Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480006
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Validity and Reliability of the BETY-Biopsychosocial Scale in Individuals With Coronary Artery Disease
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Evaluation of the Validity and Reliability of the BETY-Biopsychosocial Scale in Individuals With Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Scales for biopsychosocial assessment of coronary artery disease patients are limited The aim of this study was to evaluate the validity and reliability of the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire bETY-BQ in patients with CAD
Detailed Description:
Ischaemic heart disease also called coronary heart disease CHD is associated with obstruction of epicardial coronary arteries and inadequate blood supply to the myocardium usually caused by atherosclerosis which may result in the development of obstructive plaque called atheroma Imbalance in lipid accumulation and chronic inflammation of the vessel wall are considered to be the main causes of atherosclerosis Multiple pathophysiological mechanisms can cause CAD The most common atherosclerotic epicardial coronary artery occlusion is the most common However one third of patients may not have significant epicardial disease and often have microvascular disease as the underlying pathophysiology The Cognitive Exercise Therapy Approach BETY is an exercise-based biopsychosocial approach that has been ongoing for 14 years in which individuals of all ages with various rheumatic diseases participate in group exercises three days a week A biopsychosocial scale called BETY-Biopsychosocial Questionnaire BETY-BQ was created in line with the feedback received from patients who participated in this group for many years and the changes that occurred in them The patients mentioned that the existing scales did not measure the changes that occurred in them as a result of their participation in the BETY group for many years As a result the answers given by the patients to the question So what changes have you experienced were collected Reverse expressions of these sentences were created and the scale item pool was formed by determining the complaints when they did not receive treatment expert opinions were taken and the validity of the scale was finalised with rheumatic patients BETY-BQ includes items that provide information about pain sociability mood sexuality functionality and sleep quality
Demographic characteristics and clinical information were recorded Participants age diagnosis gender education level occupation marital status body weight height body mass index background family history monthly income level lifestyle characteristics smoking exercise habits will be recorded In addition clinical history of CAD number of daily medications and drug groups and additional chronic diseases will be questioned
Cardiovascular Disease Risk Scoring SCORE2 The SCORE risk scoring was developed by analysing data from studies in 12 European countries with more than 200000 participants approximately 3 million annual follow-ups and more than 7000 cardiovascular deaths In the SCORE table which has a high applicability in primary care 10-year CVD event risk is determined by using age gender total cholesterol smoking status and blood pressure values All atherosclerotic deaths not only deaths due to CAD are taken into account in the risk calculation and stroke-related deaths can be separated from CAD-related deaths when desired Studies in the SCORE database have shown that HDL-cholesterol may have a significant effect on risk calculation When HDL-cholesterol values are included in the SCORE tables it is seen that the risk changes at all risk levels at all ages and genders The updated SCORE algorithm SCORE2 incorporates the effect of the non-HDL-cholesterol value and estimates an individuals 10-year risk of fatal and non-fatal CVD events myocardial infarction stroke in apparently healthy people aged 40-69 years with risk factors SCORE2 and SCORE2-OP are calibrated according to four country clusters low intermediate high and very high CVD risk grouped according to national CVD mortality rates published by WHO Turkey is in the group of high-risk countries The risk calculated according to the SCORE system is considered low risk if 1 medium risk if 1-4 high risk if 5-9 and very high risk if 10 and above According to the SCORE2 system those under the age of 50 are considered to be at low-moderate risk if 25 high risk if 25-75 and very high risk if 75 and above In those over 50 years of age 5 is considered low-moderate risk 5-10 is considered high risk and 10 and above is considered very high risk
