Reducing Disparities in Late Life Depression and Metabolic Syndrome (BRIGHTEN-Heart)
|First Received Date ICMJE||September 1, 2011|
|Last Updated Date||May 12, 2015|
|Start Date ICMJE||March 2011|
|Primary Completion Date||January 2015 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Clinical Depression Scores, as measured by PHQ-9 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Depression has been shown to double both the risk of developing heart disease and mortality risk for persons who do develop heart disease. The Primary Aim of the trial is to document reduction in symptoms of depression in persons receiving the intervention, relative to the control group. The PHQ-9 instrument is the most widely used symptom measure of depression, and has been validated across multiple populations, and in a Spanish-translation as well
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01428791 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Cardiometabolic risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Risk for the development of heart disease will be compared via clinical measures and blood tests. Clinical measurements include Blood Pressure, Weight, and Waist Circumference. Blood tests include Hemoglobin A1c, HDL Cholesterol, LDL Cholesterol, and hsCRP.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Reducing Disparities in Late Life Depression and Metabolic Syndrome|
|Official Title ICMJE||BRIGHTEN Heart: Reducing Disparities in Late Life Depression and Metabolic Syndrome|
Linkages between depression and cardiovascular disease have been well documented. These appear to be more than associations, and may reflect causal relationships through a number of proposed pathways, including decreased physical activity, poor dietary habits, medication non-adherence, and a direct impact on inflammatory mediators. Older adults are affected by both depression and heart disease, with increased risk in African American and Latino elderly.
The BRIGHTEN-Heart trial tests the hypothesis that an enhanced primary care delivery system intervention which provides evidence-based, patient-centered mental health services targeting depression and cardiovascular risk factors can reduce the risk of development of cardiovascular disease in low-income elderly blacks and Hispanics. BRIGHTEN stands for Bridging Resources of a Geriatric Health Team via Electronic Networking, and in this intervention, specialty providers including geropsychologists, social workers, pharmacists, nutritionists, chaplains, occupational therapists, and others collaborate via the internet as a virtual team. The study will determine if such a virtual interdisciplinary clinical team collaboration can reduce depression in older (age ≥ 65) minority adults with comorbid depression and metabolic syndrome.
Chicago has been characterized as one of America's most segregated cities, with many neighborhoods characterized by black and Hispanic populations living in concentrated pockets of poverty. In addition to lowered socioeconomic status, these neighborhoods are also characterized by remarkable health disparities relative to wealthier, predominantly white neighborhoods only a few miles away. Disparities in access to health services contribute to these poorer health outcomes, but are not wholly explanatory.
For cardiovascular disease, the leading cause of death in the US, both black and Hispanic adults have elevated rates of many major risk factors including physical inactivity, obesity, elevated levels of Fasting Blood Glucose, and dyslipidemia. Blacks also have elevated rates of hypertension, and experience well-documented excess mortality rates. Experts are anticipating that, given high prevalence of risk factors, most importantly the metabolic syndrome, similar disparities in cardiovascular mortality may soon emerge for Hispanics as well.
Beyond cardiovascular disease, these populations face psychosocial challenges such as poverty, unemployment, societal racism, and high rates of major and traumatic life stress, all of which can contribute to high rates of depression and anxiety symptoms. Even the physical environment adds to the levels of stress: empty buildings that can become criminal and drug havens, boarded up storefronts, lack of groceries providing access to fresh fruits and vegetables (so-called "food deserts"). Disparities in access to health services, and these environmental conditions, as well as personal and familial factors associated with poverty are related to health disparity outcomes in complex ways that are only beginning to be understood.
Linkages between depression and cardiovascular disease have been well documented. These appear to be more than associations, but may reflect causal relationships through a number of proposed pathways, including decreased physical activity, poor dietary habits, medication non-adherence, and a direct impact on inflammatory mediators.
Aging is often associated with worsening of health disparities. The most vulnerable subpopulation among the urban poor are the elderly, as they are naturally vulnerable due to old age, compounded by lifetime exposure to poverty, and diminished defenses against violence in their homes or neighborhoods, including routes to health service providers.
To date, health care interventions targeting specific individual risk factors in the elderly have had only limited success in reducing health disparities in cardiovascular disease. The investigators hypothesize that this is due to two reasons. First, changes in the healthcare system are needed that feature multidisciplinary teams rather than individual practitioners. Second, treatment of cardiovascular risk factors requires attention to the patient's emotional state to guard against the possibility that providers and patients are working at cross-purposes; that is, the provider wants the patient to take action to improve long-term survival, while the patient is experiencing low self-esteem, hopelessness, helplessness, or even a passive or active wish to die. Reducing the risk of heart disease in this complex bio-psychosocial context requires more than prescribing the right medication or recommending that individuals modify their diet and exercise. The investigators hypothesize that a multi-level intervention targeting both the healthcare system and the individual's psychosocial and behavioral risk factors may succeed where past interventions have failed.
The investigators therefore propose testing the hypothesis that an enhanced primary care delivery system intervention which provides evidence-based, patient-centered mental health services targeting depression and cardiovascular risk factors can reduce the risk of development of cardiovascular disease in low-income elderly blacks and Hispanics. Researchers at Rush University Medical Center have developed and tested several "virtual" interdisciplinary team interventions, in which healthcare providers communicate as a team via e-mail, telephone, fax, or video conferencing. The first of these, the Virtual Integrated Practice project demonstrated that primary care practices could partner with community-based teams to improve care of older adults with chronic illness. A subsequent program called BRIGHTEN (Bridging Resources of a Geriatric Health Team via Electronic Networking) enhanced the assessment and treatment of late life depression and anxiety in primary care. The proposed "BRIGHTEN Heart study" will determine if a virtual interdisciplinary clinical team (BRIGHTEN Heart) can reduce depression in older (age ≥ 65) minority adults with comorbid depression and metabolic syndrome. The overall purpose of this study is to reduce racial disparities in cardiovascular morbidity and mortality in black and Hispanic elderly by effectively controlling behavioral and psychosocial risk factors.
A second, exploratory purpose of the study is to better understand the impact of current major stressors and lifetime and current traumatic stressors, as these may be "hidden" factors that impact emotional state, individual behavior, access to care, and intervention adherence. It is our goal to them incorporate what the investigators learn about the impact of major and traumatic stressors into later intervention as part of our overall Center efforts.
Compared to an educational group, older minority patients with symptoms of depression and comorbid metabolic syndrome receiving the BRIGHTEN Heart virtual team intervention will demonstrate
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||250|
|Estimated Completion Date||December 2015|
|Primary Completion Date||January 2015 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||60 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01428791|
|Other Study ID Numbers ICMJE||1P50HL105189-01|
|Has Data Monitoring Committee||No|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Rush University Medical Center|
|Study Sponsor ICMJE||Rush University Medical Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Rush University Medical Center|
|Verification Date||May 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP