Reducing Disparities in Late Life Depression and Metabolic Syndrome (BRIGHTEN-Heart)
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|ClinicalTrials.gov Identifier: NCT01428791|
Recruitment Status : Unknown
Verified May 2015 by Rush University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : September 5, 2011
Last Update Posted : May 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Metabolic Syndrome X Overweight Obesity Hypertension Hyperglycemia Dyslipidemias||Behavioral: Generations older adult membership program Behavioral: BRIGHTEN Heart Virtual Team intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||BRIGHTEN Heart: Reducing Disparities in Late Life Depression and Metabolic Syndrome|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Generations older adult member 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.
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. • 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. • Assistance with referral to community programs such as physical activity, driver safety events, and mind-body connection workshops.
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.
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 including psychologist, social worker, occupational therapist, pharmacist, chaplain, dietitian, geriatric psychiatrist, and 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 Case Management. • Evidence Based Psychotherapy, as needed, delivered by supervised geriatric psychology and social work fellows.
- Clinical Depression Scores, as measured by PHQ-9 [ Time Frame: 6 months ]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
- Cardiometabolic risk factors [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428791
|United States, Illinois|
|Cook County Health and Hospital System|
|Chicago, Illinois, United States, 60612|
|Mercy Hospital and Health System|
|Chicago, Illinois, United States, 60616|
|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|