Pharmaceutical Teleconsultation in Adults With Asthma

NCT05055661 | Unknown

• 1 other identifier: UFRGS EPETEFAS
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Pragmatic Clinical Trial; Pharmaceutical Services; Telemedicine

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Collected at the end of the study (month 6)

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

Other: Pharmaceutical Teleconsultation

Interventions

Pharmaceutical Teleconsultation OTHER

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.

The intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Related Publications (10)

• 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.

  PMID: 32130345 BACKGROUND

• Erdmann 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.

  PMID: 23459900 BACKGROUND

• Alexander 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.

  PMID: 28438829 BACKGROUND

• Niznik 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.

  PMID: 29100941 BACKGROUND

• Parreiras 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.

  PMID: 32837194 BACKGROUND

• Coutinho 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.

  PMID: 12973582 BACKGROUND

• Juniper 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.

  PMID: 1549827 BACKGROUND

• Franco 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.

  PMID: 19210355 BACKGROUND

• Nathan 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.

  PMID: 14713908 BACKGROUND

• Roxo 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.

  PMID: 20485935 BACKGROUND

Related Links

• Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention
• Brazil, Ministry of Health. Resolution No. 466. Provides for guidelines and regulatory standards for research involving human beings
• General Law for the Protection of Personal Data (LGPD), Brazil
• Brazil, Ministry of Health. Circular Letter No. 2. Guidelines for research procedures at any stage in a virtual environment

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Denise Bueno, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Stella Pegoraro Alves Zarpelon, MSc

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

• Diogo Pilger, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

• Aline de Lima Nogare, MSc

  Federal University of Rio Grande do Sul

  STUDY CHAIR

• Luiza Fedatto Vidal, BSc

  Federal University of Rio Grande do Sul

  STUDY CHAIR

• Fernando Kreutz, PhD

  Federal University of Rio Grande do Sul

  STUDY CHAIR

• Luciane Piva Klein, BSc

  Federal University of Rio Grande do Sul

  STUDY CHAIR

Central Study Contacts

Denise Bueno, PhD

CONTACT

555133082106; denise.bueno@ufrgs.br

Stella Pegoraro Alves Zarpelon, MSc

CONTACT

5551999834904; stellape@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 24, 2021
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share