Clinical trial NCT05715580: Impact of Nursing Intervention in Kidney Transplant Recipients Adherence
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplant; Complications
Keywords: Kidney transplantation
Treatment adherence and compliance
Clinical trial
Health Education
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Have a kidney transplant
* Agree to participate

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Adherence to prescribed medication
timeFrame: Basal, 6 and 12 months after the basal
Secondary outcomes:
measure: Changes in Adherence to physical exercise
timeFrame: Basal, 6 and 12 months after the basal
measure: Changes in Adherence to healthy food
timeFrame: Basal, 6 and 12 months after the basal
measure: Changes in alcohol consumption
timeFrame: Basal, 6 and 12 months after the basal
measure: Changes in tobacco consumption
timeFrame: Basal, 6 and 12 months after the basal
measure: Changes in Presence of emotional well-being
timeFrame: Basal, 6 and 12 months after the basal
measure: Changes in Security / Prevention of unintentional injuries
timeFrame: Basal, 6 and 12 months after the basal
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Comunidad De Madrid
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Araceli Faraldo Cabana, Nurse
role: PRINCIPAL_INVESTIGATOR
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