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临床试验/NCT05570734
NCT05570734招募中不适用

Latinos Understanding the Need for Adherence in Diabetes Using Care Coordination, Integrated Medical and Behavioral Care and E-Health

San Diego State University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Psychological Distress - Depression

研究概览

简要总结

Latinos Understanding the Need for Adherence in Diabetes using Care Coordination, Integrated Medical and Behavioral Care and E-Health (LUNA-E) is a randomized controlled trial (RCT) that will test the effectiveness a patient-centered, team-based, primary care intervention with E-Health enhancements in improving glycemic control (primary outcome, hemoglobin A1C level) and psychological distress (secondary outcome; depression, anxiety symptoms).

详细描述

LUNA-E will help advance our understanding of optimal approaches to diabetes healthcare services in a large, growing, US population at high risk for diabetes and related complications. If shown effective, LUNA-E has high potential for broad scaling and dissemination due to its community partnered approach, use of technology, and implementation within a large, exemplar federally qualified health center (FQHC) environment. The study's total sample size is 600, with 400 consented and enrolled in the randomized controlled trial (RCT). An additional 200 participants will be identified for medical records review and will not undergo study related activities.

The RCT (Arms 1 and 2) targets 400 Latino patients with type 2 diabetes from a local FQHC pool of registered patients. The eligibility criteria are: 1) Latino ethnicity of any race; 2) registered patient of FQHC; 3) > 18 years; 4) type 2 diabetes with hemoglobin A1C (HbA1c) >7.5% in past 90 days; 5) provider approval; 6) not participating in any other diabetes intervention. Biological measurements will be taken at baseline, 3-, 6-, and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study.

For Arm 3,the research team will work with the FQHC IT to query all patients with type 2 diabetes and then identify 200 matched controls, using propensity score matching as guided by the study statistician. Selection criteria will occur after the study has completed recruitment. Only de-identified data will be obtained from the medical records for these individuals. De-identified data will be provided by the FQHC IT department.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self identify as Hispanic/Latino ethnicity of any race
  • Registered patient of federally qualified health center
  • 18 years of age or older
  • Type 2 diabetes with hemoglobin A1C (HbA1c) >7.5% in past 90 days
  • Approval from primary care provider
  • Not currently enrolled/participating in any other diabetes intervention program(s)

排除标准

  • Actively being treated for cancer or Parkinson's Disease
  • Pregnant or nursing (temporary exclusion, may qualify 6-months postpartum)
  • Have plans to move out of the area in the next 12 months
  • Have other existing mental or physical health problems so severe as to prohibit informed consent and participation
  • Have severe diabetes complications (e.g., renal disease, or on dialysis)

结局指标

主要结局

Psychological Distress - Depression

时间窗: 6-months post randomization

Change psychological distress (depression symptoms) among Latino patients with type 2 diabetes via the LUNA-E intervention. The Personal Health Questionnaire-8 (PHQ-8) will be used to assess depression symptomatology. Response options range from not at all (0) to nearly every day (3). Item scores are summed (range 0-24) with higher scores indicating more severe depression symptoms.

Psychological Distress - Anxiety

时间窗: 6-months post randomization

Change psychological distress (anxiety symptoms) among Latino patients with type 2 diabetes via the LUNA-E intervention. The Generalized Anxiety Disorder Questionnaire (GAD-7) will be used to measure anxiety symptomatology. Response options range from not at all (0) to nearly every day (3). Item scores are summed (range 0-21) with higher scores indicating more severe anxiety symptoms.

Hemoglobin A1C (HbA1c) Blood Value

时间窗: 6-months post randomization

Change glycemic control among Latino patients with type 2 diabetes through an innovative patient centered, team-based, highly integrated primary care intervention (LUNA-E).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Talavera

Professor

San Diego State University

研究点 (2)

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