Back to resultsDevelopment and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease (Fact-CAD)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychometric analysis
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease focused on measuring coronary artery disease, physical activity, cardiac rehabilitation, validation studies, psychometrics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fear of movement scale
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03858829
Brief Title
Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease
Acronym
Fact-CAD
Official Title
Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease - (Fact-CAD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, physical activity, cardiac rehabilitation, validation studies, psychometrics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fear of movement scale
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Psychometric analysis
Intervention Description
Psychometric analysis
Primary Outcome Measure Information:
Title
A scale for fear of activity
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Nottingham Health Profile
Description
It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life.
Time Frame
baseline
Title
Beck Depression Inventory
Description
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.
Time Frame
baseline
Title
Beck Anxiety Inventory
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31562874
Citation
Ozyemisci-Taskiran O, Demirsoy N, Atan T, Yuksel S, Coskun O, Aytur YK, Tur BS, Karakas M, Turak O, Topal S. Development and Validation of a Scale to Measure Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD). Arch Phys Med Rehabil. 2020 Mar;101(3):479-486. doi: 10.1016/j.apmr.2019.09.001. Epub 2019 Sep 25.
Results Reference
derived
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Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease
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