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

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.

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Key information

Conditions

Renal Transplant Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

11 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

ALL YOU NEED IS LOVE syllabus

Behavioral

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

Primary outcomes

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

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Collaborators

International Society of Nephrology

Registry information

Acronym: Transition

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Feb 20, 2025
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed