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NCT01188070 · ClinicalTrials.gov registry record · NA

Caregiver Stress: Interventions to Promote Health and Wellbeing

A NA study of Health Promotion, sponsored by Emory University.

Completed
Registry status
NA
Development phase
354
Enrollment target
1
Study location

NCT01188070 is a NA study of Health Promotion that has completed, run by Emory University. The registered enrollment target is 354 participants, below the 8,943-participant average among 10 other Health Promotion trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01188070, a NA study of Health Promotion, has completed, sponsored by Emory University.

COMPLETED
Registry status
NA
Development phase
354 participants
Enrollment target
1
Study location

Study Summary

More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of heart disease. Identification of effective self-care interventions for family caregivers is warranted to improve their emotional wellbeing and minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with chronic illness. In two studies the investigators will test two interventions, psycho-education(ED) and physical exercise(EX), individually and in combination. The first study will target FCG of African American dementia patients; the second will focus on FCG of heart failure patients. Parallel designs, interventions and measures will create synergy as will integration of all data management and analyses within a Bio-behavioral Science and Measures Core. This Core will also provide high level guidance and interpretation of model testing resulting from analysis of the common data set. The combined de-identified data set will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk, further developing the model, and stimulating future research, while the shared core support will provide substantial efficiency; neither could be achieved outside of a Program Project approach. These collective efforts will generate important data whereby future care can significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the number one cause of disability and death in the United States. We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden and higher levels of flourishing), beha

Conditions Studied

Interventions

  • BEHAVIORAL Usual Care
  • BEHAVIORAL Psycho-education
  • BEHAVIORAL Psycho-education plus physical exercise

Study Locations (1)

Georgia

  • Emory Universtiy - Atlanta

Trial Details

FieldValue
Enrollment Target 354 participants
Start Date 2010-01
Est. Completion 2014-05
Phase NA

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT01188070

The ClinicalTrials.gov registry entry for NCT01188070 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,943-participant average among 10 other Health Promotion trials with a reported enrollment target (96% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Health Promotion appearing as the primary indexed condition, and to 3 interventions - of which Usual Care is the first listed.

NCT01188070 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT01188070 about?

NCT01188070 is a clinical study titled "Caregiver Stress: Interventions to Promote Health and Wellbeing". More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of he...

What is the current status of trial NCT01188070?

This trial is currently completed. It is a NA study. The enrollment target is 354 participants. The study started on 2010-01. Estimated completion is 2014-05.

What conditions does trial NCT01188070 study?

This clinical trial studies the following conditions: Health Promotion.

What interventions are being tested in trial NCT01188070?

The interventions under investigation include: Usual Care (BEHAVIORAL), Psycho-education (BEHAVIORAL), Psycho-education plus physical exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT01188070?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01188070 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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