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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858829
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tuğba Atan, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Psychometric analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fear of movement scale Other: Psychometric analysis
Psychometric analysis




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tuğba Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT03858829    
Other Study ID Numbers: 25901600/893
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuğba Atan, Hitit University:
coronary artery disease
physical activity
cardiac rehabilitation
validation studies
psychometrics
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases