Effect Of Self-Management Program Wıth Tele-Nursıng Based On Roper-Logan-Tıerney Model On Self-Care Of Hypertensıon Patıents: A Randomızed Controlled Trıal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Scale of Adjustment to Chronic Diseases (CHU)
研究概览
简要总结
The purpose of this research; The aim of this study is to examine the effects of self-management support given by tele-nursing for hypertension patients on patients' adherence to treatment and disease, self-efficacy level, self-care management and satisfaction level. This research is a randomized controlled and pretest-posttest applied design. The research will be carried out in Van Yüzüncü Yıl University Research Hospital with patients previously diagnosed with hypertension. The population of the research will consist of patients who have previously applied to the hospital where the research will be conducted and who have been diagnosed with hypertension who meet the research criteria. After the power analysis, it is planned to include total 60 hypertension patients in the sample of the study. All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application, and their consent will be obtained. The pretest forms required for the research will be filled in by face-to-face interview method for all patients. In the study, the number of individuals in the randomization group will be determined by using the computer program, provided that they are equal in number. All materials prepared for self-management support will be delivered to the patients in the intervention group and they will be taught how to use them by the demonstration method. Patients will be asked to do the same procedure and the process will continue until they ensure correct use. Participants will be informed that there is a phone number that they can call whenever they want, when there are subjects that are not understood or that need to be repeated. Patients will be called three times a week and necessary checks will be made on blood pressure monitoring, nutrition, weight control, etc. In this way, patients in the intervention group will be followed remotely by tele-nursing for 3 months, their questions will be answered when they encounter problems, and guidance will be given in case of emergency. No intervention will be made in the control group. Necessary forms will be re-administered to all patients in both groups after 3 months as a post-test. At the end of the research, a comparison of the intervention and control groups will be made.
详细描述
Type of research This project is a randomized controlled and pretest-posttest applied design. Location and Characteristics of the Research The research will be carried out in Van SBU Training and Research Hospital Research Hospital with patients who have been diagnosed with hypertension before.
The number of cardiology outpatient clinics of Van Training and Research Hospital is 5. In our hospital, there are cardiology and internal departments that also include hypertension patients. There are 70 patients per day per cardiology outpatient clinic. The majority of them are individuals with hypertension and hypertension, as well as additional chronic diseases. It is questioned whether individuals follow their weight, whether they change their eating and drinking habits, whether they use their medications regularly, and finally whether they follow their blood pressure regularly. After this questioning, examination and various tests (blood analysis, ultrasound, etc.), the medicines of the patients are regulated. In general, patients are called for control every 2 months. However, this period is extended for individuals who take the warnings into account, measure their blood pressure regularly and see that it is stable at the expected level.
Research Population and Sample Selection The population of the research will consist of patients who have previously applied to the hospital where the research will be conducted and who have been diagnosed with hypertension who meet the research criteria.
The sample was calculated using the Hill-Bone Hypertension Treatment Adherence Scale, which was used in 2 studies. In order to determine the sample size, a priori power analysis was performed and it was determined that at least 28 hypertension patients were required for each of the intervention and control groups in order for the power of the study to exceed 80% at the 95% confidence interval, 0.05 significance level and medium effect size. In case of data loss, a total of 60 (total) data will be collected by including 10% backup sample to this number. After the posttest data are collected, the power analysis will be looked at again. In the final power analysis, this rate is expected to exceed 90%.
Data Collection All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application. "Informed Consent Form" will be filled in for the patients who agree to participate in the study. Then, the pre-test forms will be filled in by face-to-face interview method for all patients in the intervention and control groups.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Follow-up for at least 6 months with the diagnosis of essential hypertension,
- •Using antihypertensive drugs,
- •No change in antihypertensive drug treatment in the last 1 month,
- •Not having any other accompanying chronic disease (Diabetes mellitus, cancer, chronic kidney failure, chronic obstructive pulmonary disease, heart failure, etc.),
- •Having no mental or communication problems,
- •Computer/tablet/smartphone etc. to watch videos. having technological tools,
- •Having internet,
- •Being over 40 years old,
- •Having at least primary education level,
- •Not being pregnant or lactating,
排除标准
- •Follow-up for less than 6 months with the diagnosis of essential hypertension,
- •Not using antihypertensive drugs,
- •Changes in antihypertensive drug therapy in the last 1 month,
- •Presence of another concomitant chronic disease (Diabetes mellitus, cancer, chronic kidney failure, chronic obstructive pulmonary disease, heart failure, etc.),
- •Having a mental or communication problem,
- •Computer/tablet/smartphone etc. to watch videos. lack of technological tools,
- •Lack of internet,
- •Being under the age of 18,
- •Being illiterate
- •Being pregnant or breastfeeding,
结局指标
主要结局
Scale of Adjustment to Chronic Diseases (CHU)
时间窗: 3months
In the scale with three sub-dimensions and 25 items; physical adaptation, items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, 24 (maximum 55, minimum 11 points), social adaptation; Items 2, 3, 5, 7, 17, 19, and 25 (maximum 35, minimum 7 points), psychological adjustment; Items 4, 6, 8, 11, 12, 20, 21 (maximum 35, minimum 7 points) measure. The total score taken from the scale is 125. An increase in the scores obtained from the sub-dimensions and/or the whole scale means that the patients' level of compliance with the disease also increases.
Hill-Bone Hypertension Treatment Adherence Scale (HBHTUS)
时间窗: 3months
The scale consists of 14 questions. On a four-point Likert scale (0=never, 1=sometimes, 2=often, and 3=always), interview (6, 7, and 8th items), medical (1, 2, 9, 10, 11, 12, 13) and 14. items) and nutrition (3, 4 and 5 items). Except for the 6th question of the scale, all of the other questions are in the form of negative questions. The total scores obtained from the scale range from 0 to 42, with a score of 0 indicating perfect adherence to treatment. A high total score from the scale indicates a decrease in adherence to treatment.
Self-Care Management Scale in Chronic Diseases (KHÖBYÖ)
时间窗: 3months
The scale consists of 35 items and is in a five-point Likert type (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree). Self-protection (items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23, 25-34), and social protection (1, 3, 4, 5, 7, 9, 10, 12) There are two sub-dimensions (items 13, 14, 16, 17, 21, 24 and 35). Items 3, 15, 19 and 28 in the scale are negative statements. The total scores that can be obtained from the scale vary between 35-175 points, and an increase in the score indicates that the individual's self-care management also increases.
The 6-item Self-Efficacy for Managing Chronic Diseases Scale(SEMCD6)
时间窗: 3months
It is an easy-to-use and effective tool for assessing the self-efficacy levels of patients with chronic diseases. The scale is rated on a 10-point scale ranging from "not at all sure" to "very sure". The score obtained from the scale is the average of 6 items, and high scores indicate high self-efficacy. If more than 1 answer is given to an item and the items are consecutive, the low score is included in the calculation. If the 2 answers given are not consecutive, this item is excluded from the calculation. In order for the scale to be calculated, at least 4 items must be answered.
次要结局
未报告次要终点
研究者
Bahar Ciftci
Principal Investigator
Ataturk University