Quality of life assessment Short Form-36 Short Form-36 SF-36 will be used The scale consists of 36 items which are grouped into 8 subscales physical function 10 items role limitations related to physical function 4 items role limitations related to emotional problems 3 items energyvitality 4 items mental health 5 items social function 2 items pain 2 items and general health perception 5 items The assessment covers the last 4 weeks Each subgroup is scored within itself Scoring is in the range of 0-100 and the higher the score the better the quality of life In addition 2 summary scales physical component scale PCS and mental component scale MCS can be made The physical component scale consists of physical function role limitations related to physical functions pain and general health perception subgroups while the mental component scale consists of role limitations related to emotional problems energyvitality mental health and social function subgroups
Assessment of anxiety and depression The Hospital Anxiety and Depression Scale HADS was developed by Zigmond and Snaith 1983 The scale consists of 14 items Seven of these items measure anxiety and the other seven items measure depression symptoms The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3 According to the scoring 0-1 is considered as not ill 2 as borderline ill and 2-3 as severely ill It is also observed that the scores obtained from the scale are not affected by physical diseases The aim of the scale is not to make a diagnosis but to measure the psychological state of the patients and to take necessary precautions Turkish adaptation study and validity and reliability analyses were performed by Aydemir et al The HADS scale was also applied to patients without any physical disease but it was found to give more sensitive results in patient groups
Assessment of Biopsychosocial Characteristics Cognitive Exercise Therapy Approach- Biopsychosocial Scale BETY-BQ will be used to evaluate individuals in terms of biopsychosocial aspects The scale was developed by Ünal et al The scale has sub-dimensions that determine the biopsychosocial characteristics of individuals It includes pain functionality mood sociability sexuality and sleep parameters BETY-BQ is a 5-point Likert-type scale consisting of 30 items in total When the items of the scale are examined in detail items 12345 define the Pain sub-dimension items 67891011122628 define the Functionality sub-dimension items 131415161617181819202122 define the Emotional State sub-dimension items 232425 define the Sociability sub-dimension items 2729 define the Sexuality sub-dimension and item 30 defines the Sleep sub-dimension It offers a measurement between 0-120 values as scoring The sub-dimensions score range is Pain 0-20 Functionality 0-36 Emotional State 0-40 Sociability 0-12 Sexuality 0-8 Sleep 0-4 It gives the opportunity to evaluate individuals with both sub-dimensions and total score High scores indicate low quality of life and poor biopsychosocial status
Kinesiophobia Assessment Patients kinesiophobia will be assessed with the Turkish version of the Tampa Kinesiophobia Rating for the Heart KTKD a valid and reliable scale developed for cardiac diseases The KTKD assesses the subjective evaluation of kinesiophobia in relation to cardiac conditions These statements are made on a four-point Likert scale ranging from strongly disagree score 1 to strongly agree score 4 The scale consists of four subgroups including exercise avoidance fear of injury perceived danger of cardiac problems and dysfunction The 11-question Turkish version of the scale has been shown to be valid and reliable in patients with heart failure and PH and written permission was obtained for its use in this study
Assessment of Disease Specific Quality of Life It will be evaluated with the Seattle Angina Questionnaire SAQ SAQ is a disease-specific scale developed to evaluate functional capacity in patients with angina SAQ has five subscales physical function angina stability angina frequency treatment satisfaction and perception of quality of life It consists of 19 items Each item is answered using a 5 or 6-point Likert scale Each subscale is scored from 0 worst health status to 100 best health status
Demographic characteristics and clinical information were recorded Participants age diagnosis gender education level occupation marital status body weight height body mass index background family history monthly income level lifestyle characteristics smoking exercise habits will be recorded In addition clinical history of CAD number of daily medications and drug groups and additional chronic diseases will be questioned
Cardiovascular Disease Risk Scoring SCORE2 The SCORE risk scoring was developed by analysing data from studies in 12 European countries with more than 200000 participants approximately 3 million annual follow-ups and more than 7000 cardiovascular deaths In the SCORE table which has a high applicability in primary care 10-year CVD event risk is determined by using age gender total cholesterol smoking status and blood pressure values All atherosclerotic deaths not only deaths due to CAD are taken into account in the risk calculation and stroke-related deaths can be separated from CAD-related deaths when desired Studies in the SCORE database have shown that HDL-cholesterol may have a significant effect on risk calculation When HDL-cholesterol values are included in the SCORE tables it is seen that the risk changes at all risk levels at all ages and genders The updated SCORE algorithm SCORE2 incorporates the effect of the non-HDL-cholesterol