Efficacy of the ALL YOU NEED is LOVE Healthcare Transition Syllabus Among Pre- and Posttransplant Adolescents in Cali, Colombia

NCT06836544 | Completed DMC

• 1 other identifier: 118-2016
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: To achieve optimal outcomes, adolescents with chronic or end-stage kidney disease must undergo healthcare transition (HCT) preparation from a pediatric- to an adult-focused setting. The pediatric nephrology group at the Fundación Valle del Líli in Cali, Colombia, collaborated with the University of North Carolina Chapel Hill STARx Program and Hospital Infantil de México Federico Gómez to start an HCT preparation program using their tools. The objective of this study was to evaluate the efficacy of the "ALL YOU NEED IS LOVE" syllabus (Spanish version) and its effects on HCT readiness in young patients with kidney failure, including renal transplants. Methods: A pre-test/post-test quasi-experimental study was conducted without control group in 11- to 21-year-old consecutive patients with kidney failure followed at the Fundación Valle de Lili. Using the TRxANSITION Index, HCT readiness skills were measured before and after implementing the "ALL YOU NEED IS LOVE" syllabus, an educational curriculum delivered in three monthly 2-hour sessions. Analysis was performed using linear mixed models in R Studio software to evaluate intervention effects while accounting for participant characteristics.

Conditions

Renal Transplant

Keywords

Pediatric nephrology; Educational; Healthcare transition; Kidney failure

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of the "ALL YOU NEED IS LOVE" syllabus

  The STARx questionnaire (SELF-MANAGEMENT AND TRANSITION TO ADULTHOOD WITH RX=TREATMENT) contains three subdomains that focus on three different areas of transition related knowledge - communication with medical provider, disease knowledge, and self-management. Each item is scored individually and worth a maximum of 5 points. Each item is answered by the patient on a 1 - 5 Likert scale and receive a corresponding score of 1 - 5 points for each item. Subdomain scores are combined to create a total score, ranging from 0 - 90.

  1 year

Study Arms (1)

"ALL YOU NEED IS LOVE" syllabus (Spanish version)

EXPERIMENTAL

ALL YOU NEED IS LOVE syllabus in 6 weeks program

Behavioral: ALL YOU NEED IS LOVE syllabus

Interventions

ALL YOU NEED IS LOVE syllabus BEHAVIORAL

1. Week 1: Introduction to the Kidneys 2. Week 2: Chronic Kidney Disease, Medication Management 3. Week 3: Making Healthy Choices 4. Week 4: Learning about Self-Care 5. Week 5: Becoming Independent 6. Week 6: Review and Self-assessment

"ALL YOU NEED IS LOVE" syllabus (Spanish version)

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 11 to 21 years along with their primary caregivers
• Either renal transplant recipients or in a renal transplant protocol
• Under follow-up by the Nephrology Service at Fundación Valle del Lili.

You may not qualify if:

• Patients were excluded if they did not sign the informed consent and/or assent to participate in the study.
• If they lost their care agreement with Fundación Valle del Lili due to administrative reasons related to their health insurance provider

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• International Society of Nephrology: collaborator

Related Publications (2)

• Betz CL, Ferris ME, Woodward JF, Okumura MJ, Jan S, Wood DL. The health care transition research consortium health care transition model: a framework for research and practice. J Pediatr Rehabil Med. 2014;7(1):3-15. doi: 10.3233/PRM-140277.

  PMID: 24919934 BACKGROUND

• Forero-Delgadillo JM, Ochoa Jimenez VA, Padilla-Guzman A, Santamaria-Suarez MDP, Gonzalez-Fernandez MC, Medeiros M, Parraga P, de Ferris MED, Barbosa MM, Portilla-Buenaventura AM, Restrepo JM. Efficacy of the ALL YOU NEED IS LOVE healthcare transition syllabus among pre- and posttransplant adolescents in Cali, Colombia. BMC Nephrol. 2025 Apr 15;26(1):192. doi: 10.1186/s12882-025-04092-5.

  PMID: 40234817 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: April 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share