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
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
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:
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:
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.
Given the high volume of subjects seen in each of the kidney transplant consultations throughout the year, it is expected to recruit the sample in the estimated period. For example, at the Hospital Clínico San Carlos and Hospital La Paz there are more than 600 patients under follow-up, while at Hospital Ramón y Cajal there are more than 800, and at Hospital 12 de Octubre more than 2,000, with an average of daily, in each one of the consultations, of minimum 20 visits.
An intermediate analysis will be carried out, when a third of the sample has undergone the assessment of the 6 months after the intervention, and based on the result obtained, the necessary sample will be recalculated.
This calculation has been estimated with the GRANMO v.7.12 program. Randomization To carry out the randomization, firstly, it will be stratified by hospital center. Once the stratification has been carried out, the random assignment will proceed by means of a simple randomization with a sequence of random numbers generated by means of the Excel® computer program, which uses the Mersenne Twister algorithm. To do this, a sequenced list will be generated that will contain even and other odd numbers in equal amounts, assigning the patients whose random number is even to the control group and to the intervention group if the number is odd. In this way, any person who attends the consultation, meets all the inclusion requirements and none of the exclusion requirements, will have the same probability of being assigned to one or the other group. The nurse from the Renal Transplant Clinic will be in charge and responsible for carrying out the assignment process, using the random sequence provided by the principal investigator in a sealed envelope, in such a way that the nurse in charge of the assignment will not know it until the same moment of carrying out the intervention or not.
Data collection The Renal Transplant Clinic nurses will select the subjects by consecutive sampling, from a given date, until completing the sample assigned to each of the five Nursing Clinics. This allocation will be carried out based on the number of patients under follow-up in each consultation.
Once the subjects have been selected by consecutive sampling from a given date, the nurse from the Renal Transplant Clinic, in charge of conducting the interview, will explain the objectives of the study to the study subject and obtain their written informed consent.
Subsequently, membership in the control group or intervention group will be randomized.
For biomedical data, an exhaustive review of the patient's Clinical History will be carried out. These data will be collected by an independent investigator, blind to the intervention group to which the patient belongs (control group or intervention group), both in the baseline assessment and in the measurements at 6 and 12 months.
Inclusion Criteria:
Exclusion Criteria:
a_faraldo@hotmail.com+34913303000 ext. 3156
iortuno@ucm.es+34913303000 ext. 3156
Madrid, Madrid 28007, Spain
fgonzalezgarcia@salud.madrid.org915868000
virgy_hg@hotmail.com913368000
a_faraldo@hotmail.com913303000 ext. 3156
enriquetaisabel.nuno@salud.madrid.org913908000
mjose.santana@salud.madrid.org917277000