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

February 14, 2025 updated by: Fundacion Clinica Valle del Lili

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "ALL YOU NEED IS LOVE" syllabus (Spanish version)
ALL YOU NEED IS LOVE syllabus in 6 weeks program
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Collaborators

International Society of Nephrology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 118-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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