Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321159
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-14
Brief Title:
Investigation of the Effect of Mobile Software Use in Blood Pressure Management of Hypertensive Individuals on Quality of Life and Disease Self-Efficacy
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
Official Title:
Investigation of the Effect of the Use of Mobile Software in Blood Pressure Management on the Quality of Life and Disease Self-Efficacy of Hypertensive Individuals Sheltered in Temporary Living Area
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Hypertension is a prevalent health concern affecting one in three adults globally with the potential to lead to fatal complications However an alarming proportion of those diagnosed-four out of five individuals-struggle to effectively manage this condition As such the effective management of hypertension becomes paramount A study conducted post-earthquake by a principal investigator and a scholarship recipient revealed that 479 of participants received a hypertension diagnosis and a significant 678 ceased active management of the condition Existing literature suggests a notable decline in the quality of life among individuals unable to manage hypertension effectively While current research emphasizes the components of nutrition exercise and medication adherence in hypertension management the integration of these components into mobile applications is notably lacking This project seeks to enhance disease management for users by integrating crucial elements including blood pressure measurement into a user-friendly mobile application thereby providing a distinctive contribution The proposed application encompasses the recording of vital signs integration of customized diet and exercise programs tailored for hypertension and provision of consultancy services for identifying deviations in health status and implementing appropriate interventions The integration of these components is anticipated to contribute to preventing or minimizing potential complications for the patient Comprehensive studies incorporating such an approach are rarely encountered in the existing literature enhancing the originality of this research The projects overarching goal is to enable individuals to manage hypertension even in extraordinary circumstances such as earthquakes Consequently the study will assess how the mobile application influences individuals quality of life and disease self-efficacy
Conducted between April 2024 and January 2026 the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces It involves 614 individuals diagnosed with hypertension residing in temporary living space in Malatya Hatay Kahramanmaraş and Adıyaman with 78 77 and 74 participants in Malatya Hatay and Adıyaman respectively Data collection tools include the Personal Identification Information Form Hypertension Self-Efficacy Scale SF-36 Quality of Life Scale and International Physical Activity Scale-Short Form administered through face-to-face interviews The mobile application development will be a collaborative effort with two faculty members from the Department of Computer Engineering and expert academicians For the diet program within the application eight questions will be used to uncover individualsamp39 dietary preferences Calculations based on Body Mass Index basal metabolic rate and daily energy requirements will inform the diet program which will encompass five food groups and their caloric values Notifications about diet adherence will be sent for each meal In the exercise program individuals will measure and record blood pressure and medication intake Those with a blood pressure of 14090 mmHg or higher will be included based on expert physician recommendations with notifications for those exceeding 160100 mmHg to consult a physician A personalized exercise program will be created based on the OMRİ-RİS scale supported by animations Training videos for blood pressure measurements and medication adherence will be recorded and supervised by local academic nurse practitioners Data analysis will utilize appropriate statistical tests conducted through computer programs The project is anticipated to contribute significantly to researcher development enhance quality of life and disease management increase productivity and establish new projects
Conducted between April 2024 and January 2026 the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces It involves 614 individuals diagnosed with hypertension residing in temporary living space in Malatya Hatay Kahramanmaraş and Adıyaman with 78 77 and 74 participants in Malatya Hatay and Adıyaman respectively Data collection tools include the Personal Identification Information Form Hypertension Self-Efficacy Scale SF-36 Quality of Life Scale and International Physical Activity Scale-Short Form administered through face-to-face interviews The mobile application development will be a collaborative effort with two faculty members from the Department of Computer Engineering and expert academicians For the diet program within the application eight questions will be used to uncover individualsamp39 dietary preferences Calculations based on Body Mass Index basal metabolic rate and daily energy requirements will inform the diet program which will encompass five food groups and their caloric values Notifications about diet adherence will be sent for each meal In the exercise program individuals will measure and record blood pressure and medication intake Those with a blood pressure of 14090 mmHg or higher will be included based on expert physician recommendations with notifications for those exceeding 160100 mmHg to consult a physician A personalized exercise program will be created based on the OMRİ-RİS scale supported by animations Training videos for blood pressure measurements and medication adherence will be recorded and supervised by local academic nurse practitioners Data analysis will utilize appropriate statistical tests conducted through computer programs The project is anticipated to contribute significantly to researcher development enhance quality of life and disease management increase productivity and establish new projects
