The Effect of Nursing Interventions Based on Protection Motivation Theory on Drug Adherence and Healthy Lifestyle Behaviors in Patients With Hypertension: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Scale of Adherence to Antihypertensive Drug Treatment
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- 未提供
结局指标
主要结局
Scale of Adherence to Antihypertensive Drug Treatment
时间窗: Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).
It was developed by Morisky, Green and Levine. 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 one option is marked. 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.
Healthy Lifestyle Behaviors Scale
时间窗: Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).
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. Higher values represent a better result. 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.
次要结局
- Systolic Blood Pressure(Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).)
- Diastolic Blood Pressure(Outcomes were assessed at one month (T₀), after the interventions (approximately 3.5 months after baseline) (T₁) and at the end of the sixth month (T₂).)
研究者
Handan Altunkan
Principal İnvestigator
Necmettin Erbakan University