Nursing Interventions Based on Protection Motivation Theory in Hypertensive Patients

NCT ID: NCT05995977

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-05-30

Brief Summary

Hypertension is a major global public health problem. In order to be successful in hypertension management, patients should receive timely and accurate diagnosis, acquire healthy lifestyle habits, start antihypertensive drug treatment on time, and ensure compliance with treatment. The study was conducted in a pre-test-post-test parallel group randomized controlled design in order to determine the effects of nursing interventions consisting of Rogers' Protection Motivation Terosine-based hypertension education and sending short messages to hypertensive individuals on medication compliance and healthy lifestyle behaviors. The study was conducted in Karaman Province, Family Health Center No. 7 between November 2023 and May 2024. The study group consisted of individuals aged between 40-59 years, with low compliance to treatment, no communication problems in terms of hearing, vision and understanding, using mobile phones, and diagnosed with primary hypertension. The study was conducted with a total of 78 participants, 39 in the intervention group and 39 in the control group, calculated with 95% power. Before starting the study, ethics committee, institution, scale usage permission and written consent were obtained from the participants. Data were collected using Personal Information Form, Antihypertensive Drug Treatment Adherence Scale, Healthy Lifestyle Behaviors Scale, Blood Pressure Monitoring Form at the beginning (T₀), end of the third month (T₁) and end of the sixth month (T₂). Multiple nursing interventions consisting of hypertension education, brochure and 14-week short messages were applied to the intervention group. No intervention was applied to the control group. Measurements were collected by face-to-face interview method. Blinding was applied in terms of statistics expert and reporting. Data analyses in this study were performed using IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) program. After the applied nursing interventions, a significant difference was found between the total mean score of the Antihypertensive Drug Treatment Adherence Scale, the mean score of the Healthy Lifestyle Behaviors Scale, and systolic blood pressure and diastolic blood pressure values of the intervention and control groups (p<0.05). As a result, applicable, economical interventions combining health education and technology can be recommended as an important tool in health services to reduce the burden of hypertension in society.

Detailed Description

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

Research Universe: The research universe consists of 407 individuals with primary hypertension between the ages of 40-59 registered at the Family Health Center (ASM) No. 7 in Karaman, Turkey.

Sample of the Study: In this study, "G. Sample size was calculated at a 95% confidence level using the "Power-3.1.9.2" program. Özpancar's (2013) study was used for the calculation. 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 70 people in total, 35 for each group (intervention and control), by taking the effect size of 0.90 and the theoretical power of 95%. The 10% loss rate in previous studies was taken into account and it was decided to include a total of 78 participants, 39 in each group. Data Collection Technique and Tools: In the collection of data; Exclusion Criteria Form, Personal Information Form, Antihypertensive Drug Treatment Adherence Scale, Healthy Lifestyle Behaviors Scale, Blood Pressure Monitoring Form, Telephone follow-up form, and short message service follow-up chart were used.

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, primary hypertension diagnosis, a second chronic disease, pregnancy or breastfeeding status, mobile phone use, compliance with antihypertensive drug treatment) and 1 decision to include in the study.

Socio-demographic Information Form: This form was created as a result of literature review. The form consists of a total of 20 questions. 9 determine the socio-demographic characteristics of individuals (age, weight, height, gender, marital status, education status, employment status, monthly income, lifestyle) and are related to hypertension (time of hypertension diagnosis, number of anti-hypertensive drugs used daily, anti-hypertensive drugs used daily). It consists of a total of 20 questions, 11 of which are about duration of hypertensive medication use, regular use of hypertension medication/medicine, place of follow-up treatment, family history of hypertension, diet specific to hypertension, daily tea/coffee consumption, smoking status, alcohol use, regular exercise).

Antihypertensive Medication Adherence Scale: The Turkish validity and reliability of the scale developed by Morisky, Green and Levine was conducted by Demirezen and Nahcivan. The scale includes a total of 9 statements that diagnose medication-taking behavior. The first 8 questions are answered as Yes and No, and yes answers are coded as "1" and no answers as "0". The ninth question has the options "1" never/rarely, "2" occasionally, "3" sometimes, "4" usually, "5" always, and only one option is selected. In scoring, Yes = 0 points and No = 1 points are evaluated in questions 5 and 6, while Yes = 1 and No is evaluated as 0 in other questions. The last question, item 9, is Likert-type and is evaluated between 1-5. The Cronbach's alpha coefficient of the scale was reported as 0.82 in the entire scale. In the study in question, the definitions of compliance and non-compliance with antihypertensive drug treatment were determined according to the 80% cut-off point. In this study, Cronbach's Alpha reliability coefficient was found as 0.674 in the first measurement, 0.797 in the second measurement and 0.748 in the third measurement. An increase in the score in the evaluation of compliance with antihypertensive drug treatment indicates that the individual is "non-compliant". The total scale score varies between '1-13'. Accordingly, individuals who score "1-7" according to the total scale score while participants who scored "8 and above" were defined as non-compliant with treatment.

Healthy Lifestyle Behaviors Scale: Healthy behaviors were collected with the "Healthy Lifestyle Behaviors Scale". The scale was developed by Walker et al. (1987) and revised again in 1996. The scale consists of a total of 52 items and has 6 sub-factors. The sub-groups are spiritual development, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. All items of the scale are positive. The lowest score for the entire scale is 52, the highest score is 208. The rating is in the form of a 4-point Likert. It is accepted as 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 0.79-0.87. The scale was adapted to Turkish by Bahar et al. (2008). In the study in question, the Cronbach alpha reliability coefficient was determined as 0.92. In this study, Cronbach's Alpha reliability coefficient was found to be 0.904 in the first measurement, 0.928 in the second measurement and 0.926 in the third measurement. The scale measures the health-improving behaviors of the individual in relation to a healthy lifestyle.

Blood Pressure Measurement Form: Blood pressure was measured by the researcher with a calibrated mercury-manual sphygmomanometer (Erka Perfect Aneroid/Germany) and a stethoscope.

Data Collection: Hypertensive individuals who agreed to participate in the study were first asked to fill out a pre-test form. The interviews were first conducted face-to-face by the researcher in the training hall of the Family Health Center. After nursing interventions (Hypertension Education Presentation November - December 2023, SMS message sending December 2023 - March 2024), interim measurement data were collected. Post-tests were performed at the end of the sixth month.

Study Variables: Dependent variables: Antihypertensive drug compliance scale mean score, healthy lifestyle behavior scale mean score, systolic and diastolic blood pressure. Independent variables: Nursing interventions based on Protection Motivation Theory Statistical Evaluation of Data: In this study, data analyses were performed using the IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) program. Descriptive statistics were given as number of units (n), percentage (%), mean (X), standard deviation (SS), median (M), minimum (min) and maximum (max) values. Reliability for scales and their sub-dimensions was examined using Cronbach's Alpha coefficient. Scales with a Cronbach's Alpha coefficient above 0.60 were considered reliable. Skewness and kurtosis values were examined to test whether the data met the assumption of normality. In the decision phase, if the absolute skewness (Skewness) value is below ± 2.0 and the kurtosis value is below 7.0, it is decided that the data is normally distributed. Accordingly, the data in the study was found to be suitable for normal distribution. In the comparison of numerical descriptive characteristics of the patients between groups, independent sample t test was used, and in the comparison of categorical descriptive characteristics between groups, chi-square tests (Pearson chi-square/Fisher exact test) were used. Mixed order analysis of variance (ANOVA) was used in the comparison of variables in the groups according to follow-up times. Bonferroni correction was applied in the comparison of main effects in the analyses. The value of p<0.05 was considered statistically significant. Intention to treat (ITT) analysis was used in the evaluation of the data. ITT is a basic method used in maintaining randomization and preventing bias in case of withdrawal from the study. Since it was not possible to reach 7 individuals who left the research process for the ITT analysis of this study, the post-tests were filled by repeating the answers given by the patients in the pre-tests, and the missing data were completed in this way.

