Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— Fact-CAD  

Official title:

Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease - (Fact-CAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858829
• Other study ID #: 25901600/893
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2019
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease.

Description:

Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease. A scale for Fear of ACTivity in patients with CAD (Fact-CAD) was created through semi-structured focus group interviews with patients. Face and content validity of Fact-CAD was verified. The scale was applied to 250 patients who had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months. Psychometric analysis included model fit, unidimensionality, reliability, local dependency, differential item functioning and external construct validity. Analyses were performed using the Rasch Analysis Model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject has had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months.

Exclusion Criteria:

• Acute cardiac event within the last month

• Attendance to cardiac rehabilitation

• Inability to read and understand,

• Inability to ambulate or unwillingness to participate

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Psychometric analysis
Psychometric analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A scale for fear of activity	Each item is scored by a 5-point likert scale (4= always, 3= mostly, 2= sometimes, 1= seldom, 0= never). The scale is bi-directional; seven items 1, 5, 9, 13, 17, 19 and 21 are positively designed and their scores are inversely scored (0= always, 1= mostly, 2= sometimes, 3= seldom, 4= never). Total score is calculated by summing the scores of each item. Higher scores indicate the severity of fear of activity.	baseline
Secondary	Nottingham Health Profile	It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life.	baseline
Secondary	Beck Depression Inventory	This is a 21-item self-report questionnaire evaluating the presence and severity of depressive symptoms in the vegetative, emotional, cognitive and motivational domains. Scores of each item ranges from 0 to 3, higher scores mean higher risk of depression.	baseline
Secondary	Beck Anxiety Inventory	Each item is rated on 4-point scale ranging from 0 to 3. Four items are related to anxiety mood, four items related to specific fears and fourteen items are related to physiological aspects of anxiety such as autonomic hyperactivity. Higher scores indicate higher levels of anxiety.	baseline