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Clinical Trials/NCT07050303
NCT07050303CompletedNot Applicable

The Effect of a Mobile Application Based on the Social Cognitive Learning Theory on Medication Adherence and Hypertension Self-Efficacy in Patients With Hypertension: A Randomized Controlled Trial

Gozde Aygun1 site in 1 country86 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
1
Primary Endpoint
Medication Adherence Self-Efficacy Level in Hypertension Patients

Study Overview

Brief Summary

In this study, a mobile application designed based on the Social Cognitive Theory was evaluated in middle-aged individuals with hypertension:

H1(a): A mobile application based on the Social Cognitive Theory affects medication adherence self-efficacy levels in patients with hypertension.

H0(a): A mobile application based on the Social Cognitive Theory does not affect medication adherence self-efficacy levels in patients with hypertension.

H1(b): A mobile application based on the Social Cognitive Theory affects hypertension self-efficacy levels in patients with hypertension.

H0(b): A mobile application based on the Social Cognitive Theory does not affect hypertension self-efficacy levels in patients with hypertension.

H1(c): A mobile application based on the Social Cognitive Theory affects systolic and diastolic blood pressure levels in patients with hypertension.

H0(c): A mobile application based on the Social Cognitive Theory does not affect systolic and diastolic blood pressure levels in patients with hypertension.

Participants were asked to download and use the hypertension monitoring application designed by the researcher on their phones for a period of three months. A pre-test was administered through face-to-face interviews before installing the application. After using the application for three months, a post-test was conducted using the same scales through face-to-face interviews. For the control group, the same pre-test was administered through face-to-face interviews without using the application. After three months, a post-test was again conducted via face-to-face interviews.

The researchers compared the data of the participants with those of the control group.

Detailed Description

Non-communicable diseases (NCDs) account for two-thirds of all deaths globally. Hypertension, one of the NCDs, is a major risk factor for cardiovascular disability and death, affecting a high proportion of people worldwide. In Turkey, 1 in 3 people have hypertension, and it is more common in women than in men. Smartphone users have increased since 2007, and in 2019, an estimated 3.2 billion smartphone users, or about one-third of the global population, were reported. Mobile health (mHealth) technologies can be an effective way to promote hypertension self-management. Social Cognitive Learning Theory, developed by Bandura, focuses on behavioral change and the cognitive processes that influence behavior. Hypertension is a significant health problem in both developing and developed countries, and its increasing epidemic is a serious warning for more attention to this silent disease. Instead of routine and standard care interventions applied by nurses, adopting and implementing theory and model-based, scientifically supported care interventions will significantly contribute to the professionalization of the profession. When we look at the literature, it has been determined that mobile applications for hypertension patients in Turkey are limited or insufficient, and there is no mobile application based on social cognitive theory. We believe that this research will contribute to hypertension management through a mobile-based application. NCDs like hypertension are public health problems that place a heavy burden on healthcare systems and affect the entire society. This research is unique in this respect. The aim of this study is to examine the effectiveness of a mobile application on adherence to hypertension and medication treatment, and self-efficacy perception levels in hypertension patients. The study was designed as a two-group (pre-test - post-test) randomized controlled experimental design. The population of the study consists of patients aged 40-64 who applied to the Cardiology outpatient clinics of a university hospital in Aydın province within the last year (January 1 - December 31, 2024), diagnosed with hypertension, using antihypertensive drugs, and under follow-up (n=451). G-Power analysis (G Power 3.1.9.7) was used to determine the sample size. Based on the effect size of a similar study, it was determined that 82 participants should be included in the experimental and control groups, assuming a power of 0.80, an error level of 0.05, an effect size of 0.55, and a difference of 0.80. However, assuming potential losses from the sample group, 45 participants were included in the experimental group and 45 in the control group. Participants were selected through randomized control, and stratification by age and gender was performed between the two groups. Pre-test data were collected between september 25th and october 15th, 2024, and post-test data will be collected face-to-face by the researcher in the seminar hall of Aydın Adnan Menderes Application and Research Hospital between February 1, 2025, and March 30, 2025. Socio-demographic form, Short Form of Medication Adherence Self-Efficacy Scale, and Hypertension Self-Efficacy Scale will be used as data collection tools. Measurable data, such as blood pressure, height-weight, and body mass index, will be measured and recorded by the researcher. The mobile application developed by the researcher according to the Social Cognitive Theory will be applied to the experimental group. The content of the mobile application includes sub-headings such as definition and management of high blood pressure, medication use and adherence, high blood pressure and active lifestyle, high blood pressure and healthy eating, high blood pressure and stress management, high blood pressure and weight management, and the effect of smoking and alcohol consumption on high blood pressure. The follow-up period for the experimental group is set at 3 months. The control group will continue with routine care and follow-up at the hospital. Upon completion of the study, the Hypertension Self-Efficacy Scale and Medication Adherence Self-Efficacy Scale will be administered to the experimental and control groups, and measurable data will be re-recorded. When the study is completed, the mobile application will also be introduced and made available to participants in the control group if they wish. The collected data will be evaluated using SPSS 21.0 software in a computer environment. In all statistical analyses, p<0.05 will be considered statistically significant. With the developed mobile application, the additional burden and cost of the disease on the healthcare system and healthcare professionals can be reduced, and potential complications that may arise from the disease can be prevented.

Non-communicable diseases (NCDs) account for two-thirds of all deaths globally. In 2012, it was estimated that 67% of the 56 million deaths worldwide were due to non-communicable diseases (NCDs), particularly cardiovascular diseases (42.6%), cancers (21.7%), and chronic respiratory diseases (Hyder, 2017). Hypertension (HTN) is a cardiovascular syndrome characterized by a sustained elevation of arterial blood pressure, serving as one of the major risk factors for cardiovascular diseases and a leading cause of death. Hypertension is the most important risk factor for cardiovascular disability and mortality, affecting a high proportion of people worldwide (Zhang, 2021). Hypertension is considered a significant public health problem in both developed and developing countries. Hypertension prevalence rates are 36.5% in America, 36.9% in Lebanon, 34% in Australia, and 32% in Poland (Tailakh et al., 2013; Matar et al., 2015; Hering, 2018). In Turkey, 1 in 3 people have hypertension, and it is more common in women than in men (Turkish Society of Cardiology, 2022). Hypertension treatment involves various approaches, including non-pharmacological and pharmacological methods such as lifestyle modifications, physical activity, medical nutrition therapy, and medication therapy. Non-adherence to antihypertensive medication regimens is a major cause of inadequate blood pressure control. Up to 50% of failures in blood pressure control can be attributed to this non-adherence. Studies have shown that treatment of mild to moderate hypertension can reduce the risk of stroke by 30% to 43% and myocardial infarction by 15% (Yang, 2016). Sustainable Development Goals (SDGs) aim to reduce premature deaths from NCDs by one-third by 2030 (WHO, 2022). Kılıç and Türkoğlu (2021) determined in their studies that a large proportion of hypertension patients do not regularly attend their follow-ups, and nearly half do not regularly take their antihypertensive medications. Similarly, they reported that half of the patients stopped taking medication within the first year of diagnosis, and more than half stopped after approximately five years. A study mentioned that a lack of knowledge about hypertension is one of the most important reasons for ignoring high blood pressure in society. According to the results of a hypertension prevalence study conducted in Turkey in 2012, the blood pressure control rate in hypertensive patients receiving treatment was reported as 53.9%, and the reason for this was stated to be non-adherence to treatment (Kurt, 2020).

The World Health Organization recognizes the potential of digital health interventions to achieve universal health coverage and provide quality care for individuals through the use of mobile phones, web portals, or other digital tools (WHO, 2019). Smartphone users have increased since 2007, and in 2019, an estimated 3.2 billion smartphone users, or approximately one-third of the global population, were reported. With this increase, there has also been an increase in the number of health-related applications, and as of 2018, it was estimated that approximately 50% of 3.4 billion smartphone and tablet users had downloaded health-related applications (Choi et al., 2020).

As a subset of electronic health (eHealth), mobile health (mHealth) is defined as the use of mobile devices in the delivery of healthcare services, particularly through short message service (SMS) messaging, voice calls, mobile phone applications, tablets, or wearable device applications. The use of cost-effective innovative e-Health interventions such as mHealth can help improve the prevention and control of non-communicable diseases in disadvantaged populations (Saleh et al., 2018). Medication adherence is an important component of hypertension management; however, only half of all hypertensive patients are considered adherent to treatment. Forgetting to take medication is one of the most frequently reported reasons for non-adherence (Buis et al., 2017). Mobile health technologies can be an effective way to promote hypertension self-management. Mobile health applications, such as text message reminders, are thought to be a low-cost and effective way to improve medication adherence with wide accessibility (Buis et al., 2017). Tezcan (2016) reported that the expected effects of mobile health applications include creating more health-conscious individuals and healthier lifestyles, saving 30% of time spent by healthcare professionals on accessing and analyzing information, and reducing costs due to less need for hospitalizations.

Choi et al. (2020) investigated 12 studies published in Korean databases in their research titled "Mobile Application-Based Interventions for Patients with Hypertension and Ischemic Heart Disease: A Systematic Review." Of the seven studies that measured blood pressure in hypertensive patients, five found that application-based interventions reduced blood pressure, two of the three studies showed a significant decrease in body mass index in patients, and five of the seven studies reported a significant change in medication adherence. Buis et al. (2017) reported in their research titled "Text Messaging to Increase Adherence to Hypertension Medications from Primary Care and Emergency Department Settings in African Americans: Results of Two Randomized Feasibility Studies" that text message medication reminders could be effective in hypertension treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
41 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Research Inclusion Criteria:
  • •Diagnosed with hypertension (for at least 6 months).
  • •Currently using antihypertensive medication.
  • •Voluntarily agrees to participate in the research.
  • •Aged between 40-64 years (Turkish Society of Hypertension and Renal Diseases, 2012; TURKSTAT, 2022).
  • •No mental or communication-impairing issues.
  • •Not pregnant or a breastfeeding mother.
  • •Able to use a smartphone with an Android operating system.
  • •No additional comorbid diseases (e.g., cancer, diabetes mellitus).
  • •Has a semi-automatic upper-arm blood pressure monitor at home.

Exclusion Criteria

  • •Experiencing issues with internet access or mobile application usage.
  • •Voluntarily withdraws from the study during the research process.
  • •Uses an different operating system than Android operating system.

Arms & Interventions

Participitants

Experimental

Mobile application users

Intervention: Mobile Application Developed Based on Social Cognitive Theory (Other)

Control

No Intervention

non-users of application

Outcomes

Primary Outcomes

Medication Adherence Self-Efficacy Level in Hypertension Patients

Time Frame: From participation until the end-point is 3 months.

A mobile app can influence medication adherence self-efficacy levels in hypertension patients.

Hypertension Self-Efficacy Level in Hypertension Patients

Time Frame: From participation until the end-point is 3 months.

A mobile app influences hypertension self-efficacy levels in hypertension patients.

Secondary Outcomes

  • systolic and diastolic blood pressure(From participation until the end-point is 3 months.)

Investigators

Sponsor
Gozde Aygun
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Gozde Aygun

PhD

Muğla Sıtkı Koçman University

Study Sites (1)

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