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Sí Texas Hope Family Health Center

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ClinicalTrials.gov Identifier: NCT03916016
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Methodist Healthcare Ministries of South Texas, Inc.
Social Innovation Fund
Information provided by (Responsible Party):
Karen Errichetti, Health Resources in Action, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Hypertension Diabetes Hypercholesterolemia Depression Obesity Behavioral: Enhanced Integrated Behavioral Health Care Behavioral: Usual Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment group participants were randomized to receive enhanced integrated behavioral health care. Control group participants received care as usual.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

Arm Intervention/treatment
Experimental: Intervention Group
The intervention group received enhanced integrated behavioral health care.
Behavioral: Enhanced Integrated Behavioral Health Care
The intervention involved moving from HFHC's previous collaborative model, where medical and behavioral providers worked with each other episodically, to a more fully integrated collaborative care model with care coordination, shared treatment plans, shared service provision, and shared record keeping. To achieve this enhanced level of integration, HFHC changed its current primary care workflow to include a behavioral health specialist who conducted assessments, provided initial counseling (individual or group), and coordinated referrals to care management and/or community-based health services.

Active Comparator: Control Group
The control group received care as usual only.
Behavioral: Usual Care
A collaborative model where medical and behavioral providers worked with each other episodically




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: One year ]
    Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: One year ]
    Height and weight were measured at baseline, and body mass index was calculated.

  2. Depressive Symptoms [ Time Frame: One year ]
    Score calculated based on responses to the Patient Health Questionnaire-9. The PHQ-9 has a total possible score of 27. Each of the nine questions is assigned a value of 0, 1, 2, or 3. The total score is the sum of individual questions' scores. The PHQ-9 scoring criteria is categorized as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27) depression.

  3. Blood glucose concentration [ Time Frame: One year ]
    Blood glucose concentration was measured via blood test for HbA1c as a continuous variable



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Karen Errichetti, Director, Research and Evaluation, Health Resources in Action, Inc.
ClinicalTrials.gov Identifier: NCT03916016    
Other Study ID Numbers: 100002
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Errichetti, Health Resources in Action, Inc.:
Integrated Behavioral Health
Integrated Care
Volunteer Clinic
Additional relevant MeSH terms:
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Hypercholesterolemia
Chronic Disease
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes