Chronic DiseaseNCT03916016
Sí Texas Hope Family Health Center
A study testing Enhanced Integrated Behavioral Health Care in people with Chronic Disease and Hypertension, run by Health Resources in Action, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Hypertension, Diabetes
- What is being tested?
- Enhanced Integrated Behavioral Health Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2015to 29 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not actively suicidal at time of enrollment
About this study
Official title: Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients
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.
Read the 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).
- Conditions
- Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression, Obesity
- Being tested
- Enhanced Integrated Behavioral Health Care, Usual Care
- Keywords
- Integrated Behavioral Health, Integrated Care, Volunteer Clinic
- Medical subject headings
- Chronic Disease, Hypertension, Diabetes Mellitus, Hypercholesterolemia, Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Integrated Behavioral Health CareBehavioural
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.
Usual CareBehavioural
A collaborative model where medical and behavioral providers worked with each other episodically
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group received enhanced integrated behavioral health care. Receives: Behavioral: Enhanced Integrated Behavioral Health Care |
| Control Group | Active comparator | The control group received care as usual only. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
Measured: One year
Secondary outcomes (3)
Body mass index
Height and weight were measured at baseline, and body mass index was calculated.
Measured: One year
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.
Measured: One year
Blood glucose concentration
Blood glucose concentration was measured via blood test for HbA1c as a continuous variable
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start9 Dec 2015
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Resources in Action, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
- Responsible party
- Principal investigator, Karen Errichetti, Health Resources in Action, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916016
- Sponsor's protocol ID
- 100002
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients
- ClinicalTrials.gov ID
- NCT03916016
- Acronym / sponsor ID
- 100002
- Conditions
- Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression, Obesity
- Keywords
- Integrated Behavioral Health, Integrated Care, Volunteer Clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Health Resources in Action, Inc.University, hospital or other
- Collaborators
- Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment group participants were randomized to receive enhanced integrated behavioral health care. Control group participants received care as usual.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Enhanced Integrated Behavioral Health CareThe intervention group received enhanced integrated behavioral health care. |
| Control Group | Active comparator | Behavioral: Usual CareThe control group received care as usual only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Not actively suicidal at time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Integrated Behavioral Health CareThe 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. | Behavioural | Intervention Group |
| Usual CareA collaborative model where medical and behavioral providers worked with each other episodically | Behavioural | Control Group |
Primary outcome
Blood Pressure
Time frame: One year
Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
3 secondary outcomes
Body mass index
Time frame: One year
Depressive Symptoms
Time frame: One year
Blood glucose concentration
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Integrated Behavioral Health Care in people with Chronic Disease and Hypertension, run by Health Resources in Action, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.