Clinical trial NCT05995977: The Effect of Nursing Interventions Based on Conservation Motivation Theory on Drug Adherence and Healthy Lifestyle Behaviors in Patients With Hypertension: A Randomized Controlled Study
Official title: The Effect of Nursing Interventions Based on Conservation Motivation Theory on Drug Adherence and Healthy Lifestyle Behaviors in Patients With Hypertension: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension, Public Health; Nursing Staff
Keywords: Hypertension, Nursing Staff, Medication Adherence, Healthy lifestyles
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: APPLICATION The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on CMT. The second component is the sending of regularly delivered KMT-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes.

Applications made to the intervention group:

NURSING INITIATIVES (HYPERNI)

1. Hypertension Education:
2. Sending an SMS Message:

Applications to the control group: No intervention will be applied to the control group by the researcher during the study. Upon the collection of the follow-up test data of the control group, information notes and brochures created within the scope of the research will be given to the patients who request it from this group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although hypertension is an important cause of premature death, it can increase the risk of heart, brain, kidney and other diseases. Worldwide, 1 in 4 men and 1 in 5 women (over a billion people) have this condition (https://www.who.int/health-topics/hypertension#tab=tab_1 4 July 2022). The prevalence of hypertension in Turkey was determined as 32.3% in women, 28.4% in men and 30.3% in general, according to the Turkish Hypertension Prevalence (PatenT2) study (Sengul et al. 2016). Although the exact cause of hypertension is not clear, age, family history, eating habits, smoking-alcohol intake, weight and physical activity level have a strong influence on blood pressure. Hypertension management is normally easy through regular use of antihypertensive drugs and adherence to lifestyle interventions (https://world-heart-federation.org/what-we-do/hypertension/ 4 July 2022). As a matter of fact, it is stated in the World Health Organization (WHO) hypertension guideline that healthy lifestyle behaviors should be considered together with antihypertensive drugs (WHO 2021). The recommended healthy lifestyle behaviors for the prevention and control of hypertension are reducing salt consumption, high potassium intake, healthy diet, fighting obesity, regular physical activity and reducing cigarette-alcohol consumption (Mills et al. 2020).

Despite the availability and high prevalence of treatment for hypertension, less than 1 in 5 people worldwide have it under control (https://www.who.int/news-room/fact-sheets/detail/hypertension 4 July 2022). In Turkey, an estimated 49.1% of adults with hypertension are unaware that they have this condition. However, less than half (46.2%) of adults with hypertension are treated and approximately 1 in 5 adults (23.9%) have it under control(https://www.who.int/publications/m/item/hypertension-tur-country-profile-turkey-2020 4 July 2022) . Although the nutritional, behavioral, and environmental causes of hypertension are well established, little is known about what actions and interventions are responsible for the low rates of awareness, treatment, and control (Zhou et al. 2021).

Therefore, the development of new approaches to improve the prevention, management and control of hypertension has come to the fore(Özpulat 2017; Karmakar et al. 2018). The Turkish Hypertension Consensus report recommended that "tele-medicine" applications should be started to be used for blood pressure control and drug compliance with the advancing technology (https://fka.gov.tr/kalkinma-planlari-detayi-1564726568912 17 August 2022). Hypertension management guideline published by the Japanese Hypertension Society (JSH)-2019 explains that digital hypertension management can be facilitated using health information technology (Kario 2019). According to the International Council of Nurses (ICN), team-based care (especially virtual care) empowered through technology can respond to the change sought in healthcare delivery (ICN 2021). Likewise, WHO stated that using mobile health technologies creates important opportunities to reduce premature deaths from non-communicable diseases (WHO 2018). Mobile health technology mainly focuses on the use of mass media such as mobile phone-based or connected interventions (Gandapur et al. 2016; Karmakar et al. 2018). The near ubiquity, mobility, and direct and instantaneous nature of mobile phones and other mobile devices have enormous potential to impact healthcare delivery and health outcomes (White et al. 2016; Morawski et al. 2017; Gong et al. 2020). In the meta-analysis, it was seen that mobile health applications have a beneficial effect in health interventions to create behavior change (Iribarren et al. 2021). Another meta-analysis showed that messages given in behavior change interventions, including reducing salt intake in food, increasing physical activity, quitting smoking, increasing consumption of low-fat diet and fruit and vegetables, resulted in a significant reduction in blood pressure, in particular (Saif-Ur-Rahman et al. 2019).

In our study, the Protection Motivation Theory (KMT) will be used together with the use of mobile phones in creating behavior change. KMT is a common framework describing the use of protective behaviors and can be applied to interventions designed to change behavior (Rogers 1983). In this context, this study aims to evaluate the effects of nursing interventions including mobile phone use and patient education based on CMT on drug compliance and healthy lifestyle behaviors in hypertensive patients.

Detailed description: In this study, which was conducted to determine the effect of nursing interventions based on the Protection Motivation Theory on drug compliance and healthy lifestyle behaviors in patients with hypertension, 78 adult participants aged 40 to 59 years were randomized, pre-tested using antihypertensive drug treatment compliance and healthy lifestyle behaviors scale and blood pressure measurement. A study will be conducted in a test, post-test controlled design.

The Universe of the Research:The research population consists of 407 individuals with primary hypertension between the ages of 40-59 who are registered to the Family Health Center (FHC) No. 7 located in Karaman province in Turkey.

Sample of the Research:In this study, "G. The sample size was calculated at the 95% confidence level by using the "Power-3.1.9.2" program. For the calculation, Özpancar's (2013) study in which the effect of the training given by the nurse on the adherence to treatment in patients with hypertension was examined was used. The number of samples required for this calculation is 0.05 alpha value for the Mann Whitney U test; The minimum sample size was determined as 35 for each group (35 people for the control group + 35 people for the experimental group; 70 people in total) by taking an effect size of 0.90 and the theoretical power of 95%. A large sample was accepted from the calculations, and with this, considering the data loss during the research process, 10% of the calculated sample size will be taken, and a total of 78 patients will be studied on 39 experimental and 39 control group patients.

Data Collection Technique and Tools:In collecting the data of the research; Exclusion Criteria Form, Socio-demographic Information Form, Scale of Adherence to Antihypertensive Drug Treatment, Healthy Lifestyle Behaviors Scale, Blood Pressure Measurement Form, Telephone follow-up form, and short message service follow-up chart will be used. Data will be collected by the researcher by face-to-face interview method.

Exclusion Criteria Form:This form was created according to the exclusion and inclusion criteria of the study in order to determine the participants to be included in the study. The form consists of a total of 7 questions (age, education level, diagnosis of primary hypertension, a second chronic disease, being pregnant or breastfeeding, using a mobile phone, compliance with antihypertensive medication) and 1 decision to be included in the study.

Socio-demographic Information Form:This form was created by researchers as a result of literature review (Hacıhasanoğlu et al. 2012; Ercil et al. 2018; Deniz Akan et al. 2020; Ministry of Health 2021). The form consists of 20 questions in total. 9, which determine the socio-demographic characteristics of individuals (age, weight, height, gender, marital status, education status, employment status, monthly income, lifestyle), and related to hypertension (time of diagnosis of hypertension, number of anti-hypertensive drugs used daily, anti-hypertensive drugs used daily). duration of hypertensive drug use, regular use of hypertension drug/medication, place of follow-up treatment, family history of hypertension, special diet for hypertension, daily tea/coffee consumption, smoking status, alcohol use, regular exercise) 11 questions It consists of a total of 20 questions.

Scale of Adherence to Antihypertensive Drug Treatment:The Turkish validity and reliability of the scale developed by Morisky, Green and Levine were made by Demirezen and Nahcivan (Demirezen and Nahcivan 2006). There are a total of 9 statements in the scale that define drug-taking behavior. In the first 8 questions, answers are answered as Yes and No, and yes answers are coded as "1" and no answers as "0". In the ninth question, there are "1" never/rarely, "2" sometimes, "3" sometimes, "4" usually, "5" always and only one option is selected. The Cronbach's alpha coefficient of the scale was reported as 0.82 in the whole scale. The total score of the scale varies between '1-13'. In the aforementioned study, the definitions of compatible and incompatible with antihypertensive drug treatment were determined according to the 80% cut-off point. Accordingly, individuals who scored "1-7" according to the total scale score were defined as compatible with the treatment, while participants who scored "8 and above" were defined as non-adherent to the treatment. Deniz Akan et al. (2020), the Cronbach alpha coefficient of the scale was found to be 0.85.

Healthy Lifestyle Behaviors Scale:Healthy behaviors were collected with the "Healthy Lifestyle Behaviors Scale". Scale, Walker et al. (1987) and revised again in 1996 (Walker and Hill-Polerecky 1996). The scale measures health-promoting behaviors associated with an individual's healthy lifestyle. The scale consists of 52 items in total and has 6 sub-factors. Subgroups are spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. The overall score of the scale gives the healthy lifestyle behaviors score. The lowest score for the whole scale is 52, and the highest score is 208. All items of the scale are positive. The rating is in the form of a 4-point likert. Never (1), sometimes (2), often (3), regularly (4). The Cronbach Alpha coefficient of the original scale is 0.94, and the Cronbach Alpha values of the sub-dimensions of the scale vary between 0.79 and 0.87. The scale was adapted into Turkish by Bahar et al. (2008). In this study, the Cronbach alpha reliability coefficient was 0.92 and the reliability coefficients of the sub-dimensions of the scale were; Health responsibility 0.77, Physical Activity 0.79, Nutrition 0.68, Spiritual Development 0.79, Interpersonal Relations 0.80, Stress Management 0.64.

Blood Pressure Measurement Form:Blood pressure will be measured by the researcher with a calibrated mercury-manual sphygmomanometer (Erka Perfect Aneroid/Germany) and stethoscope. Blood pressure values were evaluated according to the information in the Turkish Hypertension Consensus Report (Aydoğdu et al. 2019), and blood pressure values lower than 120/80 mmHg were defined as "well-managed" and individuals with values above that "mismanaged". The stages followed in blood pressure measurement according to the Directive on Family Medicine Screening and Follow-up Coefficient, the Turkish Hypertension Consensus Report and the Office Blood Pressure Measurement criteria specified in the American Heart Association are listed below.

Step 1: The patient should rest quietly and comfortably for 5 minutes with his feet flat on the floor and remove the clothes from the arm to be measured.

Step 2: Supporting the patient's arm at the level of the right atrium and placing the cuff on the bare arm.

Step 3: Palpating the radial artery and inflating the cuff 20-30 mmHg after the loss of the pulse, then relaxing the cuff pressure to 2 mmHg per second and listening for the Korotkoff sounds.

Step 4: Determining the first heard sound (Korotkoff 1) as systolic blood pressure, and the last Korotkoff sound as diastolic blood pressure.

Step 5: Take two measurements 1-2 minutes apart and take the average of the two readings 6th step: Oral and written presentation of systolic blood pressure and diastolic blood pressure values to the patient Data Collection:The data will be collected by the researcher by face-to-face interview after obtaining the informed consent of the patient at the FHC No. 7 affiliated to the Karaman Provincial Health Directorate in Turkey.

Personal Information Form:Pre-tests before work Scale of Adherence to Antihypertensive Drug Treatment:Pre-tests before work, End of intervention Final and Follow-up test (at the end of 6th month) Healthy Lifestyle Behaviors Scale:Pre-tests before work, End of intervention Final and Follow-up test (at the end of 6th month) blood pressure measurement:Pre-tests before work, End of intervention Final and Follow-up test (at the end of 6th month) Variables of the Study:Dependent variables: Antihypertensive medication adherence scale mean score, healthy lifestyle behavior scale mean score, systolic and diastolic blood pressure.

Independent variables: Nursing interventions based on the Protection Motivation Theory Statistical Evaluation of Data:In the statistical evaluation of the data, number, percentage, mean and standard deviation values will be calculated for descriptive statistics. In order to compare the variables with each other, t-test and analysis of variance will be used in independent groups in cases where the dependent variable is normally distributed, and Mann Whitney U test and Kruskal Wallis test in cases where it does not show normal distribution. In comparison of dependent groups, t test, mITT, ITT, effect size (d), confidence interval calculations will be made in dependent groups. In statistical analyzes, the confidence level will be 95% and the power level (1-β) will be 95%.

Randomization:The socio-demographic data obtained from FHC No. 7, where the research will be conducted, showed that hypertensive individuals were similar in terms of control variables (age, gender, educational status and income level). For this reason, stratification will not be used in our study while determining the sample of the research. In the first stage, hypertensive individuals with a score of "8 and above", defined as non-adherent to treatment, will be determined by using the scale of adherence to antihypertensive drug therapy. This process will continue until the determined sample number is reached. In the second stage, a list will be created after the participants are reached. Hypertensive individuals will be numbered in the created list. Afterwards, participants will be placed in intervention and control groups online at www.random.org. The flow chart of the control and intervention groups has been prepared in accordance with the directive specified in CONSORT 2022 (CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials (bmj.com) Accessed June 7, 2023).

Masking:It is essential that those conducting the randomized controlled experimental study and the participants do not know who is in the control group and who is in the initiative during the assignment process until the study starts (Akın and Koçoğlu 2017). In this study, random selection and assignment will be made by a person other than the researcher, and a blind technique will be applied by hiding who is in the control and intervention groups from the researcher until the nursing interventions based on CMT are started. Thus, selection bias in the study will be controlled. In this study, the researcher will not be blinded during the intervention. Patients will not be blinded as consent will be obtained for the application to be made to them. Since the purpose of the nursing profession is to produce practice-related information in the real world beyond the boundaries of the laboratory, it is stated that the operational approach will more accurately reflect the nursing practice, but blinding in pragmatic experiments may be difficult (ethical, practical, etc. and blinding those who perform the data analysis (Akın and Koçoğlu 2017). For this purpose, in order to prevent bias in the evaluation of data; Statistical analyzes of the data encoded in the prepared database will be carried out by a statistics expert independently of the researcher. The coding for the control and intervention groups will be explained after the statistical analyzes of the study and the tables suitable for the results are made and the research report is written. Thus, blinding can be made in terms of statistics specialist and reporting. After randomization, Intention to treat analysis (ITT) will be applied to prevent reduction bias due to lack of data in result/output measurements during the study process. In this way, selection, deduction, statistical and reporting bias will be controlled.

Eligibility criteria: Inclusion Criteria:

* Those diagnosed with primary hypertension
* 40 to 59 years old (59 inclusive) \*
* Mobile phone user to receive the SMS to be sent by the researcher.
* At least literate and able to speak Turkish
* Participants who use antihypertensive drugs who do not have communication problems in terms of hearing, vision and understanding and who score "8 and above" according to the compliance scale, defined as non-adherent to treatment were decided to be included in the study

Exclusion Criteria

* Having a second chronic disease
* Those with mental or communication problems
* Those with secondary hypertension (Addison's disease, Renal artery stenosis, Hypo/hyperthyroidism, Parenchymal kidney disease, Cushing's Disease)
* Pregnant or lactating,

Primary outcomes:
measure: Scale of Adherence to Antihypertensive Drug Treatment
timeFrame: 1. Measurement: Before the intervention (pre-tests - first month) 2. Measurement: After the intervention (at the end of the 4th month of the study) 3. Measurement: the follow-up test (post-tests - at the end of the 6th month).
measure: Healthy Lifestyle Behaviors Scale
timeFrame: 1. Measurement: Before the intervention (pre-tests - first month) 2. Measurement: After the intervention (at the end of the 4th month of the study) 3. Measurement: the follow-up test (post-tests - at the end of the 6th month)
Secondary outcomes:
measure: blood pressure measurement
timeFrame: 1. Measurement: Before the intervention (pre-tests - first month) 2. Measurement: After the intervention (at the end of the 4th month of the study) 3. Measurement: the follow-up test (post-tests - at the end of the 6th month)
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Family Health Center No. 7 affiliated with Karaman Provincial Health Directorate
Study officials:
affiliation: dcingil@erbakan.edu.tr
name: Dilek CİNGİL
role: STUDY_DIRECTOR
References: