AsthmaEPETEFASNCT05055661
Pharmaceutical Teleconsultation in Adults With Asthma
A study testing Pharmaceutical Teleconsultation in people with Asthma, run by Federal University of Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Pharmaceutical Teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pragmatic Study of the Effectiveness of Pharmaceutical Teleconsultation in Adults With Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Pharmaceutical Teleconsultation
- Keywords
- Pragmatic Clinical Trial, Pharmaceutical Services, Telemedicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical TeleconsultationOther
The pharmacist will apply the teleconsultation according to the elaborated workflows and will follow in seven steps: scheduling the teleconsultation; pre-consultation, in which the pharmacist will make a checklist of the adequacy of the teleconsultation environment; presentation of the professional and the objectives of the teleconsultation to the patient; search for information about the patient and their pharmacotherapy; identification of problems related to pharmacotherapy; elaboration of a care plan and appointment for the re-consultation.
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | Patients randomized to the control group will receive health education, audiovisual educational meterial regarding the use of inhalers and inhalators spacers and be contacted throughout the six months to collect the study variables, by telephone contact. |
| The intervention group | Experimental | Patients randomized to the intervention grop will receive the same health education as the control group at the reference Basic Health Unit and also will be carried, once a month, the pharmaceutical teleconsultation during six months, by video call. The study variables will be collected in the same periods as the control group patients, by telephone contact. Receives: Other: Pharmaceutical Teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Asthma Control test (ACT) score at 6 months
The ACT is an important marker of the severity of the disease and parameter for determining the need to adjust the treatment plan.
Measured: Applied in three moments: in beginning of the study, month 3, and month 6
Hospitalization rate and admissions to urgency/emergency services
The data will be made available by the Municipal Health Department
Measured: Collected at the end of the study (month 6)
Secondary outcomes (1)
Change from Asthma Quality of Life Questionnaire (AQLQ) values at 6 months
Self-applicable, sent to patients by online form.
Measured: Applied in two moments: in the beginning of the study and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study startJun 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Stella Pegoraro Alves Zarpelon, Federal University of Rio Grande do Sul
- Investigators
- Denise Bueno, PhD, Principal investigator, Federal University of Rio Grande do SulStella Pegoraro Alves Zarpelon, MSc, Study director, Federal University of Rio Grande do SulDiogo Pilger, PhD, Study director, Federal University of Rio Grande do SulAline de Lima Nogare, MSc, Study chair, Federal University of Rio Grande do SulLuiza Fedatto Vidal, BSc, Study chair, Federal University of Rio Grande do SulFernando Kreutz, PhD, Study chair, Federal University of Rio Grande do SulLuciane Piva Klein, BSc, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055661
- Sponsor's protocol ID
- UFRGS EPETEFAS
- Acronym
- EPETEFAS
- Status last verified
- Apr 2023
- First submitted
- 3 Sep 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pizzichini MMM, Carvalho-Pinto RM, Cancado JED, Rubin AS, Cerci Neto A, Cardoso AP, Cruz AA, Fernandes ALG, Blanco DC, Vianna EO, Cordeiro Junior G, Rizzo JA, Fritscher LG, Caetano LSB, Pereira LFF, Rabahi MF, Oliveira MA, Lima MA, Almeida MB, Stelmach R, Pitrez PM, Cukier A. 2020 Brazilian Thoracic Association recommendations for the management of asthma. J Bras Pneumol. 2020 Mar 2;46(1):e20190307. doi: 10.1590/1806-3713/e20190307. eCollection 2020.
PubMed 32130345Erdmann AL, de Andrade SR, de Mello AL, Drago LC. Secondary health care: best practices in the health services network. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:131-9. doi: 10.1590/s0104-11692013000700017. English, Portuguese.
PubMed 23459900Alexander E, Butler CD, Darr A, Jenkins MT, Long RD, Shipman CJ, Stratton TP. ASHP Statement on Telepharmacy. Am J Health Syst Pharm. 2017 May 1;74(9):e236-e241. doi: 10.2146/ajhp170039. No abstract available.
PubMed 28438829Niznik JD, He H, Kane-Gill SL. Impact of clinical pharmacist services delivered via telemedicine in the outpatient or ambulatory care setting: A systematic review. Res Social Adm Pharm. 2018 Aug;14(8):707-717. doi: 10.1016/j.sapharm.2017.10.011. Epub 2017 Oct 28.
PubMed 29100941Parreiras Martins MA, Fonseca de Medeiros A, Dias Carneiro de Almeida C, Moreira Reis AM. Preparedness of pharmacists to respond to the emergency of the COVID-19 pandemic in Brazil: a comprehensive overview. Drugs Ther Perspect. 2020;36(10):455-462. doi: 10.1007/s40267-020-00761-7. Epub 2020 Jul 31.
PubMed 32837194Coutinho Eda S, Huf G, Bloch KV. [Pragmatic clinical trials: an option in the construction of health-related evidence]. Cad Saude Publica. 2003 Jul-Aug;19(4):1189-93. doi: 10.1590/s0102-311x2003000400039. Epub 2003 Sep 8. Portuguese.
PubMed 12973582Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.
PubMed 1549827Franco R, Nascimento HF, Cruz AA, Santos AC, Souza-Machado C, Ponte EV, Souza-Machado A, Rodrigues LC, Barreto ML. The economic impact of severe asthma to low-income families. Allergy. 2009 Mar;64(3):478-83. doi: 10.1111/j.1398-9995.2009.01981.x. Epub 2009 Feb 6.
PubMed 19210355Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
PubMed 14713908Roxo JP, Ponte EV, Ramos DC, Pimentel L, D'Oliveira Junior A, Cruz AA. [Portuguese-language version of the Asthma Control Test]. J Bras Pneumol. 2010 Mar-Apr;36(2):159-66. doi: 10.1590/s1806-37132010000200002. Portuguese.
PubMed 20485935
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Study of the Effectiveness of Pharmaceutical Teleconsultation in Adults With Asthma
- ClinicalTrials.gov ID
- NCT05055661
- Acronym / sponsor ID
- EPETEFAS / UFRGS EPETEFAS
- Conditions
- Asthma
- Keywords
- Pragmatic Clinical Trial, Pharmaceutical Services, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –Patients randomized to the control group will receive health education, audiovisual educational meterial regarding the use of inhalers and inhalators spacers and be contacted throughout the six months to collect the study variables, by telephone contact. |
| The intervention group | Experimental | Other: Pharmaceutical TeleconsultationPatients randomized to the intervention grop will receive the same health education as the control group at the reference Basic Health Unit and also will be carried, once a month, the pharmaceutical teleconsultation during six months, by video call. The study variables will be collected in the same periods as the control group patients, by telephone contact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical TeleconsultationThe pharmacist will apply the teleconsultation according to the elaborated workflows and will follow in seven steps: scheduling the teleconsultation; pre-consultation, in which the pharmacist will make a checklist of the adequacy of the teleconsultation environment; presentation of the professional and the objectives of the teleconsultation to the patient; search for information about the patient and their pharmacotherapy; identification of problems related to pharmacotherapy; elaboration of a care plan and appointment for the re-consultation. | Other | The intervention group |
Primary outcome
Change from Asthma Control test (ACT) score at 6 months
Time frame: 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
Time frame: Collected at the end of the study (month 6)
The data will be made available by the Municipal Health Department
1 secondary outcome
Change from Asthma Quality of Life Questionnaire (AQLQ) values at 6 months
Time frame: Applied in two moments: in the beginning of the study and month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 32130345Pizzichini MMM, Carvalho-Pinto RM, Cancado JED, Rubin AS, Cerci Neto A, Cardoso AP, Cruz AA, Fernandes ALG, Blanco DC, Vianna EO, Cordeiro Junior G, Rizzo JA, Fritscher LG, Caetano LSB, Pereira LFF, Rabahi MF, Oliveira MA, Lima MA, Almeida MB, Stelmach R, Pitrez PM, Cukier A. 2020 Brazilian Thoracic Association recommendations for the management of asthma. J Bras Pneumol. 2020 Mar 2;46(1):e20190307. doi: 10.1590/1806-3713/e20190307. eCollection 2020.
- Background: PubMed 23459900Erdmann AL, de Andrade SR, de Mello AL, Drago LC. Secondary health care: best practices in the health services network. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:131-9. doi: 10.1590/s0104-11692013000700017. English, Portuguese.
- Background: PubMed 28438829Alexander E, Butler CD, Darr A, Jenkins MT, Long RD, Shipman CJ, Stratton TP. ASHP Statement on Telepharmacy. Am J Health Syst Pharm. 2017 May 1;74(9):e236-e241. doi: 10.2146/ajhp170039. No abstract available.
- Background: PubMed 29100941Niznik JD, He H, Kane-Gill SL. Impact of clinical pharmacist services delivered via telemedicine in the outpatient or ambulatory care setting: A systematic review. Res Social Adm Pharm. 2018 Aug;14(8):707-717. doi: 10.1016/j.sapharm.2017.10.011. Epub 2017 Oct 28.
- Background: PubMed 32837194Parreiras Martins MA, Fonseca de Medeiros A, Dias Carneiro de Almeida C, Moreira Reis AM. Preparedness of pharmacists to respond to the emergency of the COVID-19 pandemic in Brazil: a comprehensive overview. Drugs Ther Perspect. 2020;36(10):455-462. doi: 10.1007/s40267-020-00761-7. Epub 2020 Jul 31.
- Background: PubMed 12973582Coutinho Eda S, Huf G, Bloch KV. [Pragmatic clinical trials: an option in the construction of health-related evidence]. Cad Saude Publica. 2003 Jul-Aug;19(4):1189-93. doi: 10.1590/s0102-311x2003000400039. Epub 2003 Sep 8. Portuguese.
- Background: PubMed 1549827Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.
- Background: PubMed 19210355Franco R, Nascimento HF, Cruz AA, Santos AC, Souza-Machado C, Ponte EV, Souza-Machado A, Rodrigues LC, Barreto ML. The economic impact of severe asthma to low-income families. Allergy. 2009 Mar;64(3):478-83. doi: 10.1111/j.1398-9995.2009.01981.x. Epub 2009 Feb 6.
- Background: PubMed 14713908Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
- Background: PubMed 20485935Roxo JP, Ponte EV, Ramos DC, Pimentel L, D'Oliveira Junior A, Cruz AA. [Portuguese-language version of the Asthma Control Test]. J Bras Pneumol. 2010 Mar-Apr;36(2):159-66. doi: 10.1590/s1806-37132010000200002. Portuguese.
- Global Initiative for Asthma. Global Strategy for Asthma Management and PreventionLink provided by the sponsor.
- Brazil, Ministry of Health. Resolution No. 466. Provides for guidelines and regulatory standards for research involving human beingsLink provided by the sponsor.
- General Law for the Protection of Personal Data (LGPD), BrazilLink provided by the sponsor.
- Brazil, Ministry of Health. Circular Letter No. 2. Guidelines for research procedures at any stage in a virtual environmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Bueno, PhD principal investigator
Federal University of Rio Grande do Sul
Stella Pegoraro Alves Zarpelon, MSc study director
Federal University of Rio Grande do Sul
Diogo Pilger, PhD study director
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical Teleconsultation in people with Asthma, run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Bueno, PhD (555133082106, denise.bueno@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Asthma Control test (ACT) score at 6 months (time frame: Applied in three moments: in beginning of the study, month 3, and month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055661, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.