Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Controlling blood pressure
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are:
- How effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care?
- How effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care?
Participants will undergo four visits. Two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). These will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. Visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy.
Researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.
详细描述
Specific objectives
- Characterize the clinical and socio-demographic profile of the studied population.
- Compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups.
- Evaluate patient adherence to medication treatment in the teleconsultation group and in person
- Evaluate patient satisfaction in the teleconsultation group and in-person consultation.
- Compare satisfaction between the telepharmacy and in-person (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
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription.
- •Patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included;
- •Patients must have a cell phone and know how to use it;
- •Patient not have previously received pharmaceutical care.
排除标准
- •Elderly people who are unable to use their cell phones due to cognitive impairments (Mini Mental State Examination (MMSE).
- •Elderly person considered unable of using a telephone (Instrumental Activities of Daily Living)
- •Elderly with controlled blood pressure according to home monitoring.
结局指标
主要结局
Controlling blood pressure
时间窗: 3 months
Rate of patients reaching the blood pressure target for healthy elderly people: systolic pressure of 130-139 mmHg and diastolic pressure of 70-79 mmHg; and for frail elderly people: systolic pressure of 140-149 mmHg and diastolic pressure of 70-79mmHg according to guidelines from the Brazilian Society of Cardiology of 2020
次要结局
- Adherence to the treatment(3 months)
- Level of clinical significance of interventions(3 months)
- Patient satisfaction(3 months)
研究者
Márcio Galvão Guimarães de Oliveira
Adjunct Professor
Federal University of Bahia