Pragmatic Study of the Effectiveness of Pharmaceutical Teleconsultation in Adults With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 主要终点
- Change from Asthma Control test (ACT) score at 6 months
研究概览
简要总结
The investigators propose a pragmatic randomized clinical study, consisting of two groups, the control group with health education and the intervention group with teleconsultation. The research team comprises pharmacists, students, and professors who work in a pharmaceutical service of secondary health care linked to the public university. The investigators will conduct the study exclusively remotely, following the patients for six months. The research team will implement and structure an ambiance to adapt the face-to-face pharmaceutical consultation into the pharmaceutical teleconsultation. The evaluated outcomes, in both groups, will be the scores of the Asthma Control Test, the Asthma Quality of Life, and the hospitalization rate and admission to urgency/emergency services.
详细描述
It is a pragmatic, randomized, single-blind clinical trial based on a population of users diagnosed with asthma, registered in the Pharmaceutical Assistance Network in Porto Alegre (Rio Grande do Sul, Brazil). The study will be conducting exclusively by remote means, in the premises of the Collaborating Center for Pharmaceutical Services (CECOL-FAR), belonging to the Faculty of Pharmacy of the Federal University of Rio Grande do Sul (UFRGS). Characterized as a pharmaceutical service of secondary care, the CECOL-FAR/UFRGS, in the pre-pandemic COVID-19, used to provide assistance in face-to-face pharmaceutical consultations to patients who did not adhere to the asthma treatment.
The research team of the study, composed of pharmacists from CECOL-FAR/UFRGS, students and professors of the Postgraduate degree in Pharmaceutical Services (PPGASFAR) at UFRGS, will restructure and adapt the face-to-face pharmaceutical consultation for teleconsultation, with the creation of work processes, elaboration of research flows and standard operating procedures (SOP).
The pilot study, carried out through simulated situations, will evaluate these new practices regarding the processes' suitability, feasibility, and scope. After the pilot project adaptation, the documents will be applied to the study in the implementation of pharmaceutical teleconsultation.
Study participants will be drawn from the population of users diagnosed with asthma treated in Primary Health Care. The physician will apply the Asthma Control Test (ACT) to assess the control of asthma symptoms. For patients considered to have uncontrolled asthma, it will be verified whether it meets the other eligibility criteria for inclusion in the study. If the criteria are met, individuals will be referred for care at CECOL-FAR, via the system of regulation of specialized consultations of the Unified Health System (SUS), after medical consultation.
Once scheduled in the system, the research team will contact the patient via telephone and offer two types of service: pharmaceutical consultation, in which the patient must travel to CECOL-FAR on a date and time scheduled for face-to-face consultation or teleservice. Patients who opt for telecare will be invited to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma;
- •Age equal to or greater than 18 years;
- •ACT score less than 20 points;
- •Patients who can read and write;
- •Possibility of using the WhatsApp® application (by video call)
- •Acceptance by written or audio message, from the informed consent.
排除标准
- •Patients who do not attend the research team in the foreseen contacts, always in five attempts for each stage of the study, whether via telephone contact or video calls, will be excluded from the study.
结局指标
主要结局
Change from Asthma Control test (ACT) score at 6 months
时间窗: Applied in three moments: in beginning of the study, month 3, and month 6
The ACT is an important marker of the severity of the disease and parameter for determining the need to adjust the treatment plan.
Hospitalization rate and admissions to urgency/emergency services
时间窗: Collected at the end of the study (month 6)
The data will be made available by the Municipal Health Department
次要结局
- Change from Asthma Quality of Life Questionnaire (AQLQ) values at 6 months(Applied in two moments: in the beginning of the study and month 6)
研究者
Stella Pegoraro Alves Zarpelon
PhD candidate
Federal University of Rio Grande do Sul