Reducing Disparities in Late Life Depression and Metabolic Syndrome (BRIGHTEN-Heart)

This study is currently recruiting participants.
Verified January 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01428791
First received: September 1, 2011
Last updated: January 24, 2014
Last verified: January 2014

September 1, 2011
January 24, 2014
March 2011
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01428791 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Reducing Disparities in Late Life Depression and Metabolic Syndrome
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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Symptoms
  • Metabolic Syndrome X
  • Overweight
  • Obesity
  • Hypertension
  • Hyperglycemia
  • Dyslipidemias
  • Behavioral: Generations older adult membership program

    Rush Generations is a membership program for older adults emphasizing chronic disease prevention and management through a wide range of health and aging-related programs. Participants assigned to the Generations intervention are actively encouraged to participate in activities, including:

    • RUSH-based lectures by experts in the fields of health and aging providing practical information and resources on physical and mental health, functional status, and social support. Twice per month.
    • Individual and family consultations with social work staff.
    • Health fairs with a variety of assessment services and information about community-based social service and health agencies. Twice per year.
    • Assistance with referral to community programs such as physical activity, driver safety events, and mind-body connection workshops.
  • Behavioral: BRIGHTEN Heart Virtual Team intervention

    BRIGHTEN Heart provides an interdisciplinary team evaluation of physical and mental health and on-going support for mental health & health behavior change for 6 - 12 months, including:

    • Comprehensive health risk assessment by a licensed social worker, including physical, mental, and functional status.
    • Virtual team case review and recommendations by interdisciplinary team of health professionals including psychologist, social worker, occupational therapist, pharmacist, chaplain, dietitian, geriatric psychiatrist, and the patient's primary care physician.
    • Development of Patient Centered Action Plan, in which the social worker assists the patient in prioritizing recommendations.
    • Monthly telephone calls by the social worker to support implementation of Action Plan and to provide ongoing Case Management.
    • Evidence Based Psychotherapy, as needed, delivered by supervised geriatric psychology and social work fellows. Duration determined by monthly assessments.
  • Active Comparator: Generations older adult membership program
    Rush Generations is a membership program for older adults, providing chronic disease prevention and management through educational programming, civic engagement, and individual and family consultations with social work staff.
    Intervention: Behavioral: Generations older adult membership program
  • Experimental: BRIGHTEN Heart Virtual Team
    BRIGHTEN Heart provides older adults with an interdisciplinary team evaluation of physical and mental health and on-going support for mental health and health behavior change for a minimum of six months. The five core components of the BRIGHTEN intervention consist of: 1) Assessment; 2) Virtual team case review; 3) Patient centered action planning; 4) Plan implementation, and; 5) When indicated, short-term evidence-based geriatric specialty psychotherapy.
    Intervention: Behavioral: BRIGHTEN Heart Virtual Team intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 60 years of age.
  • Overweight or Obese as documented by BMI greater than 25.0.
  • Presence of Depression symptoms, as determined by having a PHQ-9 score of 8 or more.
  • Receiving primary care through a participating safety net clinic (public clinic or FQHC)

Exclusion Criteria:

  • Below the age of 60 years old at time of enrollment.
  • Lack decisional capacity (due to dementia, active psychosis, or other cause).
  • Are currently under active behavioral treatment of a psychologist or psychiatrist for any reason.
  • Lack regular access to a telephone in their home (including cell phone).
  • Are enrolled in another intervention trial
Both
60 Years and older
Yes
Contact: Steven K Rothschild, MD 312 942 3476 steven_k_rothschild@rush.edu
Contact: Erin Emery, PhD 312 942 6294 erin_emery@rush.edu
United States
 
NCT01428791
1P50 HL105189-01
No
Rush University Medical Center
Rush University Medical Center
Not Provided
Principal Investigator: Steven K Rothschild, MD Department of Preventive Medicine, Rush University Medical Center
Principal Investigator: Erin Emery, PhD Department of Behavioral Sciences, Rush University Medical Center
Rush University Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP