Prospective Analysis of the Effect of Widowhood on CVD

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005424
• Other study ID #: 4342
• Secondary ID: R03HL049043
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: September 1993
• Est. completion date: February 1996

Study information

• Verified date: November 2001
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To determine the effect of widowhood on cardiovascular disease.

Description:

BACKGROUND:

Widowed persons have been found to have higher mortality rates than married persons in both cross-sectional and longitudinal studies. In many of these studies, excess mortality has been attributed to deaths from cardiovascular disease. Despite these consistent findings, the lack of detailed data collected prior to widowhood has hampered our ability to understand the mechanisms to explain this effect. Furthermore, an understanding of the mechanisms underlying this effect might help elucidate the apparent gender differences in mortality following widowhood.

DESIGN NARRATIVE:

The study took advantage of the data collected as part of the Framingham Study to investigate the effect of widowhood on cardiovascular disease. The Framingham dataset has extensive clinical data related to cardiovascular disease, as well as to health behaviors. These longitudinal data provided the opportunity to prospectively characterize the health of widows prior to and following the loss of a spouse in much greater detail than previously possible. The analyses used a prospective design in which those men and women who had a spouse die during the course of the study (N=626) were compared to men and women who remained married (N=2044). These analyses also provided the opportunity to examine reasons

for the beneficial effect found of remarriage. The study addressed the following questions:

1. Can the increased risk of mortality from cardiovascular disease often found following widowhood be explained by pre-widowhood health status? 2. Can increased mortality following widowhood be explained by changes in health behaviors related to cardiovascular disease risk. 3. What pre-widowhood risk factors place the widowed at greater risk for cardiovascular disease morbidity and/or mortality following the death of a spouse? 4. Can pre-widowhood risk factors or post-widowhood behavior change account for gender differences in mortality following widowhood?

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 1996
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)