Implementation of Team Clinic for Type 2 Diabetes (TCT2)

Официальное название

Implementation of Team Clinic for Type 2 Diabetes (TCT2): A Randomized Standard Care-controlled Two-site 80-subject Clinical Trial of Shared Medical Appointment Model for Adolescents With Type 2 Diabetes

Обзор

The goal of this clinical trial is to learn if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question\[s\] it aims to answer are: * Is shared medical appointments an acceptable care delivery model for this population? * Does shared medical appointment improve psychosocial outcomes for this population? Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

Вмешательства

• Другое Standard of Care
  Multidisciplinary team based care every 3 months.
• Поведенческое Shared Medical Appointments
  Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.

Первичные конечные точки

• Average number of clinics attended over 1 year period to be recorded by Study Coordinator [Срок оценки: 1 year]
• Change in HbA1c for patients from baseline to end of study [Срок оценки: 1 year]
• Clinic Satisfaction [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Depression score [Срок оценки: 1 year]
• Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year [Срок оценки: 1 year]
• Diabetes distress for patients over 1 year period [Срок оценки: 1 year]
• Change in dietary intake for patients before and after delivery of the dietary intervention [Срок оценки: three months]
• Beliefs about Medicines for patients and parent/caregiver over one year [Срок оценки: 1 year]
• Quality of life for patients [Срок оценки: 1 year]

Критерии участия

Patient/AYA Participants

Критерии включения

• Receives care for type 2 diabetes at either CHLA or UCSF
• English speaking youth
• Youth prescribed medication for type 2 diabetes
• English or Spanish speaking caregivers
• Age 12 to 18 years old at the time of enrollment
• Willingness to attend clinic visits and participate in group session (if randomized to Team Clinic), complete surveys

Критерии исключения

• Participants who are non-verbal or unable to participate in group activities and discussions
• Pregnancy
• Inability or unwillingness of individual or legal guardian/representative to give written informed assent/consent

Caregiver/Parents Participants

Критерии включения

• Has a child between the ages of 12 and up to 18 at the time of enrollment who receives care for T2D in the endocrinology clinic at CHLA. The child must provide consent/assent to participate as a youth participant.
• Speaks English of Spanish. Over 95% of our T2D population speaks one of those two languages. Our facilitator will be bilingual in English and Spanish. It is not feasible for the facilitator to also speak another language. Having a language interpreter for discussion groups will affect the dynamics and flow of the group session
• Willingness to participate in group session (if their child is randomized to Team Clinic) and complete surveys.

Критерии исключения

-Inability or unwillingness of individual to give written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Children's Hospital Los Angeles — Los Angeles
• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06923046 · CHLA-25-00070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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