RBR-92z99d2 Strategy for increase vaccine coverage for influenza in diabetic patients at a tertiary university hospital - a randomiz...

Date of registration: 01/07/2022 ^(mm/dd/yyyy)
Last approval date : 01/07/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1270-5536

• Public title:

  en

  Strategy for increase vaccine coverage for influenza in diabetic patients at a tertiary university hospital - a randomized clinical trial

  pt-br

  Estratégia para aumento de cobertura vacinal para influenza em pacientes diabéticos de um hospital universitário terciário – um ensaio clínico randomizado

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 02024018.5.0000.5346
    Issuing authority: Plataforma Brasil
  • 3.049.370
    Issuing authority: Parecer do Comitê de Ética em Pesquisa da Universidade Federal de Santa Maria (UFSM)

Sponsors

• Primary sponsor: Universidade Federal de Santa Maria (UFSM)
• Secondary sponsor:
  • Institution: Universidade Federal de Santa Maria (UFSM)
• Supporting source:
  • Institution: Universidade Federal de Santa Maria (UFSM)

Health conditions

• Health conditions:

  en

  Human Influenza

  pt-br

  Influenza Humana

• General descriptors for health conditions:

  en

  C18.452.394.750 Diabetes Mellitus

  pt-br

  C18.452.394.750 Diabetes Mellitus

• Specific descriptors:

  en

  C01.748.310;C01.925.782.620.365;C08.730 Influenza, Human

  pt-br

  C01.748.310;C01.925.782.620.365;C08.730 Influenza Humana

Interventions

• Interventions:

  en

  Experimental group: 102 diabetic patients received a phone call before the 2020 influenza vaccine campaign for influenza, in order to advise on the need to update influenza, MMR, pneumonia and hepatitis B vaccines. A standard text was spoken in this guideline for all patients in this group. After the vaccination campaign for the year 2020, patients received a new phone call in order to find out if they had received the vaccines. Control group: 103 diabetic patients received a phone call after the 2020 vaccine campaign, in order to find out if they had received the vaccines.

  pt-br

  Grupo experimental: 102 pacientes diabéticos receberam uma ligação telefônica antes da campanha vacinal do ano de 2020 para influenza, com a finalidade de orientar sobre a necessidade de atualização das vacinas influenza, tríplice bacteriana, pneumonia e hepatite B. Um texto padrão foi falado nesta orientação para todos os pacientes deste grupo. Passada a campanha vacinal do ano de 2020, os pacientes, receberam uma nova ligação telefônica com a finalidade de saber se realizaram as vacinas. Grupo controle: 103 pacientes diabéticos receberam uma ligação telefônica após a campanha vacina do ano de 2020, com a finalidade de saber se realizaram as vacinas.

• Descriptors:

  en

  L01.178.847.698;SP2.021.167.010.080 Telephone

  pt-br

  L01.178.847.698;SP2.021.167.010.080 Telefone

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 12/01/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  205	-	0	0

• Inclusion criteria:

  en

  Individuals of both sexes and of any age; diagnosed with diabetes mellitus of any etiology; who were treated at the endocrinology, metabolism, pediatric endocrinology and internal medicine clinics of the University Hospital of Santa Maria; patients who had this diagnosis recorded in their medical records or who were using insulin or oral antidiabetics were considered diabetic

  pt-br

  Indivíduos de ambos os sexos e de qualquer idade; com diagnóstico de diabetes mellitus de qualquer etiologia; que foram atendidos nos ambulatórios de endocrinologia, metabolismo, endocrinologia pediátrica e medicina interna do Hospital Universitário de Santa Maria; foram considerados diabéticos os pacientes que apresentaram registro deste diagnóstico em prontuário ou que estivessem em uso de insulina ou antidiabéticos orais

• Exclusion criteria:

  en

  Diagnosis of gestational diabetes mellitus; Presence of any contraindication to flu vaccination reported by the patient or recorded in the medical record, such as allergy to formula components

  pt-br

  Diagnóstico de diabetes mellitus gestacional; Presença de qualquer contraindicação à vacinação para gripe referida pelo paciente ou registrada em prontuário, como alergia aos componentes da fórmula

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Prevention	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Greater vaccination coverage of the research subjects, carried out through a telephone call to check if the subjects were vaccinated (participated) in the 2020 vaccination campaign.

  pt-br

  Maior cobertura vacinal dos sujeitos da pesquisa, avaliada através de ligação telefônica para verificar se os sujeitos se vacinaram (participaram) da campanha vacinal de 2020.

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Tiango Aguiar Ribeiro
  • • Address: Avenida Guilherme Kurtz 4825,
    • City: Itaara / Brazil
    • Zip code: 97185-000
  • Phone: +55 55 991275091
  • Email: tiangoribeiro@gmail.com
  • Affiliation:
   
• Scientific contact
  • Full name: Tiango Aguiar Ribeiro
  • • Address: Avenida Guilherme Kurtz 4825,
    • City: Itaara / Brazil
    • Zip code: 97185-000
  • Phone: +55 55 991275091
  • Email: tiangoribeiro@gmail.com
  • Affiliation:
   
• Site contact
  • Full name: Giulia Limana Guerra
  • • Address: Av. Roraima nº 1000, Departamento de Cirurgia
    • City: Santa Maria / Brazil
    • Zip code: 97105-900
  • Phone: +5555996579692
  • Email: giulialimanaguerra@gmail.com
  • Affiliation:
   

Additional links:

• Download in ICTRP format