Pathways to Equitable Access to Kidney Transplantation in Spain: A Transformative Mixed-methods Study Protocol

NCT07208994 | Not Yet Recruiting

• 1 other identifier: Hospital del Mar
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Chronic kidney disease (CKD) affects 10%-15% of the global population and is projected to become the fifth leading cause of years of life lost by 2040. Despite the benefits of kidney transplantation (KT), access remains inequitable. In Spain, which leads the world in KT rates per million population, disparities may persist due to structural, territorial, and professional barriers. This study aims to explore the mechanisms underlying treatment deprivation and inequity in KT access using a mixed-methods approach. Methods and analysis. A transformative mixed-methods design will be implemented in four phases: (1) systematic reviews on instruments assessing treatment deprivation and inequalities in CKD and KT; (2) a multicenter quantitative study and qualitative interviews with professionals and patients; (3) a pre-experimental evaluation of a training program on KT; and (4) triangulation and translation of findings to inform national policy. The protocol adheres to GRAMMS and PRISMA guidelines. Ethics and dissemination. Approved by the Hospital del Mar Research Institute Ethics Committee (ID: XX), the study complies with EU data protection laws. Informed consent will be obtained. Findings will be disseminated via peer-reviewed publications, conferences, social media, and patient forums to support equity-focused strategies in KT.

Conditions

Chronic Kidney Disease; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Inequities in access to kidney transplantation among individuals with chronic kidney disease

  Quantitative assessment of inequities in access to kidney transplantation using validated questionnaires developed in Phase 1, complemented by sociodemographic and clinical variables. The outcome will measure disparities according to age, sex, socioeconomic status, region, and clinical condition.

  Baseline (at study inclusion)

Secondary Outcomes (2)

• Patient experiences related to access to kidney transplantation

  Baseline (at study inclusion)

• Professional perspectives on inequities in access to kidney transplantation

  Within the first 12 months of the study

Other Outcomes (1)

• Thematic categories of inequities in kidney transplantation access

  At study completion (24 months)

Interventions

Description OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A transformative mixed-methods design will be implemented in four phases: (1) systematic reviews on instruments assessing treatment deprivation and inequalities in CKD and KT; (2) a multicenter quantitative study and qualitative interviews with professionals and patients; (3) a pre-experimental evaluation of a training program on KT; and (4) triangulation and translation of findings to inform national policy.

You may qualify if:

• People with CKD

You may not qualify if:

• Pediatrics

Sponsors & Collaborators

• Hospital del Mar: lead
• Organización Nacional de Trasplantes (ONT): collaborator

Study Sites (1)

Escola Superior d'Infermeria Hospital del Mar

Barcelona, 08020, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Montserrat Sanclemente Dalmau, Dr

  Escola Superior d'Infermeria Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Laura Rota Musoll, Dr

  Universitat de Vic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GUILLERMO PEDREIRA ROBLES, Dr

CONTACT

+34 618491674; gpedreira@psmar.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: October 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data (IPD) will become available after completion of the study and publication of the main results. Data will remain accessible for a period of 5 years following publication.
• Access Criteria: De-identified individual participant data will be made available to qualified researchers upon reasonable request. Access will require submission of a research proposal that aligns with the study objectives, approval by the principal investigator, and a signed data access agreement to ensure compliance with ethical and legal standards.

Locations

ES (1)