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临床试验/NCT05715580
NCT05715580尚未招募不适用

A Clinical Trial to Assess the Impact of Nursing Intervention in the Adherence to Drug Treatment and to a Healthy Lifestyle in Kidney Transplant Patients

Hospital San Carlos, Madrid10 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
204
试验地点
10
主要终点
Changes in Adherence to prescribed medication

研究概览

简要总结

The goal of this clinical trial is to analyse the impact of an informative nursing intervention in the adherence to drug treatment and a healthy lifestyle in kidney transplant patients and the effect of poor adherence on clinical predictors of poor kidney function.

The main question[s] it aims to answer are:

  • Is it possible improve the drug adherence of kidney recipients with a nursing information intervention?
  • Is it possible improve the healthy lifestyle adherence of kidney recipients with a nursing information intervention? Participants will be divided into two groups: Intervention group: in which a health education action will be carried out and Control group in which the usual clinical practice will be maintained.

详细描述

A controlled, multicenter, single-blind clinical trial will be carried out. For this, 3 measurements will be made, a first baseline, prior to the intervention, and another two follow-up six and twelve months after the first. Patients will be divided into two groups:

  1. Intervention group: in which a health education action will be carried out through the delivery of an Information Guide for adults with a kidney transplant and the regulated explanation of each of the items it contains. It will be carried out by the nurse from the Kidney Transplant Clinic responsible for follow-up, who in turn will receive an online training session, prior to the start of recruitment, on what information to provide and how to provide it.
  2. Control group in which the usual clinical practice will be maintained, which consists of providing the information in the immediate post-transplant period and resolving any doubts that the patient may have during the follow-up period.

The study will be carried out in the five existing Nursing Consultations, specific to Renal Transplantation, belonging to as many hospitals of the Public Health Network of the Community of Madrid.

Study population Those patients with a functioning kidney transplant, under follow-up by one of the nursing consultations where the research will be carried out, over 18 years of age who agree to participate and sign the informed consent will be selected. Patients monitored by the clinic whose habitual residence is in an Autonomous Community other than Madrid will be excluded, those in which the frequency of revision in the Renal Transplant Clinic is scheduled for more than 6 months, as well as those hyperimmunized pre-transplant patients (Presence of preformed antibodies >75%) and those who are not trained to give their informed consent and those who do not read or understand Spanish well.

Calculation of sample size and sampling. In order to achieve the main objective of evaluating the efficacy of an informative intervention by the nurse in the adherence of the kidney transplant recipient and according to the calculations made, starting from an adherence based on the bibliography, of 50% in both arms of the study, and to detect a change of at least 20% in it, a sample of 93 patients per arm will be needed, plus an estimated 10% of losses, which results in 102 patients per arm, 204 in total.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a kidney transplant
  • Agree to participate

排除标准

  • If the habitual residence is not in Madrid
  • Those whose review frequency in the Kidney Transplant Consultation is planned for more than 6 months
  • Pre-transplant hyperimmunized patients (Presence of preformed antibodies >75%)
  • Those who are not qualified to give their informed consent
  • Those who do not read or understand the document well Spanish

结局指标

主要结局

Changes in Adherence to prescribed medication

时间窗: Basal, 6 and 12 months after the basal

Measured by the Morisky-Green test

次要结局

  • Changes in alcohol consumption(Basal, 6 and 12 months after the basal)
  • Changes in tobacco consumption(Basal, 6 and 12 months after the basal)
  • Changes in Adherence to healthy food(Basal, 6 and 12 months after the basal)
  • Changes in Security / Prevention of unintentional injuries(Basal, 6 and 12 months after the basal)
  • Changes in Adherence to physical exercise(Basal, 6 and 12 months after the basal)
  • Changes in Presence of emotional well-being(Basal, 6 and 12 months after the basal)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Araceli Faraldo Cabana

Investigador Principal

Hospital San Carlos, Madrid

研究点 (10)

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