Clinical trial NCT03916016: Sí Texas Hope Family Health Center
Official title: Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Hypertension
Diabetes
Hypercholesterolemia
Depression
Obesity
Keywords: Integrated Behavioral Health
Integrated Care
Volunteer Clinic
Lead sponsor: Health Resources in Action, Inc.
Sponsor class: OTHER
Collaborators: name: Methodist Healthcare Ministries of South Texas, Inc.
name: Social Innovation Fund
First posted: 2019-04-16
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group participants were randomized to receive enhanced integrated behavioral health care. Control group participants received care as usual.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Not actively suicidal at time of enrollment

Primary outcomes:
measure: Blood Pressure
timeFrame: One year
Secondary outcomes:
measure: Body mass index
timeFrame: One year
measure: Depressive Symptoms
timeFrame: One year
measure: Blood glucose concentration
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References: