MedTrace Logo

Improving ImmunoSuppression Adherence After Liver or Kidney Transplantation

NCT04207125 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-11-20

No results posted yet for this study

Summary

Indication: liver (LT) or kidney Transplantation (KT)

Objectives: to measure medication adherence in liver or kidney transplant patients with and without multilevel intervention programme over time

Trial Design: prospective, single-centre, randomized controlled study

Population: patients (male/female/diverse) between 18 and 90 years of age scheduled for LT or KT

Sample Size:

75 control patients (standard of care) 75 patients in treatment group (participation in multilevel intervention programme)

Statistical Analysis: The data will be analysed descriptively; continuous variables will be summarized using mean ± SD (standard deviation) or median, minimum and maximum and categorical data will be summarized using absolute and relative frequencies. For the primary outcome (Adherence to the immunosuppressive regime measured by BAASIS) and further categorical variables, differences between the groups will be assessed by the Pearson Chi-square test or Fisher's exact test. Group differences for continuous parameters will be assessed by the two-sample T-test or Mann-Whitney-U-test as appropriate.

Trial Duration and Dates: November 2019-October 2021

Conditions

  • Adherence Intervention Post Transplantation

Interventions

BEHAVIORAL

Multilevel psychotherapeutic intervention programme

Part 1: Educational Training and Mentoring After transferring the patient from the intensive care unit to the transplant surgery unit, nurses are planning a nursing diagnosis called "therapy recommendations and coping strategies, effective implementation". 3 days after the transfer, nurses start to give information twice a day (morning and evening) about the medication, which the patients are currently taking. The nurse is also handing out a folder, which contains information about the multilevel intervention programme. Individual Treatment Approach Patients, who seem to be non-adherent during their outpatient follow-ups, are contacted through the co-investigators for a one-to-one session. The content of this session is to promote patients engagement in self-management of their chronic illness. The goal of the treatment is to improve the individual's ability to manage symptoms, treatments, physical and psychosocial consequences and lifestyle changes.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Peter Schemmer, Prof. · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2021-09-07
Completion
2021-09-07

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207125 on ClinicalTrials.gov