RBR-9c3ssc Effect of telephone consultation associated with short messaging service (SMS) in patients with heart failure

Date of registration: 03/09/2018 ^(mm/dd/yyyy)
Last approval date : 03/09/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1210-5380

• Public title:

  en

  Effect of telephone consultation associated with short messaging service (SMS) in patients with heart failure

  pt-br

  Efeito da consulta por telefone associada ao short messaging service (SMS) em pacientes com insuficiência cardíaca

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 59724916.5.0000.5243
    Issuing authority: Plataforma Brasil
  • 1.901.574
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Medicina da Universidade Federal Fluminense

Sponsors

• Primary sponsor: Universidade Federal Fluminense
• Secondary sponsor:
  • Institution: Universidade Federal Fluminense
• Supporting source:
  • Institution: Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro - FAPERJ

Health conditions

• Health conditions:

  en

  Heart Failure

  pt-br

  Insuficiência Cardíaca

• General descriptors for health conditions:

  en

  C14 Cardiovascular diseases

  pt-br

  C14 Doenças cardiovasculares

  es

  C14 Enfermedades cardiovasculares

• Specific descriptors:

Interventions

• Interventions:

  en

  The methodology will use the randomized clinical trial, performed in two distinct parallel groups, being Intervention Group (IG) and Control Group (CG). The GI will consist of 60 patients with heart failure (HF) who, in addition to conventional treatment (multiprofessional consultation), will receive nursing intervention - a telephone consultation associated with a short message service (SMS), sending daily SMS and weekly telephone consultation . The CG will consist of 60 patients with HF who will receive conventional treatment. Will be compared the consultations interventions associated with short messaging service (SMS), with the conventional follow-up in outpatient care. Patients will be assessed on outpatient admission and after 90 days of intervention from the validated scales for use in Brazil.

  pt-br

  A metodologia utilizará o ensaio clínico randomizado, realizado em dois grupos paralelos distintos, sendo Grupo Intervenção (GI) e o Grupo Controle (GC). O GI será constituído de 60 pacientes com insuficiência caríaca (IC) que além do tratamento convencional (consulta multiprofissional), receberão intervenção de enfermagem - consulta telefônica associada a short message service (SMS), sendo o envio de SMS diário e a consulta telefônica semanal. O GC, será constituído de 60 pacientes com IC que receberão tratamento convencional. Serão comparadas as intervenções consulta associada com short messaging service (SMS), com o acompanhamento convencional em atendimento ambulatorial. Os pacientes serão avaliados na admissão ambulatorial e após 90 dias de intervenção a partir da aplicação das escalas validadas para uso no Brasil.

• Descriptors:

  en

  H02.403.840 Telemedicine

  pt-br

  H02.403.840 Telemedicina

  es

  H02.403.840 Telemedicina

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 06/01/2018 ^(mm/dd/yyyy)
• Date last enrollment: 07/01/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  120	-	18 Y	90 Y

• Inclusion criteria:

  en

  Patients older than 18 years; with medical diagnosis of HF, regardless of etiology; have face-to-face service with the multiprofessional team of the specialized IC clinic, since the telephone consultation and the SMS service work with the reinforcement of face-to-face orientations; preserved or diminished ejection fraction; functional class I-III (NYHA) and signing of the informed consent form.

  pt-br

  Pacientes maiores de 18 anos; com diagnóstico médico de IC, independente da etiologia; ter atendimento presencial com a equipe multiprofissional da clínica especializada em IC, pois a consulta telefônica e o serviço de SMS trabalham com o reforço das orientações presenciais; fração de ejeção preservada ou diminuída; classe funcional I-III (NYHA) e assinatura do termo de consentimento livre e esclarecido (TCLE).

• Exclusion criteria:

  en

  patients with cognitive neurological sequelae who did not have direct telephone contact

  pt-br

  pacientes com sequelas neurológicas cognitivas e que não possuíssem contato telefônico direto

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  Increased maintenance scores , management and self-care trust in heart failure analyzed at baseline and 90 days after the intervention by application of validated questionnaires in Brazi

  pt-br

  Aumento dos escores de manutenção, manejo e confiança do autocuidado em insuficiência cardíaca analisados no início do estudo e 90 dias após a intervenção através de aplicação de questionários validados no Brasil.

• Secondary outcomes:

  en

  Increased adherence scores to treatment and quality of life analyzed at baseline and 90 days after the intervention by application of validated questionnaires in Brazil.

  pt-br

  Aumento dos escores de adesão ao tratamento e qualidade de vida analisados no início do estudo e 90 dias após a intervenção através de aplicação de questionários validados no Brasil.

Contacts

• Public contact
  • Full name: Lyvia da Silva Figueiredo
  • • Address: Rua Dr Celestino, 74
    • City: Niterói / Brazil
    • Zip code: 24020-091
  • Phone: +55(21)2629-9464
  • Email: lyviafigueiredo@gmail.com
  • Affiliation: Universidade Federal Fluminense
   
• Scientific contact
  • Full name: Lyvia da Silva Figueiredo
  • • Address: Rua Dr Celestino, 74
    • City: Niterói / Brazil
    • Zip code: 24020-091
  • Phone: +55(21)2629-9464
  • Email: lyviafigueiredo@gmail.com
  • Affiliation: Universidade Federal Fluminense
   
• Site contact
  • Full name: Lyvia da Silva Figueiredo
  • • Address: Rua Dr Celestino, 74
    • City: Niterói / Brazil
    • Zip code: 24020-091
  • Phone: +55(21)2629-9464
  • Email: lyviafigueiredo@gmail.com
  • Affiliation: Universidade Federal Fluminense
   

Additional links:

• Download in ICTRP format