NCT03214965

Brief Summary

This study is designed to compare the knowledge, satisfaction and self-esteem of kidney transplanted adolescents measured through questionnaires between two groups: patients undergoing conventional treatment with no other intervention versus patients undergoing conventional treatment and receiving additional educational and consultative actions using a closed facebook group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

September 19, 2016

Last Update Submit

July 18, 2017

Conditions

Kidney TransplantationEducation

Keywords

Kidney transplantationFacebookEducationAdolescentSocial Networking

Outcome Measures

Primary Outcomes (3)

  • Knowledge about the disease

    Knowledge about the disease and associated conditions measured by a specific designed questionnaire.

    3 months

  • Satisfaction about the treatment

    Satisfaction with the interdisciplinary team obtained by a specific designed questionnaire

    3 months

  • Self-esteem

    Assessment of the participant's self-esteem through the application of the "Rosenberg's Self-Esteem Scale"

    3 months

Study Arms (2)

Facebook group

ACTIVE COMPARATOR

Patients of the kidney transplantation group randomly assigned to be part of a closed facebook group.

Behavioral: Facebook group

Control group

NO INTERVENTION

Patients of the kidney transplantation group that do not receive specific educational interventions.

Interventions

Facebook groupBEHAVIORAL

A closed facebook group used to deliver multimedia content specifically produced to inform the participants about chronic kidney disease, kidney transplantation and related topics. This group is also used to share doubts and life experiences among participants and the interdisciplinary team.

Facebook group

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients receiving follow up care by the transplant interdisciplinary team either in the pre or in the post transplant period

You may not qualify if:

  • patients with chronic kidney disease not enrolled to receive a kidney transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital da Criança Santo Antônio da Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, 90240-510, Brazil

Location

Related Publications (31)

  • Sesso, R. Epdemiologia da doença renal crônica no Brasil. Guia de Nefrologia. São Paulo: Manole; 2002.

    BACKGROUND

  • Garcia, VD, Pacheco, L. Revista Brasileira de transplantes: Dimensionamento dos transplantes no Brasil e em cada estado. Ano XX n. 4. 2014.

    BACKGROUND

  • Lira ALBC, Guedes MVC, Lopes MVO. Adaptação psicossocial do adolescente pós-transplante renal segundo a teoria de roy. Invest Educ Enferm. 2005; 23;1: 68-77.

    BACKGROUND

  • Morales LC, Castilho E. Vivencias de los(as) adolescentes en diálisis: una vida con múltiples pérdidas pero con esperanza. Colombia Médica. 2007; 38; 4: 44-53.

    BACKGROUND

  • Pereira L M. Adesão ao tratamento imunossupressor no transplante renal. São Paulo: Permanyer Brasil Publicações, Ltda; 2012.

    BACKGROUND

  • Garcez JLAF, Maciel FR, Cardoso VMB. Considerações ergonômicas para aplicação de mídia em ambientes educacionais para crianças de ensino fundamental. Produção. 2012; 22; 2: 284-295.

    BACKGROUND

  • Vitola, SP. Transplante renal em crianças com peso inferior a 15 Kg; acesso cirúrgico extraperitoneal- Experiência em 62 transplantes. [Tese]. Porto Alegre: Pós-graduação em Ciências Cirúgicas da Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, 2011.

    BACKGROUND

  • Casas RV. Transplante renal pediátrico. Enero, 2003; 59; 1460, 24-30.

    BACKGROUND

  • Garcia CD, Bittencourt VB, Rohde RW, Vitola SP. Transplante renal pediátrico. in: Garcia CD, Pereira JD, Zago MK, Garcia VD. Manual de doação e transplantes. 1.ed. Rio de Janeiro: Elsevier; 2013. p. 225-234.

    BACKGROUND

  • Goldani JC, Vitola SP, Souza LV, Souza LVB. Transplante renal. In: Garcia CD, Pereira JD, Zago MK, Garcia VD. Manual de doação e transplantes. 1.ed, Rio de Janeiro: Elsevier; 2013. p. 193-198.

    BACKGROUND

  • Matas AJ. Impacto de não-adesão do receptor nos desfechos em longo prazo de transplante. Revisão da literatura e experiência da universidade de Minnesola. Bras. Transpl. 2007; 828-831.

    BACKGROUND

  • Nifa S, Rudnicki T. Depressão em pacientes Renais Crônicos em tratamento de Hemodiálise. Rev SBPH. 2010; 13; 1.

    BACKGROUND

  • Brasil, Secretaria da Saúde. Manual de atenção à saúde do adolescente/ Secretaria da Saúde. Coordenação de Desenvolvimento de Programas e Políticas de Saúde- CODEPPS. São Paulo: SMS, 2006. 328p

    BACKGROUND

  • Marciano RC. Transtornos mentais e qualidade de vida em crianças e adolescentes com doença renal crônica em seus cuidadores.[dissertação]. Minas Gerais: Pós-graduação da Faculdade de Medicina da UFMG, 2009.

