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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03858829
Acronym
Fact-CAD
Enrollment
250
Registered
2019-03-01
Start date
2014-02-28
Completion date
2016-10-31
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, physical activity, cardiac rehabilitation, validation studies, psychometrics

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.

Interventions

OTHERPsychometric analysis

Psychometric analysis

Sponsors

Hitit University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
A scale for fear of activitybaselineEach 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

MeasureTime frameDescription
Nottingham Health ProfilebaselineIt 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 InventorybaselineThis 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 InventorybaselineEach 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026