Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190368
Recruitment Status : Not yet recruiting
First Posted : December 9, 2019
Last Update Posted : March 1, 2021
Sponsor:
Collaborators:
University of Southern California
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
jennifer raymond, Children's Hospital Los Angeles

Brief 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 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:

  1. Standard Care - No Group
  2. Standard Care - Virtual Team Clinic Group
  3. Team Clinic Care - No Group
  4. 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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Team Clinic Care Other: Standard Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Team Clinic Care: No VTC Groups

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

Other: Team Clinic Care

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


Team Clinic: Virtual Team Clinic Group

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

Other: Team Clinic Care

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 Care: No VTC Groups
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).
Other: Standard Care
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.

Standard Care: Virtual Team Clinic

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

Other: Standard Care
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.




Primary Outcome Measures :
  1. Hemoglobin A1C at Baseline [ Time Frame: baseline to 12 months ]
    Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

  2. Hemoglobin A1C Progression [ Time Frame: For each visit (until the end of study) - 12 months ]
    Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

  3. Number of Team Clinic Care cohort participants attending appointments [ Time Frame: 12 months ]
    Attendance will be recorded for each Team Clinic visit

  4. Number of Virtual Team Clinic Care cohort participants completing appointments [ Time Frame: 12 months ]
    Attendance will be recorded for each Virtual Team Clinic Visit

  5. Number of Team Clinic Care cohort participants completing appointments [ Time Frame: 12 months ]
    Electronic Medical Record (EMR) Abstraction

  6. 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

  7. 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.

  8. 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

  9. 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?"

  10. Number of Standard Clinic cohort participants completing appointments [ Time Frame: 12 months ]
    Attendance will be recorded for each standard care visit

  11. Number of Standard Care cohort participants completing appointments [ Time Frame: 12 months ]
    Electronic Medical Record (EMR) Abstraction


Secondary Outcome Measures :
  1. Number of Team Clinic Care cohort participants with diabetic ketoacidosis [ Time Frame: 12 months ]
    Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR

  2. Number of Standard Care cohort participants with diabetic ketoacidosis [ Time Frame: 12 months ]
    Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR

  3. Number of Team Clinic cohort participants with severe hypoglycemia [ Time Frame: 12 months ]
    Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR

  4. Number of Standard Care cohort participants with severe hypoglycemia [ Time Frame: 12 months ]
    Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR

  5. Diabetes Family Conflict Scale [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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.

  6. Problem Areas in Diabetes in Caregivers [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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.

  7. Problem Areas in Diabetes in Teens [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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.

  8. Patient - Practitioner Orientation Scale [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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.

  9. Cost to Instituition [ Time Frame: 12 months ]
    Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"

  10. Cost to Institution - Standard care [ Time Frame: 12 months ]
    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?"

  11. Cost to Institution - Team Clinic [ Time Frame: 12 months ]
    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?"

  12. Cost to Institution - Clinic Costs [ Time Frame: 12 months ]
    Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient.

  13. Cost to Institution - Team Costs [ Time Frame: 12 months ]
    Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained (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.

  14. Cost to Institution [ Time Frame: 12 months ]
    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."

  15. Clinical Efficiency [ Time Frame: 12 months ]
    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.

  16. Diabetes Strengths and Resilience Measure for Children [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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.

  17. Diabetes Strengths and Resilience Measure for Teens [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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.

  18. PROMIS - Peds Peer Relationships [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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)

  19. PROMIS - Peds Family Relationships [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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)

  20. PROMIS - Emotional Support [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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)

  21. PROMIS - Instrumental Support [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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)

  22. PROMIS - Informational Support [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    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)


Other Outcome Measures:
  1. Socio-Demographic History [ Time Frame: At 0 (baseline) ]
    Self-reported demographic history (gender, age, race, household income, etc) will be collected.

  2. Medical History [ Time Frame: 12 months ]
    General health history via self report and EMR

  3. Diabetes Treatment Regimen - glucometer [ Time Frame: 12 months ]
    Diabetes treatment regimen assessed through blood glucose checks per day from glucometer downloads will be collected from devices and EMR.

  4. Diabetes Treatment Regimen - insulin pump [ Time Frame: 12 months ]
    Diabetes treatment regimen assessed through insulin boluses per day from insulin pump downloads will be collected from devices and EMR.

  5. Diabetes Treatment Regimen - continuous glucose monitors [ Time Frame: 12 months ]
    Diabetes treatment regimen assessed through percentage of glucose values low, in target, or high for patients on continuous glucose monitors will be collected from devices and EMR.

  6. Self-care and mobility as assessed using the EuroQOL five dimensions five levels youth (EQ-5D-Y) questionnaire [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.

  7. The Child Health Utility [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    The Child Health Utility 9 dimensions assesses health-related quality of life (HRQoL). Multiple choice used to capture respondents' endorsement of particular statements about experience. "I don't feel [upset] today," "I feel a little bit [upset] today," "I feel a bit [upset] today," "I feel quite [upset] today," "I feel very [upset] today"

  8. Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Composed of 8 items to screen, diagnose, and measure the severity of depression.

  9. Shared Medical Appointments - Patient/AYA [ Time Frame: baseline to 12 months ]
    Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments.

  10. Shared Medical Appointments- Parent/caregiver [ Time Frame: baseline to 12 months ]
    Likert scale;"Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments.

  11. Self Care - Related to Diabetes as assessed by Self-Care questionnaire [ Time Frame: baseline to 12 months ]
    Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"

  12. Diabetes Family Responsbility Questionnaire - Parent [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Asseses how adolescents with T1D and their families/caregivers share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management.

  13. Diabetes Family Responsbility Questionnaire - Teen [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Asseses how parents/caregivers of children/teens living with T1D share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management.

  14. Clinical Variables [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Polar; Yes or No questionnaire. Data extracted from EMR : cholesterol, high density lipoprotein, triglycerides, smoking status, nephropathy, microalbuminaria, macroalbuminaria, end-stage renal disease (death from end-stage renal disease), neuropathy, peripheral arterial disease (low extremity amputation), retinopathy (proliferative retinopathy), macular edema, blindness, angina, myocardial infarction, stroke, heart failure, revascularization (Coronary artery bypass grafting, PCA, and stenting). If answered "yes" for the following: ergosterol, HDL,microalbuminaria, and macroalbuminaria, values will be recorded.

  15. ADA and CCS standards [ Time Frame: 12 months ]
    EMR abstraction: Questions assess compliance with ADA and CCS standards when patients have contact with all team members annually. This will be noted with polar questions "Yes" or No." This will be tracked for all patients in the study (e.g., Team Clinic and Standard Clinic).

  16. COVID-19 Questionnaires [ Time Frame: At 0 (Baseline) and 12 months (after visit 4) ]
    Impact of COVID-19 pandemic assessed using the COVID-19 Questionnaire. Open ended questions that ask about COVID impact on child's and parent/caregiver "T1D management," "mood," "changes"

  17. Single Item Literacy Scale [ Time Frame: At 0 (Baseline) and 12 months (after visit 4) ]
    Literacy assessed using the Single Item Literacy Scale. Multiple choice question asking about suppoort needed with reading materials. Options, "never," "rarely," "sometimes," "often," "always"

  18. Provider Centered Care Observation Form (PCOF) [ Time Frame: 12 months ]
    Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintain Relationship Throughout the Visit," "Collaborative upfront agenda setting," "Maintain Efficiency using transparent thinking and respectful interruption," "Gathering information," "Assessing patient or family perspective on health," "Electronic Medical Record Use," "Physical Exam"

  19. Facilitator Centered Care Observation Form (PCOF) [ Time Frame: 12 months ]
    Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintains Relationship Trhoughout the Visit," "Session Introduction and Icebreaker," "Session Preparation," "Gathering Information," "Assessing Patient or Family Persepctive on Health/Understanding Context," "Blood Glucose Charting," "Blood Glucose Discussion," "Activity Kit Review"

  20. Provider/Facilitator Session Feedback Form: [ Time Frame: 12 months ]
    Assess provider experience during clinic visit and patient-center delivery. Multiple choice, "Establishing Rapport and Maintaining Relationship," "Agenda-setting, Thinking Out-Loud, and Collaboration," "Gathering Information and Understanding Context," "EMR Review and Physical Exam," "Promoting Behavior Change or Self-Management," "Collaborative Planning and Closure," "None of these"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  1. Diagnosis of type 1 diabetes > 6 month duration
  2. Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
  3. Not currently participating in other group interventions
  4. English speaking

Exclusions

  1. Severe behavioral or developmental disabilities in parent or child
  2. Severe psychological diagnoses in parent or child that would make group participation difficult
  3. Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
  4. Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190368


Contacts
Layout table for location contacts
Contact: Valerie Ruelas, MSW 323-361-8416 vruelas@chla.usc.edu
Contact: Jaquelin Flores Garcia, BS, MPH 323-361-4842 ext 14842 jfloresgarcia@chla.usc.edu

Locations
Layout table for location information
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Contact: Jaquelin Flores Garcia, BS, MPH    323-361-4842    jfloresgarcia@chla.usc.edu   
Contact: Valerie Ruelas, MSW    323-361-8416    vruelas@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
University of Southern California
Cedars-Sinai Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jennifer K Raymond, MD, MCR Children's Hospital Los Angeles
Publications:
Peters 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. Erratum in: Diabetes Care. 2012 Jan;35(1):191.
Noffsinger 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.
Evans 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.
Continous Glucose Monitoring (CGM) as a CCS/GHPP Program Benefit [press release]. 3/6/2017.
Rubin RY-H, D; Peyrot, M. Parent-child responsibility and conflict in diabetes care (Abstract) Diabetes Care. 1989;38:28A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: jennifer raymond, MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT04190368    
Other Study ID Numbers: CHLA-19-00062
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed, and requestors will be required to sign a Data Access Agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by jennifer raymond, Children's Hospital Los Angeles:
Adolescents
Young Adults
Group Medical Visits
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases