Renal TransplantTransitionNCT06836544
Efficacy of the ALL YOU NEED is LOVE Healthcare Transition Syllabus Among Pre- and Posttransplant Adolescents in Cali, Colombia
A study testing ALL YOU NEED IS LOVE syllabus in people with Renal Transplant, run by Fundacion Clinica Valle del Lili.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Renal Transplant
- What is being tested?
- ALL YOU NEED IS LOVE syllabus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
- Being tested
- ALL YOU NEED IS LOVE syllabus
- Keywords
- Pediatric nephrology, Educational, Healthcare transition, Kidney failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALL YOU NEED IS LOVE syllabusBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| "ALL YOU NEED IS LOVE" syllabus (Spanish version) | Experimental | ALL YOU NEED IS LOVE syllabus in 6 weeks program Receives: Behavioral: ALL YOU NEED IS LOVE syllabus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Apr 2016
- Primary completion31 May 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Collaborators
- International Society of Nephrology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836544
- Sponsor's protocol ID
- 118-2016
- Acronym
- Transition
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24919934Forero-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.
PubMed 40234817
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the ALL YOU NEED is LOVE Healthcare Transition Syllabus Among Pre- and Posttransplant Adolescents in Cali, Colombia
- ClinicalTrials.gov ID
- NCT06836544
- Acronym / sponsor ID
- Transition / 118-2016
- Conditions
- Renal Transplant
- Keywords
- Pediatric nephrology, Educational, Healthcare transition, Kidney failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Collaborators
- International Society of Nephrology
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "ALL YOU NEED IS LOVE" syllabus (Spanish version) | Experimental | Behavioral: ALL YOU NEED IS LOVE syllabusALL YOU NEED IS LOVE syllabus in 6 weeks program |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALL YOU NEED IS LOVE syllabus1. 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 | Behavioural | "ALL YOU NEED IS LOVE" syllabus (Spanish version) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 24919934Betz 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.
- Derived from this study: PubMed 40234817Forero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ALL YOU NEED IS LOVE syllabus in people with Renal Transplant, run by Fundacion Clinica Valle del Lili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of the "ALL YOU NEED IS LOVE" syllabus (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.