Detailed Description:
Hypertension HT is a chronic disease that is widespread in the population and can lead to serious complications Its high prevalence in Turkey and worldwide makes prevention and management of this disease critical HT is a systemic disease characterised by persistently high blood pressure and is an important public health problem because it causes serious complications and is widely prevalent in the community Hacıhasanoğlu Aşılar 2015 Obesity Dyslipidaemia Hypertension Working Group 2022 It is known that more than 30 of the adult population worldwide ie more than one billion people worldwide are affected by hypertension PAHO 2020 In our country according to the data of the Turkish Society of Cardiology the prevalence of hypertension in the adult population is 312 Turkish Society of Cardiology 2022 When hypertension is not well managed it is known to be one of the leading causes of death leading to stroke and heart attack Turkish Society of Cardiology 2022 Zhang et al 2021 and one of the most important risk factors for many chronic diseases such as diabetes and renal failure Mancia et al 2013 In a systematic review of the economic burden of cardiovascular disease and hypertension in low- and middle-income countries it was found that the expenditures for hypertension and cardiovascular diseases in countries vary between 500 and 1500 dollars and in countries such as Mexico China Brazil and India it constitutes half of health expenditures Gheorghe et al 2018 Considering its prevalence in the world and in Turkey and the high prevalence of material and moral damage it becomes clear how important it is to prevent and manage hypertension In recent studies it has been found that individuals diagnosed with hypertension have a worse quality of life compared to those who do not have this diagnosis Xu et al 2016 and interventions for hypertension treatment and compliance positively affect the quality of life of individuals Arija et al 2018 Li et al 2018 Souza et al 2016 Zhang et al 2021 Silva et al 2020 Emre et al 2020 2018 examined the effect of physical activity on cardiovascular health quality of life and blood pressure and found that physical activity increased the risk of cardiovascular disease by 119 points quality of life by 445 to 1462 points and reduced systolic blood pressure by 868 mm Hg In the meta-analysis study conducted by Souza and colleagues it was found that training on hypertension management increased quality of life scores by an average of 826 Souza et al 2016 It has been reported that interventions for hypertension treatment and compliance positively affect the quality of life of individuals Arija et al 2018 Li et al 2018 Souza et al 2016 Zhang et al 2021 Silva et al 2020 Emre et al 2020 Recent studies have addressed different aspects of hypertension such as quality of life diet exercise and economic burden However it was observed that technology was not integrated in the management of hypertension in these studies
It is seen that lifestyle changes such as nutrition and exercise are effective in both prevention and management of hypertension Hacıhasanoğlu ampamp Gözüm 2011 Jones et al 2020 Ozemek et al 2018 Ventura ampamp Lavia 2018 Although excessive sodium intake among dietary factors predisposes individuals to the development of hypertension dietary interventions for sodium restriction are still considered a popular recommendation for lowering blood pressure Lackland et al 2007 Whelton et al 2018 World Health Organization 2012 The Dietary Approaches to Stop Hypertension DASH diet and the Mediterranean diet are examples of effective dietary interventions to lower blood pressure based on healthy eating strategies The DASH diet is a dietary model that emphasises the consumption of whole grain foods legumes oilseeds fish and poultry fruits vegetables and low-fat dairy products while restricting the consumption of red meat high-fat and sugary foods and beverages On the other hand in this diet model it was emphasised that the daily sodium intake of hypertensive individuals should be below 1500 mg 375 g salt in order to reduce blood pressure Filippou et al 2020 In addition it is seen that the content of the DASH diet is consistent with the nutritional recommendations of the World Health Organization the American Heart Association and the Turkish Society of Hypertension and Kidney Diseases which are effective in lowering blood pressure In the meta-analysis study conducted by Schwingshackl et al 2019 it was revealed that the DASH diet reduced systolic blood pressure by 90 and diastolic blood pressure by 91 In addition to reducing sodium intake healthy dietary patterns with high potassium calcium magnesium and fibre content and low transsaturatedtotal fat and dietary cholesterol content can also be considered as beneficial components of blood pressure Indeed recent findings have shown that the combination of low sodium and a healthy diet can lower blood pressure by approximately 50 more than low sodium intake alone Filippou et al 2022 In the literature there are studies revealing that exercise has an effect on hypertension as well as dietary practices It is seen that these exercises mostly consist of aerobic resistance and combined exercise applications Lopes et al 2018 Pescatello 2019 Regular aerobic exercise has been found to help reduce systolic and diastolic blood pressure by 83 and 52 mm Hg respectively Cornelissen ampamp Smart 2013 Aerobic exercise has also been found to have positive effects on pulse wave velocity which is used as the gold standard in determining arterial stiffness Zhang et al 2018 In addition it is seen that the content of the DASH diet is consistent with the nutritional recommendations of the World Health Organization the American Heart Association and the Turkish Society of Hypertension and Kidney Diseases which are effective in lowering blood pressure In