RBR-2jpr96k Impact of the use of mobile applications in the treatment of patients in hemodialysis - randomized clinical trial

Date of registration: 07/12/2023 ^(mm/dd/yyyy)
Last approval date : 07/12/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1288-4070

• Public title:

  en

  Impact of the use of mobile applications in the treatment of patients in hemodialysis - randomized clinical trial

  pt-br

  Impacto do uso de aplicativo móvel no tratamento de pacientes em hemodiálise - ensaio clínico randomizado

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 3124.6220.1.0000.5191
    Issuing authority: Plataforma Brasil
  • 4.044.382
    Issuing authority: Comitê de Ética em Pesquisa do Centro Integrado de Saúde Amaury de Medeiros

Sponsors

• Primary sponsor: Fundação Universidade de Pernambuco
• Secondary sponsor:
  • Institution: Fundação Universidade de Pernambuco
• Supporting source:
  • Institution: Fundação Universidade de Pernambuco

Health conditions

• Health conditions:

  en

  Kidney Failure Chronic; Adherence to Treatment

  pt-br

  Doença Renal Crônica; Aderência ao Tratamento

• General descriptors for health conditions:

  en

  C12.050.351.968.419 Nephropathies

  pt-br

  C12.050.351.968.419 Nefropatias

• Specific descriptors:

  en

  C12.050.351.968.419.780.750 Chronic Kidney Disease

  pt-br

  C12.050.351.968.419.780.750 Doença Renal Crônica

  en

  F01.100.150.750 Adherence to Treatment

  pt-br

  F01.100.150.750 Aderência ao Tratamento

Interventions

• Interventions:

  en

  Initially, the randomization of the control and intervention groups was carried out through the randomize.com program. The researcher responsible for randomization will not participate in data collection and the researchers who were collecting the measurement instruments were blind. The Intervention Group consisted of 70 patients who are using the Renal Health application during the 4-month period. During this period, they were receiving information and guidelines for use by the research team specifically for this purpose. The Control Group, composed of 70 patients, continued with the routine assistance of the dialysis clinic, in which the use of a mobile application is not included.

  pt-br

  Inicialmente foi realizado a randomização dos grupos controle e intervenção através do programa randomize.com.O pesquisador responsável pela randomização não participará da coleta de dados e os pesquisadores que estavam na coleta dos instrumentos de medida estavam cegos. O Grupo Intervenção foi composto por 70 pacientes que estão utilizando o aplicativo renal Health durante o período de 4 meses. Durante esse período eles estavam recebendo informações e orientações de uso da equipe de pesquisa específica para este fim. O Grupo Controle, composto por 70 pacientes, seguiu com a assistência de rotina da clinica de diálise, a qual o uso de aplicativo móvel não está incluso

• Descriptors:

  en

  L01.224.230.260.550.500.750 Smartphone

  pt-br

  L01.224.230.260.550.500.750 Smartphone

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 03/01/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  140	-	18 Y	0

• Inclusion criteria:

  en

  Patients who have been undergoing treatment for at least three months, who understand Portuguese, have a smartphone and know how to handle it

  pt-br

  Pacientes os quais estejam realizando o tratamento há no mínimo três meses; que compreendam a língua portuguesa que possuam smartphone e saibam manuseá-lo

• Exclusion criteria:

  en

  Patients with advanced stage dementia indicated in the medical record, including Parkinson's and Alzheimer's disease, and significant cognitive impairment; Patients with hearing and visual impairment; Patients undergoing hemodialysis temporarily at the study site

  pt-br

  Portadores de doenças demenciais em estágio avançado indicado no prontuário, incluindo doença de Parkinson e Alzheimer, e déficit cognitivo importante; Pacientes com deficiência auditiva e visual; Pacientes realizando hemodiálise temporariamente no local do estudo

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  It is expected that the use of the application will improve adherence to the proposed treatment evaluated through Study instrument: Assessment questionnaire on adherence of patients with chronic kidney disease on hemodialysis (QADRC-HD), which is applied and their scores are compared before and after the interventions.

  pt-br

  Espera-se que o uso do aplicativo melhore a adesão ao tratamento proposto avaliada através Instrumento de estudo: Questionário de avaliação sobre a adesão do portador de doença renal crônica em hemodiálise (QADRC-HD) o qual é aplicado e comparado seus escores antes e após as intervenções.

• Secondary outcomes:

  en

  The health-related quality of life assessed through the Kidney Disease and Quality-of-Life Short-Form Study Instrument (KDQOL-SF) is expected to be higher after using the application

  pt-br

  Espera-se que a qualidade de vida relacionada a saúde avaliada através Instrumento de estudo Kidney Disease and Quality-of-Life Short-Form (KDQOL-SF) seja maior após o uso do aplicativo

Contacts

• Public contact
  • Full name: Christielle Lidianne Alencar Marinho
  • • Address: Alameda das Orquídeas, 151, Cidade Universitária
    • City: Petrolina / Brazil
    • Zip code: 56332-764
  • Phone: +55-087-996296477
  • Email: cmarinho@uneb.br
  • Affiliation: Universidade de Pernambuco
   
• Scientific contact
  • Full name: Christielle Lidianne Alencar Marinho
  • • Address: Alameda das Orquídeas, 151, Cidade Universitária
    • City: Petrolina / Brazil
    • Zip code: 56332-764
  • Phone: +55-087-996296477
  • Email: cmarinho@uneb.br
  • Affiliation: Universidade de Pernambuco
   
• Site contact
  • Full name: Christielle Lidianne Alencar Marinho
  • • Address: Alameda das Orquídeas, 151, Cidade Universitária
    • City: Petrolina / Brazil
    • Zip code: 56332-764
  • Phone: +55-087-996296477
  • Email: cmarinho@uneb.br
  • Affiliation: Universidade de Pernambuco
   

Additional links:

• Download in ICTRP format