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NCT01428791 · ClinicalTrials.gov registry record · NA

Reducing Disparities in Late Life Depression and Metabolic Syndrome

A NA study, sponsored by Rush University Medical Center.

Completed
Registry status
NA
Development phase
250
Enrollment target

NCT01428791: Completed NA study, sponsored by Rush University Medical Center.

NCT01428791 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01428791, a NA study, has completed, sponsored by Rush University Medical Center.

COMPLETED
Registry status
NA
Development phase
250 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • BEHAVIORAL Generations older adult membership program
  • BEHAVIORAL BRIGHTEN Heart Virtual Team intervention

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2011-03
Est. Completion 2014-12-16
Phase NA
Rush University Medical Center

320 total trials

What the finished NCT01428791 record still lists

NCT01428791 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Generations older adult membership program is the first listed.

NCT01428791 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01428791 about?

NCT01428791 is a clinical study titled "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 ...

What is the current status of trial NCT01428791?

This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2011-03. Estimated completion is 2014-12-16.

What interventions are being tested in trial NCT01428791?

The interventions under investigation include: Generations older adult membership program (BEHAVIORAL), BRIGHTEN Heart Virtual Team intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT01428791?

This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01428791's enrollment target sits among peer trials

250 410th of 2000 higher than 1,567 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01428791, the US trial registry maintained by the National Library of Medicine. NCT01428791 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.