RBR-95smwv Social Support

Date of registration: 12/27/2018 ^(mm/dd/yyyy)
Last approval date : 12/27/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1221-9218

• Public title:

  en

  Social Support

  pt-br

  Suporte Social

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 12622413.6.0000.5060
    Issuing authority: Plataforma Brasil
  • 242.831
    Issuing authority: Comite de Etica em Pesquisa do Centro de Ciencias da Saude - Universidade Federal do Espírito Santo

Sponsors

• Primary sponsor: Conselho Nacional de Pesquisas
• Secondary sponsor:
  • Institution: Universidade Federal do Espirito Santo
• Supporting source:
  • Institution: Conselho Nacional de Pesquisas

Health conditions

• Health conditions:

  en

  Tuberculosis Societies

  pt-br

  Associações de Combate a tuberculose

• General descriptors for health conditions:

  en

  C23 Pathological conditions, signs and symptoms

  pt-br

  C23 Condições patológicas, sinais e sintomas

  es

  C23 Condiciones patológicas, signos y síntomas

• Specific descriptors:

Interventions

• Interventions:

  en

  Experimental group: 240 individuals with tuberculosis received a basic food basket with non-perishable food. The basic food baskets were offered in the units previously selected for intervention throughout the treatment of the patient. It is necessary to obtain the basic basket the participation in the monthly consultation of the patient in the health service. Control group: 646 individuals with tuberculosis were monitored monthly only with drug treatment.

  pt-br

  Grupo experimental: 240 indivíduos com tuberculose receberam uma cesta básica com alimentos não perecíveis. As cestas básicas de alimento foram oferecidas nas unidades previamente selecionadas para intervenção durante todo o tratamento do paciente. Sendo necessário para a obtenção da cesta básica a participação na consulta mensal de acompanhamento do paciente no serviço de saúde. Grupo controle: 646 indivíduos com tuberculose foram acompanhados mensalmente apenas com tratamento medicamentoso.

• Descriptors:

  en

  I01.655.500.608 Public Policy

  pt-br

  I01.655.500.608 Política Pública

  es

  I01.655.500.608 Política Pública

Recruitment

• Study status: Other
• Countries
  • Brazil
• Date first enrollment: 03/21/2014 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  886	-	18 Y	0 -

• Inclusion criteria:

  en

  Patients over 18 years of age, being diagnosed   with tuberculosis.

  pt-br

  Pacientes maiores de 18 anos; ser diagnosticado com tuberculose.

• Exclusion criteria:

  en

  Individuals with multidrug-resistant tuberculosis, transferred from other health facilities for more than 15 days.

  pt-br

  Indivíduos com tuberculose multirresistente, transferidos de outras unidades de saúde há mais de 15 dias.

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  difference in number of patients who adhered to the treatment of tuberculosis and cure, verified by the follow-up of the patients and the finding of at least 5% increase in the success rate to the treatment with the intervention.

  pt-br

  Diferença no número de pacientes que aderiram ao tratamento da tuberculose e curaram, verificado pelo acompanhamento dos pacientes e com a constatação de pelo menos 5% de aumento na taxa de sucesso ao tratamento com a intervenção.

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Ethel Leonor Noia Maciel
  • • Address: Avenida Fernando Ferrari, 514, Goiabeiras
    • City: Vitoria / Brazil
    • Zip code: 29075-910
  • Phone: +55-027-33357013
  • Email: ethel.maciel@gmail.com
  • Affiliation: Universidade Federal do Espirito Santo
   
• Scientific contact
  • Full name: Ethel Leonor Noia Maciel
  • • Address: Avenida Fernando Ferrari, 514, Goiabeiras
    • City: Vitoria / Brazil
    • Zip code: 29075-910
  • Phone: +55-027-33357013
  • Email: ethel.maciel@gmail.com
  • Affiliation: Universidade Federal do Espirito Santo
   
• Site contact
  • Full name: Ethel Leonor Noia Maciel
  • • Address: Avenida Fernando Ferrari, 514, Goiabeiras
    • City: Vitoria / Brazil
    • Zip code: 29075-910
  • Phone: +55-027-33357013
  • Email: ethel.maciel@gmail.com
  • Affiliation: Universidade Federal do Espirito Santo
   

Additional links:

• Download in ICTRP format