Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06321159 |
| Other study ID # |
Nursing Dep. |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2024 |
| Est. completion date |
January 30, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Inonu University |
| Contact |
Fidan BALKAYA, PhD student |
| Phone |
+905454709480 |
| Email |
fidan.balkaya[@]inonu.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 47.9%
of participants received a hypertension diagnosis, and a significant 67.8% 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 project's 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 individuals' 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 140/90 mmHg or higher will be included based on expert
physician recommendations, with notifications for those exceeding 160/100 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.
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, i.e. 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 31.2% (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 1.19 points, quality of life by 4.45 to 14.62
points, and reduced systolic blood pressure by 8.68 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 8.26 (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 & Gözüm, 2011, Jones et al.,
2020; Ozemek et al., 2018; Ventura & 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 (3.75 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 trans/saturated/total 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 8.3 and 5.2
mm Hg, respectively (Cornelissen & 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 trans/saturated/total 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 8.3 and 5.2
mm Hg, respectively (Cornelissen & 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 & 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., 2017).In 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 & Paköz, 2020). In a study conducted in
our country, it was reported that 36.3% of patients complied with hypertension treatment
(Akan, Çaydam & 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 & Arbaycu, 2013). Incorrect and incomplete administration of treatment, dose
skipping, and discontinuation of treatment negatively affect treatment compliance. This
situation may lead to repeated hospital admissions, hospitalisation, prolonged recovery
process and increased financial burden (Bulut, 2006). As a matter of fact, treatment success
in hypertension, which is a chronic disease, is associated with the patient's
continuous adherence to treatment (Krousel-Wood M et all 2004). Education and follow-up
programmes applied to hypertension patients are important practices that ensure compliance
with treatment and increase the compliance of patients with lifestyle changes and drug
treatment. As a result, cardiovascular diseases and re-hospitalisation rates decrease (Irmak
et al. 2007). In addition, in the management of hypertension, the training given to patients
by nurses as well as physicians should be supported by technological-based applications such
as telephone counselling to increase compliance with drug treatment both in the hospital
environment and in the living area. As a matter of fact, it has been found that education and
telephone counselling given to hypertension patients are effective in drug treatment
compliance and rational drug use (Ayruk, 2022). The content of the education should be in a
way to increase treatment compliance such as regular and timely use of medication, continuing
to use medication even in case of some mild side effects, nutrition and exercise. Effective
practices to control blood pressure levels and improve the quality of life of hypertensive
patients should include a combination of appropriate health services, information,
counselling, reminder, self-monitoring, support and family therapy (Hacihasanoğlu and Gözüm
2011). As a matter of fact, education and telephone counselling given to hypertension
patients were found to be effective in drug treatment compliance and rational drug use
(Ayruk, 2022).In this project, it is planned to develop mobile software for hypertension
management. There are many mobile applications in the literature to increase compliance with
the so-called DASH diet (Table 1). In this context, in a study in which existing applications
were evaluated in terms of knowledge acquisition, skill development, behaviour change,
purpose, functionality and suitability for hypertensive adult individuals, it was revealed
that only two of the seven mobile applications were effective. None of the seven applications
included in the evaluation included an appropriate physical exercise intervention prepared by
the research team by evaluating the physical capacity of the patient (Alnooh et al., 2023).
In this software, exercise will be performed in accordance with the physical capacity of
individuals. In a systematic study conducted by Choi et al. (2020) to analyse mobile
application-based interventions for patients with hypertension and ischaemic heart disease,
it was reported that there were findings that mobile applications reduced the body mass index
of patients and lowered blood pressure, but the long-term effectiveness of these applications
was not tested (Choi et al., 2020). Thangada et al. (2018), in their study evaluating mobile
health applications developed for hypertensive and diabetic patients, showed that these
mobile applications are effective in managing blood pressure, but reported that applications
that provide in-app patient-consultant communication and provide feedback to the patient are
more advantageous in terms of effectiveness (Thangada et al., 2018). In this context, in our
study, in addition to the researchers, the participation of a specialist physician from each
region as a consultant constitutes the unique value of the study.
In the management of hypertension, individual effective lifestyle changes for each patient
can reduce the number and dose of drugs used for hypertension treatment and increase the
effect of antihypertensive drugs (Turkish Society of Cardiology National Hypertension
Treatment and Follow-up Guidelines, Choi et al., 2020). One of the factors that make the
project unique is that it involves a multidisciplinary team including physicians, nurses,
dieticians, physiotherapists in the provision of hypertension care services and is adapted to
meet individual-specific needs with a patient-centred approach. Health professionals support
primary health care activities by sharing the responsibilities of hypertension care including
medication management, active patient follow-up and medication compliance and self-management
support with the mobile application. With the mobile application, lifestyle changes such as
individual-specific diet and exercise, prevention of hypertension by increasing medication
compliance, and emergency department visits in hypertension-related complications can be
reduced (Phan et al., 2023).