    BACKGROUND

  • Christensen CM. Inovação na gestão da saúde: soluções disruptivas para reduzir custos e aumentar qualidade. Porto Alegre: Bookman, 2009. 422p.

    BACKGROUND

  • Stoltz T. Mídia, cognição e educação. Educar. 2005; 26; 147-156.

    BACKGROUND

  • Garcez JLAF, Maciel FR, Cardoso VMB. Considerções ergonômicas para aplicação de mídia em ambientes educacionais para crianças de ensino fundamental. Produção. 2012; 22; 2. 284-295.

    BACKGROUND

  • Lenhart A. Teens and Mobile Phones. Pew Internet & American Life Project. 2010.

    BACKGROUND

  • Nielsen. Social media comes of age. Retrieved May 2 2013 from <http://www.nielsen.com/us/en/newswire/2012/social-media-report-2012-social-media-comes-of-age.html>.

    BACKGROUND

  • Barbosa SM, Dias FLA, Pinheiro AKB, Pinheiro PNC, Vieira NFC. Jogo educativo como estratégia de educação em saúde para adolescentes na prevenção às DST/AIDS. Rev. Eletr. Enf. 2010; 12; 2. 337-41.

    BACKGROUND

  • Ellison N, Steinfield C, Lampe C. The Benefits of Facebook ''Friends:'' Social Capital and College Students' Use of Online Social Network Sites. Journal of Computer-Mediated Communication. 2007; 12. 1143-1168.

    BACKGROUND

  • Brasil. Ministério da Saúde. Conselho Nacional de Saúde. Resolução 196/96, de 10 de Outubro de 1996. Dispõe sobre as diretrizes e normas regulamentadoras de pesquisa envolvendo seres humanos. Brasília, 1996.

    BACKGROUND

  • Gamonar F. A morte dos Shoppings, o fim do fecebook e o futuro criado pelos millennials. 2015. https://www.linkedin.com/pulse/morte-dos-shoppings-o-fim-do-facebook-e-futuro-criado-flavia-gamonar. Visualizado dia: 14/02/16.

    BACKGROUND

  • Carmo EH, Barreto ML, Silva JBJ. Mudanças nos padrões de morbimortalidade da populaçãoo brasileira: os desafios para um novo século. Epidemiol. Serv. Saúde. 2003; 12. 2. 63-75.

    BACKGROUND

  • Randomization.com [internet]. Available in:http:// www.randomization.com

    BACKGROUND

  • Dini GM, Quaresma MR, Ferreira LM. Adaptação cultural e validaçãoo da versão Brasileira da Escala de Auto-estima de Rosenberg.Rev. Soc. Bras. Cir. Plast. 2004; 19. 1. 41-52.

    BACKGROUND

  • Rosenberg M. Society and the adolescente self image. Princeton: Princeton university Press; 1965.

    BACKGROUND

  • Noronha IL, Ferraz AS, Silva AP Filho, Saitovich D, Carvalho DBM, Paula FJ, Campos H, Lanhez LE, Garcia VD. Transplante Renal: Doador e Receptor. Projeto Diretrizes Associação Médica Brasileira e Conselho Federal de Medicina. 1-19.

    BACKGROUND

  • Oliva M, Singh TP, Gauvreau K, Vanderpluym CJ, Bastardi HJ, Almond CS. Impact of medication non-adherence on survival after pediatric heart transplantation in the U.S.A. J Heart Lung Transplant. 2013 Sep;32(9):881-8. doi: 10.1016/j.healun.2013.03.008. Epub 2013 Jun 4.

    PMID: 23755899RESULT

  • Takemoto SK, Pinsky BW, Schnitzler MA, Lentine KL, Willoughby LM, Burroughs TE, Bunnapradist S. A retrospective analysis of immunosuppression compliance, dose reduction and discontinuation in kidney transplant recipients. Am J Transplant. 2007 Dec;7(12):2704-11. doi: 10.1111/j.1600-6143.2007.01966.x. Epub 2007 Sep 14.

    PMID: 17868065RESULT

  • Pase C, Mathias AD, Garcia CD, Garcia Rodrigues C. Using Social Media for the Promotion of Education and Consultation in Adolescents Who Have Undergone Kidney Transplant: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2018 Jan 9;7(1):e3. doi: 10.2196/resprot.8065.

    PMID: 29317381DERIVED

Study Officials

  • Silvia Goldmeier, PhD

    Fundação Instituto de Cardiologia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are assigned to participate into one of two groups (control group or intervention group) in parallel for the duration of the study. The control group receives no form of intervention or education. The intervention group participates into a closed facebook group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

September 19, 2016

First Posted

July 12, 2017

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

No IPD will be shared among other researchers.

Locations

BR(1)