Randomization: Socio-demographic data (age, gender, education level and income level) of hypertensive patients from the 7th FHC where the study was to be conducted were obtained as a list and found to be similar. Therefore, no stratification was applied in the study while determining the sample of the study. In the first stage of the study, hypertensive individuals defined as non-adherent to treatment (scoring "8 and above") were determined by using the antihypertensive drug treatment compliance level scale for individuals registered in the 7th FHC and continuing antihypertensive drug treatment. This process was continued until the specified sample size (n: 78) was reached. Each individual to whom the scale was applied was given a number from 1 to 78 according to the application order and a list was created. In the second stage, participants were assigned to the intervention and control groups from the web page (https://www.random.org/) according to the simple randomization method based on the order in the list created. In this assignment, the assignment of the groups was made by an expert in order to ensure blinding. The flow chart of the control and intervention groups was prepared in accordance with the guidelines specified in CONSORT 2022.

Masking: Patients were invited to the study by the researcher involved in the study and participant registration was carried out until the targeted sample size (78 participants) was reached. During participant registration, the names and contact information of the patients were collected, and it was stated that they would be contacted and called for the process related to the study. When the targeted sample size was reached in the study, participant registration was terminated and a participant list was created. Random selection and assignment were made in the study by a person other than the researcher using the created participant list. Thus, selection bias was controlled in the study. After the groups were determined, the patients were not blinded since their consent would be obtained for the application to be made to them during the intervention process. In this study, a blind technique was applied by hiding who was in the control and intervention groups until the nursing interventions based on KMT started. However, the researcher was not blinded during the intervention period. In order to prevent bias in the evaluation of the data; statistical analyses of the coded data (A and B) in the prepared database were performed by a statistician independent of the researcher. After the statistical analyses of the study and appropriate tables for the results were made and the research report was written, the codings for the control and intervention groups were explained. Thus, statistician and reporting blinding was performed during the research process. Intention to treat analysis (ITT) was applied to prevent attrition bias due to missing data in the outcome/outcome measurements during the study process after randomization. In this way, selection, attrition, statistical and reporting bias were controlled.

Conditions

Hypertension, Public Health; Nursing Staff

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group that applied nursing interventions

The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging and motivating patients to maintain medication adherence and healthy lifestyle changes.

Group Type: EXPERIMENTAL

Nursing interventions based on protection motivation theory in patients with hypertension

Intervention Type: BEHAVIORAL

The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.

Individuals who do not apply nursing interventions based on protection motivation theory

Control Group: Individuals who did not apply nursing interventions based on protection motivation theory in patients with hypertension

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nursing interventions based on protection motivation theory in patients with hypertension

The intervention consists of two components and is planned to last 14 weeks. The first component consists of hypertension education based on the Protection Motivation Theory. The second component is the sending of regularly delivered Protection Motivation Theory-based SMS messages aimed at reminding, encouraging, and motivating patients to maintain medication adherence and healthy lifestyle changes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants who have been diagnosed with primary hypertension (at least one year)
• Those between the ages of 40 and 59
• Those who use a mobile phone to receive SMS messages sent by the researcher
• Those who are at least literate and can speak Turkish
• Those who have no communication problems in terms of hearing, seeing and understanding
• Those who use antihypertensive medication and who score "8 and above" on the compliance scale and are defined as non-compliant with 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,

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Handan Altunkan

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilek CİNGİL

Role: STUDY_DIRECTOR

dcingil@erbakan.edu.tr

Locations

Family Health Center No. 7 affiliated with Karaman Provincial Health Directorate

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NecmettinEUHAltunkang9uxfp6y42

Identifier Type: -

Identifier Source: org_study_id