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Trial record 75 of 2473 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Team Clinic: Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents 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 : December 9, 2019
Sponsor:
Collaborators:
University of Colorado Denver School of Medicine Barbara Davis Center
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
jennifer raymond, Children's Hospital Los Angeles

Brief Summary:
This study is a 12-month parallel group randomized control trial (RCT) comparing an intervention group of middle school aged individuals with type 1 diabetes and their caregivers participating in Team Clinic with a control group following usual care (without Team Clinic)

Condition or disease Intervention/treatment Phase
Type1 Diabetes Other: Team Clinic 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 aged individuals with Type 1 Diabetes and their caregivers. Visits use a shared medical appointment model staffed by a multidisciplinary team of diabetes care providers. Intervention participants will attend quarterly visits (1 visit every 3 months) and participate in thematic group visits 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a 12-month parallel group randomized control trial (RCT) comparing an intervention group participating in Team clinic with a control group following usual care (without Team Clinic)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Team Clinic: Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents With Type 1 Diabetes
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Team Clinic
Participants attend quarterly visits (1 visit every 3 months) and participate in thematic group visits 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.
Other: Team Clinic

Patients will check in for vitals and see their medical provider while their caregiver(s) proceed to their thematic group visit. At the end of the thematic group visit, the patient and caregiver(s) will see the medical provider together to review treatment plans and set goals for the next appointment.

Subjects and their caregivers will attend the following thematic group visits:

  1. Energy Training - Glycemic Control, Physical Activity, and Nutrition
  2. Proficiency Training - Skills Station: Carb Counting, Interpreting Continuous Glucose Monitor Pattern Management, Sick Day, Insulin Injections
  3. Resilience Training - Diabetes Burnout and Bounce-Back
  4. Balance Training - Problem Solving Skills, Monitoring and Taking Medication

No Intervention: Usual 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. Change from baseline Hemoglobin A1C at 12 months [ Time Frame: baseline to 12 months ]
    HbA1c is measured with the DCA 2000 point-of-care analyzer

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

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

  4. 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

  5. Patient and Provider 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.

  6. 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

  7. 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?"


Secondary Outcome Measures :
  1. Number of Team Clinic 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 Usual 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 Usual 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-C). 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: [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 - In Person [ Time Frame: [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 appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"

  11. Cost to Institution - online [ Time Frame: [Time Frame: 12 months] ]
    Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to in person, standard-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 [ Time Frame: [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 [ Time Frame: [Time Frame: 12 months] ]
    Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, "camera and mic," "loading Webex platform."


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

  7. Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.

  8. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: At 0 (baseline) and 12 months (after visit 4) ]
    Composed of 9 items to screen, diagnose, and measure the severity of depression.

  9. Shared Medical Appointments - Patient [ 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. 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.

  12. 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.

  13. 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, 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.



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Ages Eligible for Study:   10 Years to 14 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 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
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Contact: Valerie Ruelas, MSW 323-361-8416 vruelas@chla.usc.edu
Contact: Joselyn S Ruiz, BA, BS 323-361-8884 ext 18884 joselynruiz@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Joselyn S Ruiz, BA, BS    323-361-8884 ext 18884    joselynruiz@chla.usc.edu   
Contact: Valerie Ruelas, MSW    323-361-8416    vruelas@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
University of Colorado Denver School of Medicine Barbara Davis Center
Cedars-Sinai Medical Center
Investigators
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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.

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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     History of Changes
Other Study ID Numbers: CHLA-19-00062
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
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.

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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
Group Medical Visits
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases