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Effects of Individualized Education on Abdominal Dialysis patients

Impact of an Individualized Education tailored for the learning style on Peritoneal Dialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7nbvjkh
Enrollment
Unknown
Registered
2023-04-17
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal insufficiency, chronic

Interventions

The patient will undergo two different interventions at separate times and will be their own control (crossover study). For each patients will be assigned a unique number and in the sequence a sub-gro
to the Auditors, in addition to the conversation in the office, an audio with the key points of the orientation will also be offered
for Readers, the orientation is complemented with written material both for the time of training and for further consultation
and for Kinesthetics, orientation involves a practical activity during orientation.

Sponsors

Pontificia Universidade Católica do Paraná
Lead Sponsor
Baxter Healthcare
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age higher than 18 years old; chronic peritoneal dialysis for at least 3 months; peritoneal dialysis should be automated peritoneal dialysis; sign the informed consent

Exclusion criteria

Exclusion criteria: Not willing to participate in the study or don't sign the informed consent; Illiterate; blindness; be on assited peritoneal dialysis

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be assessed by the percentage difference in effective time on dialysis after the intervention. It will be measured as follows: time on dialysis (measured in hours) over the period divided by the time on dialysis prescribed for that period. We expect to find a relative increase in the adherence of at least 12.5% for the patients after the individualized education.

Secondary

MeasureTime frame
Percentage of patients with greater than 90% adherence. Adherence will be measured in hours of dialysis performed divided by the prescribed dialysis time. We expect to find an increase in the number of patients with adherence above 90% after the individualized education. ;Peritonitis rates. The rate is calculated by dividing the number of infection episodes adjusted for time at risk measured in months. We are not expecting any impact of the intervention in this outcome.;Comparison of phosphate serum levels, measured in mg per dl, before and after intervention. We expect to see a reduction if phosphate serum levels of at least 0.5mg per dl in average after the intervention;Time to event. The event is a composite endpoint that comprises first hospitalization, first non-fatal cardiovascular event, transference to hemodialysis, or death by any cause. We don't expect to see any significant difference in this outcome.;Difference in systolic blood pressure (mmHg) before and after intervention. We expect to see a reduction in systolic blood pressure with the intervention. ;Health-related quality of life before and after intervention using the Short Form 36. We don't expect to see any difference in quality of life before and after intervention.

Countries

Brazil

Contacts

Public ContactThyago de Moraes

Pontificia Universidade Católica do Paraná

thyago.moraes@pucpr.br+55 41 3271-1555

Outcome results

None listed

Source: REBEC (via WHO ICTRP)