Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-26 @ 6:25 PM
Study NCT ID:
NCT00005157
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech Characteristics in Coronary Heart Disease
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To improve the predictive validity of Structured Interview assessments of Type A behavior by comparing interviewer techniques in the Multiple Risk Factor Intervention Trial (MRFIT) and the Western Collaborative Group Study (WCGS). To assess whether there were interviewer differences in the predictiveness of Type A behavior and its components for coronary heart disease incidence in MRFIT and WCGS and if so, to assess whether the interviewer differences in disease predictiveness were related to interviewer stylistics.
Detailed Description:
BACKGROUND:
Individuals with Type A behavior are characterized as hard driving, competitive, and time urgent; when asked questions they are quick to answer with emphatic speech; they perceive themselves to be striving and competing and are prone to hostility. This core of behaviors is presumed to be on a continuum of intensity with well-developed Type A's at the upper end and well-developed Type B's at the lower end. Epidemiological studies have shown Type A's to have a higher prevalence and incidence of various forms of coronary heart disease than Type B's. The Structured Interview is a method of measuring Type A behavior in which a series of questions are administered about the individual's characteristic responses to situations relevant to the Type A behavior pattern, such as reaction to delay and reported frequency of anger. The Interview is delivered in challenging style designed to elicit Type A characteristics.
In 1960, the WCGS recruited 3,154 employed men, ages 39 to 59, who were initially free of coronary heart disease and followed them for 8.5 years for coronary heart disease incidence. In 1972 MRFIT began recruiting 12,866 men, ages 35 to 57, selected for elevation of one or more risk factors, but free from coronary heart disease and followed them for an average of seven years after randomization to a risk factor modification group or to a control group referred to their own physicians for treatment. Both studies used the Structured Interview to assess Type A behavior.
In 1981, Type A behavior was officially regarded as an independent risk factor for coronary heart disease, based largely on the findings of the WCGS. However, the MRFIT did not find Type A behavior to be related to coronary heart disease incidence. The manner of conducting the Structured Interview may have affected the predictive reliability of the Type A assessments.
DESIGN NARRATIVE:
Interviewer speech characteristics from the WCGS and MRFIT Structured Interview tape recordings were audited and analyzed. Each speech characteristic was scored with high reliability. Multiple logistic regression analyses were used to control for standard risk factors.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Individuals with Type A behavior are characterized as hard driving, competitive, and time urgent; when asked questions they are quick to answer with emphatic speech; they perceive themselves to be striving and competing and are prone to hostility. This core of behaviors is presumed to be on a continuum of intensity with well-developed Type A's at the upper end and well-developed Type B's at the lower end. Epidemiological studies have shown Type A's to have a higher prevalence and incidence of various forms of coronary heart disease than Type B's. The Structured Interview is a method of measuring Type A behavior in which a series of questions are administered about the individual's characteristic responses to situations relevant to the Type A behavior pattern, such as reaction to delay and reported frequency of anger. The Interview is delivered in challenging style designed to elicit Type A characteristics.
In 1960, the WCGS recruited 3,154 employed men, ages 39 to 59, who were initially free of coronary heart disease and followed them for 8.5 years for coronary heart disease incidence. In 1972 MRFIT began recruiting 12,866 men, ages 35 to 57, selected for elevation of one or more risk factors, but free from coronary heart disease and followed them for an average of seven years after randomization to a risk factor modification group or to a control group referred to their own physicians for treatment. Both studies used the Structured Interview to assess Type A behavior.
In 1981, Type A behavior was officially regarded as an independent risk factor for coronary heart disease, based largely on the findings of the WCGS. However, the MRFIT did not find Type A behavior to be related to coronary heart disease incidence. The manner of conducting the Structured Interview may have affected the predictive reliability of the Type A assessments.
DESIGN NARRATIVE:
Interviewer speech characteristics from the WCGS and MRFIT Structured Interview tape recordings were audited and analyzed. Each speech characteristic was scored with high reliability. Multiple logistic regression analyses were used to control for standard risk factors.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL033737 | NIH | None | https://reporter.nih.gov/quic… | View |