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Depressive SymptomsBRIGHTEN-HeartNCT01428791

Reducing Disparities in Late Life Depression and Metabolic Syndrome

A study testing Generations older adult membership program and BRIGHTEN Heart Virtual Team intervention in people with Depressive Symptoms and Metabolic Syndrome X, run by Rush University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 to 110 yearsHealthy volunteers can take part
What is being tested?
Generations older adult membership program and BRIGHTEN Heart Virtual Team intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
2 sitesUnited States
Study dates
Mar 2011to 16 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Cook County Health and Hospital System

    Chicago, Illinois, 60612

  • Mercy Hospital and Health System

    Chicago, Illinois, 60616

Other trials in United States

About this study

Official title: 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.

Read the detailed 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
Being tested
Generations older adult membership program, BRIGHTEN Heart Virtual Team intervention
Keywords
Geriatrics, Older adults, Health Disparities, Health Services for the Aged, Interdisciplinary Health Team, Depressive symptoms, Metabolic Syndrome X, Overweight, Obesity, Hypertension, Hyperglycemia, Dyslipidemias
Medical subject headings
Depression, Metabolic Syndrome, Overweight, Obesity, Hypertension, Hyperglycemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Generations older adult membership programBehavioural

    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.
  • BRIGHTEN Heart Virtual Team interventionBehavioural

    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.
Study groups in NCT01428791
Study groupRoleWhat they receive
Generations older adult member programActive comparatorRush 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.
Receives: Behavioral: Generations older adult membership program
BRIGHTEN Heart Virtual TeamExperimentalBRIGHTEN 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.
Receives: Behavioral: BRIGHTEN Heart Virtual Team intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (1)
  1. Cardiometabolic risk factors

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2011 (estimated)
  2. Study startMar 2011
  3. Primary completion30 Jun 2014
  4. Study completion16 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01428791
Sponsor's protocol ID
1P50HL105189-01
Acronym
BRIGHTEN-Heart
Status last verified
Nov 2022
First submitted
1 Sep 2011
Last updated
23 Nov 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30382712

Questions about this trial

What is this clinical trial studying?

A study testing Generations older adult membership program and BRIGHTEN Heart Virtual Team intervention in people with Depressive Symptoms and Metabolic Syndrome X, run by Rush University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Depression Scores, as measured by PHQ-9 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01428791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.

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