Home Blood Pressure Monitoring in Patients With Uncontrolled Hypertension: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in average Systolic and Diastolic Blood Pressure values
研究概览
简要总结
This study aimed to test Home Blood Pressure Monitoring (HBPM) in reducing blood pressure (BP) levels in individuals with uncontrolled hypertension. Data collection was conducted in 5 stages: 1) recruitment; 2) inclusion in the study and collection of baseline data, including information on sociodemographic issues, anthropometric and clinical profile, and adherence to medication treatment; 3) randomization; 4) intervention; and 5) Reassessment of adherence to medication treatment. All participants will be monitored by the research team in three follow-up visits at the unit. The intervention consisted of HBPM being performed by participants in the IG, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month. Participants in the CG did not perform HBPM, but were also monitored by the research team in their follow-up visits. In these follow-up visits, for both groups, the researchers performed new BP measurements using the oscillometric method.
详细描述
The outcome was the reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.
The Omron HEM-1100® automatic clinical monitor was used to perform oscillometric BP measurement in the unit.
The HEM 7122 automatic BP monitor was made available to IG participants for self-measurement of BP at home. The following were included:
- Patients diagnosed with hypertension associated or not with DM, CAD or RI;
- Time since diagnosis greater than 6 months;
- BP > 140/90 mmHg obtained in triplicate during an initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study;
- They had been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report;
- They were able to move around and attend follow-up appointments at the health unit. The random allocation of participants into the two groups (G1 and CG) was performed proportionally (1:1) using Research Randomizer 1, which generated the sequence of entry by sets (set 01: G1, Set 02: CG). The numbers generated were previously recorded in sealed envelopes, which were opened in the presence of the participants immediately after collecting the variables at baseline and completing the data collection instrument. After randomization, the researcher informed the IG participant that he would undergo the intervention with HBPM during the follow-up period of three consecutive appointments scheduled by the unit. To this end, he would be loaned an automatic BP monitor provided by the researcher for the duration of the study and that it should be returned at the end. The CG participant was also informed by the researcher about the monitoring by the research team, which would include taking BP measurements using the oscillometric method during the period of three consecutive return appointments scheduled by the unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The final data was anonymized before being made available to the statistician.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) Patients diagnosed with hypertension, whether or not associated with DM, CAD or RI; b) Time since diagnosis greater than 6 months; c) BP > 140/90 mmHg obtained in triplicate during the initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study; d) Having been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report; e) Having mobility conditions to attend follow-up consultations at the health unit.
排除标准
- •a) Pregnant women or women actively seeking to become pregnant; b) Have physical incapacity (represented by the presence of tetraplegia, tetraparesis, triplegia, triparesis, hemiplegia, hemiparesis, amputation or cerebral palsy), cognitive incapacity (represented by the presence of dementia, depression, delirium and mental illnesses, such as schizophrenia, oligophrenia and paraphrenia), and have undergone surgical procedures, accidents, amputation, oncological treatment that prevents self-monitoring of BP; c) Inability to maintain the monitor at home, represented by the participant's refusal to receive and/or keep the device; d) Acute cardiovascular event (myocardial infarction and stroke) in the last three months; e) Have a medical diagnosis of arrhythmia, as per the participant's self-report and confirmation in the medical record. f) Perform home BP measurement, represented by the participant's report. -
结局指标
主要结局
Reduction in average Systolic and Diastolic Blood Pressure values
时间窗: 9 months
Reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.
次要结局
未报告次要终点
研究者
Antonia Fabiana Rodrigues da Silva
Doutora
Universidade Federal do Ceara