The Role of Training And Medication Reminder Wristwatch in the Adherence to The Treatment in Geriatric Patients Diagnosed With Hypertension: A Randomized Controlled Trial (RoT-ReWiH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Antihypertensive Medication Treatment Adherence Scale (AMTAS)
研究概览
简要总结
This study is a randomized controlled study. The study was completed to with randomized selected 30 training and reminder by watch (experiment), 30 education (experiment) and 30 control group total of 90 hypertensive patients. Patients in the experimental group received training on hypertension and treatment adherence. In addition, the participants in the training and reminder by watch group wore a medication reminder wristwatch. Statistically significant differences were found in the post-test between scale scores of the experimental and control groups (p<.05). It was observed that the initial blood pressure measurements were high in the patients in all three groups, while the highest decrease was found in the training and reminder by wristwatch group at the final measurement (p<.05). Hypertension education program and using a medication reminder wristwatch were found to be effective in increasing treatment adherence.
详细描述
Design and Participants This study was conducted a randomized controlled trial. The population of the research was the patients who received service from this center, who were 65 years of age and older, who had hypertension, and who were using at least one antihypertensive drug (n=90). Power analysis was conducted to determine the sample size; it was based on the difference in Compliance with Drug Therapy Scale mean scores of hypertensive patients from previous studies.16 The sample size of at least 60 individuals was calculated by taking α = 0.05, power = 0.99, and effect size = 0.863. Keeping in mind that the number of participants may decrease during the study owing to factors such as a health problems or die , 90 subjects were included in the study.
Participants were randomized to medication reminder wristwatch group (n = 30), training group (n = 30) and control (n = 30) groups. In randomization, participants were stratified participants was ensured through the use of stratified sampling method. The patients in all three groups were stratified according to gender (female, male). The patients who were 65 and older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg or above prior to the research, who had a score of 8 and above from the Compliance with Drug Therapy Scale, and who were willing to participate were included in the study. The patients who met the inclusion criteria constituted the sample of the study.
A questionnaire form, Hypertension Information Form (HIF), Antihypertensive Medication Treatment Adherence Scale (AMTAS), Medication Adherence Self-Efficacy Scale Short Form (MASES-SF) were used to collect data. The questionnaire form was developed by using relevant literature and included 33 closed-ended questions about the sociodemographic, health/disease and treatment compliance characteristics of elderly individuals.
Hypertension Information Form (HIF) was prepared by the researcher in line with the literature in order to measure the effectiveness of the hypertension education program. It contains 26 statements about drug use, blood pressure monitoring, and disease management. The questions are Yes/No questions. The "yes" answers receive 1 point, while the "no" answers receive 0 point. The maximum score that can be obtained from the form is 26. A score of 13 and above indicates that patients' knowledge level about hypertension has increased. The current study found Cronbach α = 0.77.
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the medication behavior and the total score varies between 1 and 13. Individuals with a score between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8 and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was validated by Demirezen et al with Cronbach α = 0.82. In this study, the Cronbach's alpha of the scale was determined as 0.51.
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)
入排标准
- 年龄范围
- 65 Years 至 92 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who were 65 and older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg or above prior to the research, who had a score of 8 and above from the Compliance with Drug Therapy Scale, and who were willing to participate were included in the study.
排除标准
- •Being diagnosed with malignancy
- •İlliteracy
- •Having a history of cardiac intervention in the past year
- •Hearing-vision loss
研究组 & 干预措施
RoT-ReWiH
First, pre-tests were applied to the patients in the training and reminder by watch group at first home visit.Second home visits were conducted participants 12th weeks after the first home visit.One of the researchers presented the education program to individuals with hypertensive.The education program included issues related to hypertension, measurament of pressure blood, lifestyle changes and adherence to treatment. The program using face-to-face communication technique and lasted about 45 minutes.For the patients in this group, the alarm time was set according to the time when blood pressure medication was taken, the cord was adjusted according to the arm, and then information was given about the use of the watch. At the end of the interview, the blood pressure of the experimental groups was measured and the measurement value was recorded on the blood pressure follow-up card.
干预措施: The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH) (Behavioral)
Training group
First, pre-tests were applied to the patients in the training group at first home visit.The education program included issues related to hypertension, measurament of pressure blood, lifestyle changes and adherence to treatment. The program using face-to-face communication technique and lasted about 45 minutes. In addition, other drugs used by individuals at home (such as painkillers, antibiotics) were also evaluated during the home visit, and a red label was made on the antihypertensive drug box to distinguish antihypertensive drugs from other drugs. At the end of the interview, the blood pressure of the experimental groups was measured and the measurement value was recorded on the blood pressure follow-up card.
干预措施: The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH) (Behavioral)
Control group
Pre-tests was applied to the patients in the control group.No intervention was be applied to the patients in this group and second home visit 12th weeks after the first home visit and were readministered the post-tests.
结局指标
主要结局
Antihypertensive Medication Treatment Adherence Scale (AMTAS)
时间窗: 3 Month
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the medication behavior and the total score varies between 1 and 13. Individuals with a score between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8 and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was validated by Demirezen et al. with Cronbach α = 0.82. In this study, the Cronbach's alpha of the scale was determined as 0.51.
Medication Adherence Self-Efficacy Scale Short Form (MASES-SF)
时间窗: 3 Month
MASES-SF was developed in 2012 by Hacıhasanoğlu et al and include of 13 questions on a Likert scale. The total score of the scale is between 13 and 52, and an increase in the score indicates that the individual's level of compliance with antihypertensive drug treatment is good. The Cronbach's alpha was reported as 0.94. In this study, the Cronbach's alpha of the scale was found to be 0.83.
次要结局
未报告次要终点
研究者
Birsen ALTAY
Head of Nursing Department
Ondokuz Mayıs University
