Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01428791 |
| Other study ID # |
1P50HL105189-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2011 |
| Est. completion date |
December 16, 2014 |
Study information
| Verified date |
November 2022 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Study Hypothesis:
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
1. Significant reductions in symptoms of depression [Primary trial outcome]
2. Significant reductions in metabolic syndrome
3. Improved adherence with medications prescribed for medical illnesses
Primary Aim
1. To determine whether BRIGHTEN Heart can reduce depression symptoms in older adults with
the metabolic syndrome
Secondary Aims
2. To determine whether the BRIGHTEN Heart intervention can result in reduced prevalence of
metabolic syndrome as compared to a control population
3. To test the mediating hypothesis that the BRIGHTEN Heart intervention results in
improvements in adherence with medications
Exploratory Aim
4. To explore the impact of trauma and major life stressors on the results of the
intervention
