- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858829
Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease (Fact-CAD)
February 28, 2019 updated by: Tuğba Atan, Hitit University
Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease - (Fact-CAD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fear of movement scale
|
Psychometric analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
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.
|
baseline
|
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.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
February 27, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (Actual)
March 1, 2019
Study Record Updates
Last Update Posted (Actual)
March 4, 2019
Last Update Submitted That Met QC Criteria
February 28, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25901600/893
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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