Reducing Disparities in Late Life Depression and Metabolic Syndrome

NCT01428791 | Completed

• 1 other identifier: 1P50HL105189-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depressive Symptoms; Metabolic Syndrome X; Overweight; Obesity; Hypertension; Hyperglycemia; Dyslipidemias

Keywords

Geriatrics; Older adults; Health Disparities; Health Services for the Aged; Interdisciplinary Health Team; Depressive symptoms; Metabolic Syndrome X; Overweight; Obesity; Hypertension; Hyperglycemia; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Clinical Depression Scores, as measured by PHQ-9

  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

  6 months

Secondary Outcomes (1)

• Cardiometabolic risk factors

  6 months

Study Arms (2)

Generations older adult member program

ACTIVE COMPARATOR

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

BRIGHTEN Heart Virtual Team

EXPERIMENTAL

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

Interventions

Generations older adult membership program BEHAVIORAL

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.

Generations older adult member program

BRIGHTEN Heart Virtual Team intervention BEHAVIORAL

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.

BRIGHTEN Heart Virtual Team

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (2)

Cook County Health and Hospital System

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Health System

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• Emery-Tiburcio EE, Rothschild SK, Avery EF, Wang Y, Mack L, Golden RL, Holmgreen L, Hobfoll S, Richardson D, Powell LH. BRIGHTEN Heart intervention for depression in minority older adults: Randomized controlled trial. Health Psychol. 2019 Jan;38(1):1-11. doi: 10.1037/hea0000684. Epub 2018 Nov 1.

  PMID: 30382712 DERIVED

MeSH Terms

Conditions

Depression; Metabolic Syndrome; Overweight; Obesity; Hypertension; Hyperglycemia; Dyslipidemias

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 5, 2011
• Study Start: March 1, 2011
• Primary Completion: June 30, 2014
• Study Completion: December 16, 2014
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

US (2)