AzTrials
AzTrials

Kidney TransplantationNCT03214965

The Use of the Social Networking to Promote Educational and Consultative Actions Among Kidney Transplanted Adolescents.

A study testing Facebook group in people with Kidney Transplantation and Education, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Kidney Transplantation, Education
What is being tested?
Facebook group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteBrazil
Study dates
Jan 2016to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital da Criança Santo Antônio da Santa Casa de Misericórdia

    Porto Alegre, Rio Grande do Sul, 90240-510

Other trials in Brazil

About this study

Official title: The Use of the Social Networking to Promote Educational and Consultative Actions Among Kidney Transplanted Adolescents. Comparison of the Knowledge, Satisfaction and Self-esteem Between Two Groups: a Randomized Clinical Trial.

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.

Read the detailed description

Based on literature, there are strong evidences that the use of social media improves the outcomes of chronic treatments. Currently, there is no study using social media as an education tool in kidney transplant patients in Brazil. This study is designed to answer the question: "Does the use of a popular social media such as facebook improves the knowledge, satisfaction and self-steem levels among kidney transplant adolescents when compared with their peers ?" This is a non-blinded randomized clinical trial. Patients will be randomly included into one of the two groups: the control group who will not receive any intervention or the facebook group (who will receive additional educational and consultative support through a closed facebook group) After three months, knowledge level, satisfaction level and self-esteem will be assessed by specific designed questionnaires and by the application of the Rosenberg's self-esteem scale. The study will have a sample of 122 subjects, equally divided (61 participants in each group). Collected data will be compared using the chi square test.

Being tested
Facebook group
Keywords
Kidney transplantation, Facebook, Education, Adolescent, Social Networking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Facebook groupBehavioural

    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.

Study groups in NCT03214965
Study groupRoleWhat they receive
Facebook groupActive comparatorPatients of the kidney transplantation group randomly assigned to be part of a closed facebook group.
Receives: Behavioral: Facebook group
Control groupNo interventionPatients of the kidney transplantation group that do not receive specific educational interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge about the disease

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

    Measured: 3 months

  2. Satisfaction about the treatment

    Satisfaction with the interdisciplinary team obtained by a specific designed questionnaire

    Measured: 3 months

  3. Self-esteem

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study startJan 2016
  3. Primary completionMar 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03214965
Sponsor's protocol ID
5259/16
Status last verified
Jul 2017
First submitted
19 Sep 2016
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared among other researchers.

Publications

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

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

  • 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.

  • 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.

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

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

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

  • 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

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Facebook group in people with Kidney Transplantation and Education, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge about the disease (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03214965, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in