the meta-analysis study conducted by Schwingshackl et al 2019 it was revealed that the DASH diet reduced systolic blood pressure by 90 and diastolic blood pressure by 91 In addition to reducing sodium intake healthy dietary patterns with high potassium calcium magnesium and fibre content and low transsaturatedtotal fat and dietary cholesterol content can also be considered as beneficial components of blood pressure Indeed recent findings have shown that the combination of low sodium and a healthy diet can lower blood pressure by approximately 50 more than low sodium intake alone Filippou et al 2022 In the literature there are studies revealing that exercise has an effect on hypertension as well as dietary practices It is seen that these exercises mostly consist of aerobic resistance and combined exercise applications Lopes et al 2018 Pescatello 2019 Regular aerobic exercise has been found to help reduce systolic and diastolic blood pressure by 83 and 52 mm Hg respectively Cornelissen ampamp Smart 2013 Aerobic exercise has also been found to have positive effects on pulse wave velocity which is used as the gold standard in determining arterial stiffness Zhang et al 2018 Dynamic resistance exercises are also frequently performed in hypertensive individuals The rationale for this is that during dynamic RE blood flow is restricted during the contraction phase but increases during the relaxation phase resulting in more O2 delivery and oxidative metabolism Williams et al 2018 It is stated that there are positive effects on systolic and diastolic blood pressure after the application of resistance exercises with resistance tyres Henkin et al 2023 The use of resistance bands offers the opportunity for extremely safe and objective exercise practice The intensity of the exercise can be determined by determining the degree of difficulty perceived by the practitioner Therapeutic effect can be seen in hypertensive individuals with resistance exercises to be applied to major muscle groups It has been stated that diaphragmatic breathing technique inhibits sympathetic nerve activities and chemoreflex activation by activating pulmonary-cardiac mechanoreceptors and thus helps arteriolar dilatation Wang et al 2010 Yau ampamp Loke 2021 As a result of increased parasympathetic activity and baroreflex sensitivity a decrease in systolic and diastolic blood pressure is observed in hypertensive adults Mourya et al 2009 Voluntary diaphragmatic deep breathing is known to have a relaxing effect and reduce anxiety in hypertensive or prehypertensive individuals other than systolic and diastolic blood pressures Chen et al 2017In the planned project exercises which are thought to be effective in disease management will be created in line with the preferences of the individual and the recommendations of the physiotherapist age gender BMI etc and a notification will be sent when the exercise programme is created In this way the body mass index will remain within normal limits as the individual exercises regularly and disease management will be ensured
In the management of hypertension treatment compliance is also an important factor that ensures blood pressure control As a matter of fact the rate of blood pressure control in the world and in our country is around 25 and the most important factor in this is non-compliance with treatment Akan Çaydam ampamp Paköz 2020 In a study conducted in our country it was reported that 363 of patients complied with hypertension treatment Akan Çaydam ampamp Paköz 2020 Some of the factors that negatively affect treatment compliance are that the time allocated by the physician to the patient is not sufficient in public hospitals where the patient density is too high and the physician-patient communication is not at the desired level especially for individuals with chronic diseases such as diabetes hypertension and heart diseases Atıcı 2007 Significant problems that threaten patient safety may arise from lack of communication between the patient and the physician When these patients are informed and included in the decision-making process they are more careful about behavioural changes such as adherence to treatment diet exercise Factors such as not informing the patient about the diet to be applied during the discharge process not explaining how to use the prescribed prescription the physician not allocating time for informing the patient or not having time for informing the patient and not having a suitable environment for informing in the ward negatively affect treatment compliance Bol Gül ampamp Arbaycu 2013
It is seen that lifestyle changes such as nutrition and exercise are effective in both prevention and management of hypertension Hacıhasanoğlu ampamp Gözüm 2011 Jones et al 2020 Ozemek et al 2018 Ventura ampamp Lavia 2018 Although excessive sodium intake among dietary factors predisposes individuals to the development of hypertension dietary interventions for sodium restriction are still considered a popular recommendation for lowering blood pressure Lackland et al 2007 Whelton et al 2018 World Health Organization 2012 The Dietary Approaches to Stop Hypertension DASH diet and the Mediterranean diet are examples of effective dietary interventions to lower blood pressure based on healthy eating strategies The DASH diet is a dietary model that emphasises the consumption of whole grain foods legumes oilseeds fish and poultry fruits vegetables and low-fat dairy products while restricting the consumption of red meat high-fat and sugary foods and beverages On the other hand in this diet model it was emphasised that the daily sodium intake of hypertensive individuals should be below 1500 mg 375 g salt in order to reduce blood pressure Filippou et al 2020 In addition it is seen that the content of the DASH diet is consistent with the nutritional recommendations of the World Health Organization the American Heart Association and the Turkish Society of Hypertension and Kidney Diseases which are effective in lowering blood pressure In the meta-analysis study conducted by