value and estimates an individuals 10-year risk of fatal and non-fatal CVD events myocardial infarction stroke in apparently healthy people aged 40-69 years with risk factors SCORE2 and SCORE2-OP are calibrated according to four country clusters low intermediate high and very high CVD risk grouped according to national CVD mortality rates published by WHO Turkey is in the group of high-risk countries The risk calculated according to the SCORE system is considered low risk if 1 medium risk if 1-4 high risk if 5-9 and very high risk if 10 and above According to the SCORE2 system those under the age of 50 are considered to be at low-moderate risk if 25 high risk if 25-75 and very high risk if 75 and above In those over 50 years of age 5 is considered low-moderate risk 5-10 is considered high risk and 10 and above is considered very high risk
Quality of life assessment Short Form-36 Short Form-36 SF-36 will be used The scale consists of 36 items which are grouped into 8 subscales physical function 10 items role limitations related to physical function 4 items role limitations related to emotional problems 3 items energyvitality 4 items mental health 5 items social function 2 items pain 2 items and general health perception 5 items The assessment covers the last 4 weeks Each subgroup is scored within itself Scoring is in the range of 0-100 and the higher the score the better the quality of life In addition 2 summary scales physical component scale PCS and mental component scale MCS can be made The physical component scale consists of physical function role limitations related to physical functions pain and general health perception subgroups while the mental component scale consists of role limitations related to emotional problems energyvitality mental health and social function subgroups
Assessment of anxiety and depression The Hospital Anxiety and Depression Scale HADS was developed by Zigmond and Snaith 1983 The scale consists of 14 items Seven of these items measure anxiety and the other seven items measure depression symptoms The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3 According to the scoring 0-1 is considered as not ill 2 as borderline ill and 2-3 as severely ill It is also observed that the scores obtained from the scale are not affected by physical diseases The aim of the scale is not to make a diagnosis but to measure the psychological state of the patients and to take necessary precautions Turkish adaptation study and validity and reliability analyses were performed by Aydemir et al The HADS scale was also applied to patients without any physical disease but it was found to give more sensitive results in patient groups
Assessment of Biopsychosocial Characteristics Cognitive Exercise Therapy Approach- Biopsychosocial Scale BETY-BQ will be used to evaluate individuals in terms of biopsychosocial aspects The scale was developed by Ünal et al The scale has sub-dimensions that determine the biopsychosocial characteristics of individuals It includes pain functionality mood sociability sexuality and sleep parameters BETY-BQ is a 5-point Likert-type scale consisting of 30 items in total When the items of the scale are examined in detail items 12345 define the Pain sub-dimension items 67891011122628 define the Functionality sub-dimension items 131415161617181819202122 define the Emotional State sub-dimension items 232425 define the Sociability sub-dimension items 2729 define the Sexuality sub-dimension and item 30 defines the Sleep sub-dimension It offers a measurement between 0-120 values as scoring The sub-dimensions score range is Pain 0-20 Functionality 0-36 Emotional State 0-40 Sociability 0-12 Sexuality 0-8 Sleep 0-4 It gives the opportunity to evaluate individuals with both sub-dimensions and total score High scores indicate low quality of life and poor biopsychosocial status
Kinesiophobia Assessment Patients kinesiophobia will be assessed with the Turkish version of the Tampa Kinesiophobia Rating for the Heart KTKD a valid and reliable scale developed for cardiac diseases The KTKD assesses the subjective evaluation of kinesiophobia in relation to cardiac conditions These statements are made on a four-point Likert scale ranging from strongly disagree score 1 to strongly agree score 4 The scale consists of four subgroups including exercise avoidance fear of injury perceived danger of cardiac problems and dysfunction The 11-question Turkish version of the scale has been shown to be valid and reliable in patients with heart failure and PH and written permission was obtained for its use in this study
Assessment of Disease Specific Quality of Life It will be evaluated with the Seattle Angina Questionnaire SAQ SAQ is a disease-specific scale developed to evaluate functional capacity in patients with angina SAQ has five subscales physical function angina stability angina frequency treatment satisfaction and perception of quality of life It consists of 19 items Each item is answered using a 5 or 6-point Likert scale Each subscale is scored from 0 worst health status to 100 best health status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None