Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease (Fact-CAD)
|ClinicalTrials.gov Identifier: NCT03858829|
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 4, 2019
Information provided by (Responsible Party):
Tuğba Atan, Hitit University
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Other: Psychometric analysis||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease - (Fact-CAD)|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||October 2016|
|Experimental: fear of movement scale||
Other: Psychometric analysis
Primary Outcome Measures :
- A scale for fear of activity [ Time Frame: 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 :
- Nottingham Health Profile [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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