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

NCT ID: NCT06836544

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

ALL YOU NEED IS LOVE syllabus in 6 weeks program

Group Type EXPERIMENTAL

ALL YOU NEED IS LOVE syllabus

Intervention Type 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

Interventions

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ALL YOU NEED IS LOVE syllabus

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Society of Nephrology

OTHER

Sponsor Role collaborator

Fundacion Clinica Valle del Lili

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 24919934 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40234817 (View on PubMed)

Other Identifiers

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118-2016

Identifier Type: -

Identifier Source: org_study_id

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