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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Psychometric analysis

• Registration Number: NCT03858829
• Lead Sponsor: Hitit University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2019-02
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-28
• Study First Posted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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
• İnability to read and understand,
• İnability to ambulate or unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fear of movement scale	Psychometric analysis	-

Primary Outcome Measures

Name	Time	Method
A scale for fear of activity	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Nottingham Health Profile	baseline	It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life.
Beck Depression Inventory	baseline	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.
Beck Anxiety Inventory	baseline	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.