The Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes in Essential Hypertension Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from Baseline Systolic and Diastolic Blood Pressure at 3 months
研究概览
简要总结
The primary aim of this study is to determine the effects of education and motivational interviews structured according to the health belief model on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis. The secondary aim of the study is to determine the effects of the variables that mediate the probability of performing primary prevention measures according to the health belief model of patients with a diagnosis of essential hypertension. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 6-month follow-up period. The research will be carried out at Işıklar Family Health Center located in Eskişehir city center in Turkey. The study population of this research consists of 659 patients with a diagnosis of essential hypertension, aged between 30-59 years, registered in Işıklar Family Health Center. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 80 individuals, 40 in each group, with an increase of 20%, will form the research group. The research data collection process will be carried out in 4 stages. First of all, the data required to query the inclusion criteria and exclusion criteria for participant admission to the study will be evaluated using the "Data form for participant admission". For the other stages of the research data collection process; "Pre-test (Beginning at 0 months)", "Intermediate follow-up test (Follow-up at 3 months)" and "Posttest (6 months)" will be administered to the participants in the study and control groups by the researcher. In this study, "Cardiovascular Disease Risk Awareness Assessment Scale", "Cardiovascular Diseases Risk Factors Knowledge Level", "Framingham Cardiovascular Risk Score", "Healthy Lifestyle Behaviors Scale-II", "Hypertension Self-Care Profile", "Hill- Bone Hypertension Treatment Adherence Scale", "Physical Activity Questionnaire for Primary Care" and "SF-12 Quality of Life Scale" will be used as data collection tools. In addition to their routine care, the control group will be given a health education structured according to the health belief model and a training booklet on healthy lifestyle behavior changes at the end of the training.
详细描述
Hypertension plays an important role in the early death of 1 in 4 men and 1 in 5 women (more than one billion people) diagnosed with hypertension worldwide. Hypertension, the prevalence which can vary from country to country, is around 30-45% of the general population, and this rate is observed to increase with age, which will continue to be an important public health problem today and in the future. Worldwide, only one out of every 5 adults (about 21%) has hypertension under control. It is seen that the risk of cardiovascular morbidity and mortality is higher in patients whose blood pressure cannot be controlled. It is important to control hypertension in order to prevent cardiovascular diseases (CVD), also patients should comply with their treatment and health recommendations.
Motivational interviewing is a client-centered communication technique that reveals the behavior change and desire for change by helping the person to understand the problem or problems arising from himself, to discover the problem, to discover and solve the ambivalence.In this study, it is thought that motivational interviews structured according to the health belief model can be effective on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
In the study, participants will be left unaware of whether they are in the study or control group (single-blind masking).
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the research
- •Those who are registered with any of the family physicians in the Family Health Center where the research will be conducted.
- •Being in the age range of 30-59
- •Having a physician-diagnosed essential hypertension
- •Having estimated 10-year CHD risk ≥ 10% based on the Framingham risk score
- •Being a literate
排除标准
- •Having a disease like coronary artery disease, heart failure, angina, myocardial infarction, cerebrovascular diseases, cancer, or kidney failure.
- •Having a pacemaker
- •Having a disease like chronic obstructive pulmonary disease, neurological disorder, or psychosis and schizophrenia with severe mental illness
- •Has a learning disability or communication disability
- •Being pregnant
- •Being morbid obese (BMI ≥50 kg/m2)
研究组 & 干预措施
Study group
Study group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up.
干预措施: 6-session motivational interviews (Behavioral)
Study group
Study group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up.
干预措施: Health education structured according to the health belief model (Other)
Study group
Study group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up.
干预措施: Training booklet prepared by the researchers on healthy lifestyle behavior changes (Other)
Study group
Study group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up.
干预措施: 6 month follow-up (Other)
Control group
Control group intervention consists of a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and a 6-month follow-up.
干预措施: Health education structured according to the health belief model (Other)
Control group
Control group intervention consists of a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and a 6-month follow-up.
干预措施: 6 month follow-up (Other)
Control group
Control group intervention consists of a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and a 6-month follow-up.
干预措施: Training booklet prepared by the researchers on healthy lifestyle behavior changes (Other)
结局指标
主要结局
Change from Baseline Systolic and Diastolic Blood Pressure at 3 months
时间窗: 3rd month
Systolic and diastolic blood pressure
Change from Baseline Systolic and Diastolic Blood Pressure at 6 months
时间窗: 6th month
Systolic and diastolic blood pressure
Change from Baseline Healthy Lifestyle Behaviors at 6 months
时间窗: 6th month
"Healthy Lifestyle Behaviors Scale II" will be used to determine the healthy lifestyle behavior changes of the participants. A minimum of 52 and a maximum of 208 points can be obtained from the scale. Increasing scores from the scale indicate that individuals develop positive healthy lifestyle behaviors.
Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 3 months
时间窗: 3rd month
The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score". According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of \<10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk. The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%. Persons with a 30-year risk score of \< 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 6 months
时间窗: 6th month
The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score". According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of \<10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk. The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%. Persons with a 30-year risk score of \< 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
次要结局
- Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 3 months(3rd month)
- Change from Baseline Physical Activity Level at 6 months(6th month)
- Change from Baseline Life Quality at 6 months(6th month)
- Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months(6th month)
- Change from Baseline Compliance Level for Hypertension Treatment at 6 months(6th month)
- Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 6 months(6th month)
- Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months(3rd month)
- Change from Baseline Motivation Level, Behavior Level and Self-efficacy Level in Hypertension Self-care at 6 months(6th month)
研究者
Pınar Duru
Assistant Professor Doctor
Eskisehir Osmangazi University