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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Average number of clinics attended over 1 year period to be recorded by Study Coordinator
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient/AYA Participants
- •Inclusion Criteria:
- •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
排除标准
- •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
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •Inability or unwillingness of individual to give written informed consent
结局指标
主要结局
Average number of clinics attended over 1 year period to be recorded by Study Coordinator
时间窗: 1 year
Data collected is the number of patient visits to the clinic.
Change in HbA1c for patients from baseline to end of study
时间窗: 1 year
Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period
Clinic Satisfaction
时间窗: 1 year
Patient participants will complete satisfaction survey at the end of each visit using a 5-point Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5.
次要结局
- Depression score(1 year)
- Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year(1 year)
- Diabetes distress for patients over 1 year period(1 year)
- Change in dietary intake for patients before and after delivery of the dietary intervention(three months)
- Beliefs about Medicines for patients and parent/caregiver over one year(1 year)
- Quality of life for patients(1 year)
研究者
lily chao
Principal Investigator
Children's Hospital Los Angeles