CompletedNot Applicable

Reducing Disparities in Late Life Depression and Metabolic Syndrome

United States250 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range

60 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Depression Scores, as measured by PHQ-9

Timeframe: 6 months

Trial details

NCT IDNCT01428791

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06-30

View on ClinicalTrials.gov More Depressive Symptoms trials