Schwingshackl et al 2019 it was revealed that the DASH diet reduced systolic blood pressure by 90 and diastolic blood pressure by 91 In addition to reducing sodium intake healthy dietary patterns with high potassium calcium magnesium and fibre content and low transsaturatedtotal fat and dietary cholesterol content can also be considered as beneficial components of blood pressure Indeed recent findings have shown that the combination of low sodium and a healthy diet can lower blood pressure by approximately 50 more than low sodium intake alone Filippou et al 2022 In the literature there are studies revealing that exercise has an effect on hypertension as well as dietary practices It is seen that these exercises mostly consist of aerobic resistance and combined exercise applications Lopes et al 2018 Pescatello 2019 Regular aerobic exercise has been found to help reduce systolic and diastolic blood pressure by 83 and 52 mm Hg respectively Cornelissen ampamp Smart 2013 Aerobic exercise has also been found to have positive effects on pulse wave velocity which is used as the gold standard in determining arterial stiffness Zhang et al 2018 In addition it is seen that the content of the DASH diet is consistent with the nutritional recommendations of the World Health Organization the American Heart Association and the Turkish Society of Hypertension and Kidney Diseases which are effective in lowering blood pressure In the meta-analysis study conducted by Schwingshackl et al 2019 it was revealed that the DASH diet reduced systolic blood pressure by 90 and diastolic blood pressure by 91 In addition to reducing sodium intake healthy dietary patterns with high potassium calcium magnesium and fibre content and low transsaturatedtotal fat and dietary cholesterol content can also be considered as beneficial components of blood pressure Indeed recent findings have shown that the combination of low sodium and a healthy diet can lower blood pressure by approximately 50 more than low sodium intake alone Filippou et al 2022 In the literature there are studies revealing that exercise has an effect on hypertension as well as dietary practices It is seen that these exercises mostly consist of aerobic resistance and combined exercise applications Lopes et al 2018 Pescatello 2019 Regular aerobic exercise has been found to help reduce systolic and diastolic blood pressure by 83 and 52 mm Hg respectively Cornelissen ampamp Smart 2013 Aerobic exercise has also been found to have positive effects on pulse wave velocity which is used as the gold standard in determining arterial stiffness Zhang et al 2018 Dynamic resistance exercises are also frequently performed in hypertensive individuals The rationale for this is that during dynamic RE blood flow is restricted during the contraction phase but increases during the relaxation phase resulting in more O2 delivery and oxidative metabolism Williams et al 2018 It is stated that there are positive effects on systolic and diastolic blood pressure after the application of resistance exercises with resistance tyres Henkin et al 2023 The use of resistance bands offers the opportunity for extremely safe and objective exercise practice The intensity of the exercise can be determined by determining the degree of difficulty perceived by the practitioner Therapeutic effect can be seen in hypertensive individuals with resistance exercises to be applied to major muscle groups It has been stated that diaphragmatic breathing technique inhibits sympathetic nerve activities and chemoreflex activation by activating pulmonary-cardiac mechanoreceptors and thus helps arteriolar dilatation Wang et al 2010 Yau ampamp Loke 2021 As a result of increased parasympathetic activity and baroreflex sensitivity a decrease in systolic and diastolic blood pressure is observed in hypertensive adults Mourya et al 2009 Voluntary diaphragmatic deep breathing is known to have a relaxing effect and reduce anxiety in hypertensive or prehypertensive individuals other than systolic and diastolic blood pressures Chen et al 2017In the planned project exercises which are thought to be effective in disease management will be created in line with the preferences of the individual and the recommendations of the physiotherapist age gender BMI etc and a notification will be sent when the exercise programme is created In this way the body mass index will remain within normal limits as the individual exercises regularly and disease management will be ensured
In the management of hypertension treatment compliance is also an important factor that ensures blood pressure control As a matter of fact the rate of blood pressure control in the world and in our country is around 25 and the most important factor in this is non-compliance with treatment Akan Çaydam ampamp Paköz 2020 In a study conducted in our country it was reported that 363 of patients complied with hypertension treatment Akan Çaydam ampamp Paköz 2020 Some of the factors that negatively affect treatment compliance are that the time allocated by the physician to the patient is not sufficient in public hospitals where the patient density is too high and the physician-patient communication is not at the desired level especially for individuals with chronic diseases such as diabetes hypertension and heart diseases Atıcı 2007 Significant problems that threaten patient safety may arise from lack of communication between the patient and the physician When these patients are informed and included in the decision-making process they are more careful about behavioural changes such as adherence to treatment diet exercise Factors such as not informing the patient about the diet to be applied during the discharge process not explaining how to use the prescribed prescription the physician not allocating time for informing the patient or not having time for informing the patient and not having a suitable environment for informing in the ward negatively affect treatment compliance Bol Gül ampamp Arbaycu 2013
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