1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment | Other | Team Clinic Care: No VTC Groups, Team Clinic: Virtual Team Clinic Group |
| Standard CareParticipants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods. | Other | Standard Care: No VTC Groups, Standard Care: Virtual Team Clinic |
Primary outcome
Hemoglobin A1C at Baseline
Time frame: baseline to 12 months
Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Hemoglobin A1C Progression
Time frame: At baseline (0), 3 months, 6 months, 9 months, 12 months
HbA1c % At-Home Kit
Number of Team Clinic Care cohort participants attending appointments
Time frame: 12 months
Attendance will be recorded for each Team Clinic visit
Number of Virtual Team Clinic Care cohort participants completing appointments
Time frame: 12 months
Attendance will be recorded for each Virtual Team Clinic Visit
Number of Team Clinic Care cohort participants completing appointments
Time frame: 12 months
Electronic Medical Record (EMR) Abstraction
Patient and Provider/Clinic Staff 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
Patient and Provider/Staff Satisfaction
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 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?"
Number of Standard Clinic cohort participants completing appointments
Time frame: 12 months
Attendance will be recorded for each standard care visit
Number of Standard Care cohort participants completing appointments
Time frame: 12 months
Electronic Medical Record (EMR) Abstraction
22 secondary outcomes
Number of Team Clinic Care cohort participants with diabetic ketoacidosis
Time frame: 12 months
Number of Standard Care cohort participants with diabetic ketoacidosis
Time frame: 12 months
Number of Team Clinic cohort participants with severe hypoglycemia
Time frame: 12 months
Number of Standard Care cohort participants with severe hypoglycemia
Time frame: 12 months
Diabetes Family Conflict Scale
Time frame: At 0 (baseline) and 12 months (after visit 4)
Problem Areas in Diabetes in Caregivers
Time frame: At 0 (baseline) and 12 months (after visit 4)
Problem Areas in Diabetes in Teens
Time frame: At 0 (baseline) and 12 months (after visit 4)
Patient - Practitioner Orientation Scale
Time frame: At 0 (baseline) and 12 months (after visit 4)
Cost to Instituition
Time frame: 12 months
Cost to Institution - Standard care
Time frame: 12 months
Cost to Institution - Team Clinic
Time frame: 12 months
Cost to Institution - Clinic Costs
Time frame: 12 months
Cost to Institution - Team Costs
Time frame: 12 months
Cost to Institution
Time frame: 12 months
Clinical Efficiency
Time frame: 12 months
Diabetes Strengths and Resilience Measure for Children
Time frame: At 0 (baseline) and 12 months (after visit 4)
Diabetes Strengths and Resilience Measure for Teens
Time frame: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Peds Peer Relationships
Time frame: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Peds Family Relationships
Time frame: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Emotional Support
Time frame: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Instrumental Support
Time frame: At 0 (baseline) and 12 months (after visit 4)
PROMIS - Informational Support
Time frame: At 0 (baseline) and 12 months (after visit 4)
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 4 Apr 2025.
- 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 12456950Reiss J, Gibson R. Health care transition: destinations unknown. Pediatrics. 2002 Dec;110(6 Pt 2):1307-14.
- Background: PubMed 22025785Peters 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.
- Background: PubMed 14519573Rosen DS, Blum RW, Britto M, Sawyer SM, Siegel DM; Society for Adolescent Medicine. Transition to adult health care for adolescents and young adults with chronic conditions: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2003 Oct;33(4):309-11. doi: 10.1016/s1054-139x(03)00208-8. No abstract available.
- Background: PubMed 12663572Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052.
- Background: PubMed 21454887Sanchez I. Implementation of a diabetes self-management education program in primary care for adults using shared medical appointments. Diabetes Educ. 2011 May-Jun;37(3):381-91. doi: 10.1177/0145721711401667. Epub 2011 Mar 31.
- Background: PubMed 9489291Rising SS. Centering pregnancy. An interdisciplinary model of empowerment. J Nurse Midwifery. 1998 Jan-Feb;43(1):46-54. doi: 10.1016/s0091-2182(97)00117-1.
- BackgroundNoffsinger E. Enhance satisfaction with drop-in group visits. . Hippocrates. 2001;15(2):30-36.
- BackgroundNoffsinger EB. Running Group Visits in Your Practice. New York, NY: Springer Science+Business Media; 2009.
- Background: PubMed 26919322Floyd BD, Block JM, Buckingham BB, Ly T, Foster N, Wright R, Mueller CL, Hood KK, Shah AC. Stabilization of glycemic control and improved quality of life using a shared medical appointment model in adolescents with type 1 diabetes in suboptimal control. Pediatr Diabetes. 2017 May;18(3):204-212. doi: 10.1111/pedi.12373. Epub 2016 Feb 26.
- Background: PubMed 25717281Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.
- Background: PubMed 17372149Hood KK, Butler DA, Anderson BJ, Laffel LM. Updated and revised Diabetes Family Conflict Scale. Diabetes Care. 2007 Jul;30(7):1764-9. doi: 10.2337/dc06-2358. Epub 2007 Mar 19.
- Individual participant dataSharing planned: Yes. Development, execution, and data collection for this study is completed with a Principle Investigator at Children's Hospital Los Angeles. With documented permission of the IRB, a PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested Investigators will complete a request form stating the aims of their analyses, analytic plan, available resources for completing a project, timeline, and goals (i.e. manuscripts or grant applications). The PIs and their research team will review requests to determine whether the analyses constitute an innovative exploration of the data, whether the team has resources to complete the request, and whether data will be adequately protected and managed. If issues arise, the PIs and research team will negotiate a fair resolution with interested investigators and NIH staff.
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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 Team Clinic Care in people with Type 1 Diabetes, 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 9 inclusion and 0 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 4 Apr 2025. 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?
Hemoglobin A1C at Baseline (time frame: baseline to 12 months). The study lists 11 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 NCT04190368, which also lists 33 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 4 Apr 2025.