NCT02066935

Brief Summary

The purpose of the study are: 1. To estimate the prevalence of non-adherence to immunosuppressants, and to other treatment-related aspects (smoking cessation, alcohol consumption, physical activity, and appointment keeping), in KT recipients among different KT centres across different regions of Brazil; 2. To explore multilevel factors associated to immunosuppressive adherence at the level of patient (socio-demographic, clinical), healthcare provider (patient satisfaction with the interpersonal dimension of care, trust in the transplant team, social support), healthcare organization (composition of the team, operational access, CIM transplant program practice patterns), and healthcare system and policies (perceived financial burden of the treatment regimen, insurance status, barriers to access to the immunosuppressive drugs, Brazilian region);

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,105

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

October 10, 2013

Last Update Submit

February 13, 2019

Conditions

Medication Adherence

Keywords

immunosuppressionmedication nonadherencekidney transplantation

Outcome Measures

Primary Outcomes (1)

  • adherence to immunosuppressives

    Adherence will be defined by three methods: The BAASIS instrument, blood assay of the immunosuppressives and collateral report. A patients is classified as non-adherent if he/she is considered non-adherent by any of the methods.

    1 day

Secondary Outcomes (1)

  • Risk factors to non-adherence

    1 day

Study Arms (1)

kidney transplant patient

Kidney transplanted patients for at least one year

Other: kidney transplant patient

Interventions

kidney transplant patientOTHER

kidney transplanted patients for at least one year

kidney transplant patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney Transplant patient

You may qualify if:

  • Being at least 18 years old
  • More than 1 year posttransplant
  • Willing to participate in the study by signing a written informed consent form.

You may not qualify if:

  • \- Retransplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundação Instituto Mineiro de Estudos e Pesquisas em Nefrologia

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Related Publications (12)

  • Neipp M, Jackobs S, Klempnauer J. Renal transplantation today. Langenbecks Arch Surg. 2009 Jan;394(1):1-16. doi: 10.1007/s00423-008-0335-1. Epub 2008 May 14.

    PMID: 18478256BACKGROUND

  • Sabaté E. Adherence to long-term therapies: Evidence for action. Geneva: World Health Organization. 2003.

    BACKGROUND

  • Denhaerynck K, Dobbels F, Cleemput I, Desmyttere A, Schafer-Keller P, Schaub S, De Geest S. Prevalence, consequences, and determinants of nonadherence in adult renal transplant patients: a literature review. Transpl Int. 2005 Oct;18(10):1121-33. doi: 10.1111/j.1432-2277.2005.00176.x.

    PMID: 16162098BACKGROUND

  • Michelon TF, Piovesan F, Pozza R, Castilho C, Bittar AE, Keitel E, Santos A, Goldani JC, Garcia CD, Neumann J, Garcia VD. Noncompliance as a cause of renal graft loss. Transplant Proc. 2002 Nov;34(7):2768-70. doi: 10.1016/s0041-1345(02)03403-6. No abstract available.

    PMID: 12431602BACKGROUND

  • Marsicano Ede O, Fernandes Nda S, Colugnati F, Grincenkov FR, Fernandes NM, De Geest S, Sanders-Pinheiro H. Transcultural adaptation and initial validation of Brazilian-Portuguese version of the Basel assessment of adherence to immunosuppressive medications scale (BAASIS) in kidney transplants. BMC Nephrol. 2013 May 21;14:108. doi: 10.1186/1471-2369-14-108.

    PMID: 23692889BACKGROUND

  • Registro Brasileiro de Transplante 2012 [Online]. Available at: http://www.abto.com.br/profissionais.

    BACKGROUND

  • Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

    PMID: 16079372BACKGROUND

  • Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S. Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients. Am J Transplant. 2008 Mar;8(3):616-26. doi: 10.1111/j.1600-6143.2007.02127.x.

    PMID: 18294158BACKGROUND

  • Denhaerynck K, Burkhalter F, Schafer-Keller P, Steiger J, Bock A, De Geest S. Clinical consequences of non adherence to immunosuppressive medication in kidney transplant patients. Transpl Int. 2009 Apr;22(4):441-6. doi: 10.1111/j.1432-2277.2008.00820.x. Epub 2008 Dec 24.

    PMID: 19144090BACKGROUND

  • Karlburger RL, de Pinho JHS, Basile Colugnati FA, Denhaerynck K, Medina JOP, Veras de Sandes-Freitas T, De Geest S, Sanders-Pinheiro H; ADHERE BRAZIL Study Team. Associated Factors to Nonadherence to Routine Appointments after Kidney Transplantation: The ADHERE Brazil Study. Clin Transplant. 2025 Oct;39(10):e70339. doi: 10.1111/ctr.70339.

    PMID: 41055605DERIVED

  • Marsicano-Souza EO, Colugnati FAB, de Castro BBA, Van Keullen MDS, De Geest S, Sanders-Pinheiro H. Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study. Sao Paulo Med J. 2022 May-Jun;140(3):439-446. doi: 10.1590/1516-3180.2021.0492.R1.15092021.

    PMID: 35507993DERIVED

  • Sanders-Pinheiro H, Colugnati FAB, Marsicano EO, De Geest S, Medina JOP; Adhere Brazil Consortium Group. Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol. BMC Nephrol. 2018 Feb 20;19(1):41. doi: 10.1186/s12882-018-0840-6.

    PMID: 29463231DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • HELADY S PINHEIRO, MD, PhD

    Fundação Instituto Mineiro de Estudos e Pesquisas em Nefrologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

October 10, 2013

First Posted

February 20, 2014

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 30, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

BR(1)