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Sí Texas Hope Family Health Center

Primary Purpose

Chronic Disease, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Integrated Behavioral Health Care
Usual Care
Sponsored by
Health Resources in Action, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring Integrated Behavioral Health, Integrated Care, Volunteer Clinic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    The intervention group received enhanced integrated behavioral health care.

    The control group received care as usual only.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Body mass index
    Height and weight were measured at baseline, and body mass index was calculated.
    Depressive Symptoms
    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.
    Blood glucose concentration
    Blood glucose concentration was measured via blood test for HbA1c as a continuous variable

    Full Information

    First Posted
    April 12, 2019
    Last Updated
    April 18, 2019
    Sponsor
    Health Resources in Action, Inc.
    Collaborators
    Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03916016
    Brief Title
    Sí Texas Hope Family Health Center
    Official Title
    Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 9, 2015 (Actual)
    Primary Completion Date
    March 29, 2018 (Actual)
    Study Completion Date
    March 29, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Health Resources in Action, Inc.
    Collaborators
    Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression, Obesity
    Keywords
    Integrated Behavioral Health, Integrated Care, Volunteer Clinic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    585 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    The intervention group received enhanced integrated behavioral health care.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    The control group received care as usual only.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Integrated Behavioral Health Care
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    A collaborative model where medical and behavioral providers worked with each other episodically
    Primary Outcome Measure Information:
    Title
    Blood Pressure
    Description
    Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Body mass index
    Description
    Height and weight were measured at baseline, and body mass index was calculated.
    Time Frame
    One year
    Title
    Depressive Symptoms
    Description
    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.
    Time Frame
    One year
    Title
    Blood glucose concentration
    Description
    Blood glucose concentration was measured via blood test for HbA1c as a continuous variable
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Sí Texas Hope Family Health Center

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