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临床试验/NCT03916016
NCT03916016已完成不适用

Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients

Health Resources in Action, Inc.0 个研究点目标入组 585 人开始时间: 2015年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
585
主要终点
Blood Pressure

研究概览

简要总结

This study evaluated whether uninsured patients living at or below 200% of the federal poverty level who received enhanced, culturally-relevant, integrated behavioral health services were more likely to improve health outcomes after 12 months compared to similar patients receiving usual care from Hope Family Health Center (HFHC), a charitable community clinic. The study employed a randomized control trial (RCT) design where intervention participants receiving integrated care at HFHC were compared to control participants receiving usual care at HFHC. Patients were placed in each group using simple random assignment. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data were subsequently collected at 6-month and 12-month follow-up points.

详细描述

This study evaluated whether uninsured patients living at or below 200% of the federal poverty level who received enhanced, culturally-relevant, integrated behavioral health services were more likely to improve health outcomes after 12 months compared to similar patients receiving usual care from Hope Family Health Center (HFHC), a charitable community clinic. The study employed a randomized control trial (RCT) design where intervention participants receiving integrated care at HFHC were compared to control participants receiving usual care at HFHC. Patients were placed in each group using simple random assignment. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data were subsequently collected at 6-month and 12-month follow-up points. The primary outcomes of interest were systolic and diastolic blood pressure and depressive symptoms. Additional secondary outcomes of interest were HbA1c and BMI. These outcomes were analyzed as continuous variables using linear regression with backward model selection. Longitudinal analyses were also conducted using a likelihood-based approach to general linear mixed models. The participants (1) resided in Cameron, Hidalgo, Willacy, or Starr County, (2) were eligible to receive behavioral health services from HFHC (e.g., uninsured, living at or below 200% of the federal poverty level, residence in HFHC's service area), and (3) had a diagnosis of hypertension (blood pressure of 140/90 mm Hg or higher) and/or obesity (body mass index of 30.0 or higher) and/or poorly controlled diabetes (HbA1c over 6.8) and/or moderate depression (score of 10 or above on PHQ-9).

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

  • Reside in Cameron, Hidalgo, Starr, or Willacy County
  • Were eligible to receive behavioral health services from HFHC (e.g., uninsured, living at or below 200% of the federal poverty level, residence in HFHC's service area)
  • Have a diagnosis of one or more chronic conditions:
  • Hypertension (blood pressure of 140/90 mmHg or higher)
  • Obesity (body mass index of 30.0 or higher)
  • Poorly controlled diabetes (HbA1c over 6.8%)
  • Moderate depression (score of 10 or above on PHQ-9)

排除标准

  • Not actively suicidal at time of enrollment

研究组 & 干预措施

Intervention Group

Experimental

The intervention group received enhanced integrated behavioral health care.

干预措施: Enhanced Integrated Behavioral Health Care (Behavioral)

Control Group

Active Comparator

The control group received care as usual only.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Blood Pressure

时间窗: One year

Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).

次要结局

  • Body mass index(One year)
  • Blood glucose concentration(One year)
  • Depressive Symptoms(One year)

研究者

发起方
Health Resources in Action, Inc.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Errichetti

Director, Research and Evaluation

Health Resources in Action, Inc.

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