Clinical trial NCT05055661: Pharmaceutical Teleconsultation in Adults With Asthma
Official title: Pragmatic Study of the Effectiveness of Pharmaceutical Teleconsultation in Adults With Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Pragmatic Clinical Trial
Pharmaceutical Services
Telemedicine
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2021-09-24
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Patients considered for the study must meet the following inclusion criteria: diagnosis of asthma, age equal to or greater than 18 years old, ACT scores below 20 points, agree to participate in the teleservice and acceptance by written or audio message, from the informed consent. Patients who do not attend the research team in the foreseen contacts and patients with cognitive problems will be excluded from the study.

Patients will be randomized, using specific software, to one of two groups: control group (Health education) or intervention group (Pharmaceutical teleconsultation). The research team will accompany the participants of both groups for six months by remote, telephone contact, and video call, using Google Meet® or Whatsapp®.

The population considers all patients diagnosed with asthma followed at the municipal primary health care network. Thus, the patient sample size needed to obtain 1-α = 0.95 confidence, and ε = 7% maximum error was estimated for a minimum of 196 patients (98 patients in each group), estimating 80% power to detect a difference of 0.1 between the proportion of the null hypothesis and the alternative hypothesis. With expected losses of 25%, the sample was increased to 123 individuals in each group, totaling 246 patients.

The chi-square test for categorical variables and the t-student test for continuous characteristics will be applied to compare the baseline characteristics between control and intervention groups. The variables compared will be related to the clinical and humanistic outcomes observed, based on the ACT score, indicating the effective control of asthma. The hypothesis tests will identify significant differences between individuals for the analysis of results, adopting a significance level of 0.05. Data analysis will follow an intention-to-treat analysis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Asthma Control test (ACT) score at 6 months
timeFrame: Applied in three moments: in beginning of the study, month 3, and month 6
measure: Hospitalization rate and admissions to urgency/emergency services
timeFrame: Collected at the end of the study (month 6)
Secondary outcomes:
measure: Change from Asthma Quality of Life Questionnaire (AQLQ) values at 6 months
timeFrame: Applied in two moments: in the beginning of the study and month 6
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Denise Bueno, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Stella Pegoraro Alves Zarpelon, MSc
role: STUDY_DIRECTOR
affiliation: Federal University of Rio Grande do Sul
name: Diogo Pilger, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Rio Grande do Sul
name: Aline de Lima Nogare, MSc
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Luiza Fedatto Vidal, BSc
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Fernando Kreutz, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Luciane Piva Klein, BSc
role: STUDY_CHAIR
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