Clinical trial NCT03344549: Effect of the Teleconsultation of Renal Nutrition on Renal Function and Glycemic Control in Patients With DKD
Official title: Effect of Nutritional Intervention Through Teleconsultation on Glomerular Filtration Rate and Glycated Hemoglobin A1c in Patients With Diabetic Kidney Disease in Stage G3a, G3b and G4.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Diabetic Kidney Disease
Chronic Kidney Diseases
Keywords: eHealth
Nutrition Therapy
Telehealth
Diabetic Kidney Disease
Chronic Kidney Disease
Lead sponsor: Hospital Civil Juan I. Menchaca
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the experimental group, the nutritional intervention will be done through teleconsultation with the free technological tool chosen (the patients from home and the nutritionist from the remote clinic); and in the control group will be offered the nutritional intervention through face-to-face consultations carried out by the nutritionist of the nutrition service of the institution, both arms will be intervened monthly for four months, the duration of the sessions will be 45 minutes and will include evaluation or re-evaluation of dietary data, diagnosis, treatment and educational approach.
Primary purpose: TREATMENT

Brief summary: The modern era is characterized by progress, development and social and economic globalization. Currently the electronic technology has applications in a wide variety of work areas. A clear example of this, is telemedicine. The technological tools are increasingly used every day in the improvement of the processes and the attention in health, in the last decades, telemedicine has grown exponentially becoming more accessible to the population.

On the other hand, and in the same way, the number of people with chronic degenerative diseases such as diabetes and chronic kidney disease are increasing with alarming numbers, The health system can not offer the attention to the great demand. The strategies used until now for its management have gradually evolved towards a more effective prevention and treatment approach which requires a multidisciplinary team. Investigate the use of new tools that promise to improve the service, has also become a prevailing need. Therefore, the purpose of this study is to know the effect of nutritional teleconsultation on renal function and glycemic control of patients with Diabetic Kidney Disease (DKD) in pre-dialysis stages (specifically G3a, G3b and G4).

Detailed description: Chronic kidney disease (CKD) is the result of various chronic-degenerative diseases, including diabetes mellitus. In Mexico, it is considered a catastrophic disease due to the increasing number of cases, high investment costs and human resources, limited infrastructure, late detection of the disease, and high rates of morbidity and mortality in substitution programs.

So far, there is no record of patients with CKD in Mexico, so the precise number of patients in any of their stages is unknown. International databases, estimate an incidence of 421 patients with terminal CKD treated per million of population per year in our country (represented by the state of Jalisco), and a prevalence of 1,568 cases per million of population; figures that are considered the highest in the world.

Currently our country lives an extraordinarily complex scenario, has shown the highest rate of incidence of terminal kidney disease in recent years, which may be related, at least in part, to the increase in the prevalence of risk factors and the incongruence between needs of patients and the health care system, largely designed for the management of acute diseases. The CKD is among the first 10 causes of general mortality in Mexico, with a survival calculated in average months, from the entrance to a substitution therapy, of 30.6 months. The medical expense provided by the Mexican Institute of Social Security (an public agency that provides coverage to 66% of Mexicans with social security), for the treatment of terminal CKD in 2007, was estimated at $ 4 billion pesos, equivalent 60% of the total medical expense; and it is estimated that, due to the high incidence rates, in 2043 the investment costs will reach 20 billion pesos, figures that can not be paid.

The dimensions of chronic kidney disease show it as a public health problem that requires the creation of new intervention and education programs focused on the prevention of kidney disease and its causes. Currently, doctors have serious difficulties in providing optimal management. It is common for patients during the early stages of CKD not to comply with recommendations for effective control. They usually present negative life habits, difficult to change only with medical intervention. Many of the risk factors for both the onset and progression of CKD are related to unhealthy eating habits. It is widely known that, optimizing the quality of diet and lifestyles, in individuals with CKD at early stages have substantial benefits in terms of preventing the incidence and progression of the disease, as well as in the mortality of this population. Interventions based on multidisciplinary models, developed in populations at risk and in early stages of kidney disease have proven useful for delaying progression and postponing patients' admission to substitution therapy.

As the CKD progresses, the risk of presenting complications such as malnutrition, hyperphosphatemia and hyperkalemia increases significantly, which increases the risk of morbidity and mortality, especially in more advanced stages of the disease. Nutrition interventions to control and modify these risk behaviors become key points for the management of patients with CKD.

A better CKD care also requires economic resources, needs a greater number of nephrologists, nutritionists, nurses and other health professionals specialized in this disease entity. In Mexico, there are only 750 certified specialists in nephrology, the nephrologist patient ratio is 1: 204, values below the demand for health services. A similar analysis carried out in nutrition professionals in our country indicates that, in 2012, there were 2.4 nutritionists per 1,000 inhabitants, of whom only 78% worked in nutrition-related activities. In addition, the area of renal nutrition is little explored by health professionals, due to the lack of specialty certifications, the few existing courses lose rigor and formality due to the lack of an organ that regulates them; all this results in limited access to quality health care.

Deficiencies in the function and structure of health programs for chronic diseases prevent the achievement of good results; and in addition to this, when adherence to treatment is tested, only 44% of patients manage to maintain an adequate adherence that improves prognosis and modifies the natural course of the disease. Studies reveal that patients with chronic kidney disease are often dissatisfied with the communication they have with their health care provider and perceive little or no knowledge about their diagnosis and treatment. Some of the external agents that exacerbate this scenario in Mexico are: social inequality, difficult access to health institutions, the educational level of the population and the economy of the country. In contrast to this and as part of a possible solution, globalization has allowed, as the technology develops, to provide users with access to a wide variety of applications and health portals. According to the National Survey of Availability and Use of Information Technologies in Households in México, 57.4% of the population in Mexico call themselves Internet users and 71.5% as mobile phone users, of which 70.7% declare surfing in Internet through your mobile device. Currently with the internet there is a great variety of information for the patient with CKD, which offers facilities in the understanding of the disease.

Telemedicine emerged with the aim of allowing the health professional to meet the patient when it was otherwise impossible; However, today health providers also use mobile technology to connect with their patients and thus improve their overall relationship, strengthen the patient's autonomy and their ability to face everyday health problems and be more active in their own caring, all these skills suitable for the optimal care of the population with CKD.

Telemedicine in the nephrology has been used to improve different processes, shown that it reduces the waiting times for consultation with the specialist, decreases the number of patients who are referred to the nephrologist without being necessary, decreases costs and increases the coverage area of the service provider. Although there are studies that do not find the superiority in the effectiveness of synchronous telemedicine compared with conventional intervention, others conclude that effectiveness is similar, with the great benefit in reducing costs for transfer and / or for absence from work, which exposes synchronous telemedicine as an available and safe option for clinical practice.

There are few studies of telemedicine that offer specialized nutritional intervention through teleconsultations, the most developed in patients with diabetes mellitus with inconclusive results, however, none (as far as we have knowledge) in patients with CKD. Therefore, the interest of knowing the effect of the nutrition teleconsultation on renal function and glycemic control in the patient with diabetic kidney disease in stages G3a, G3b and G4 was born.

The working hypothesis is that, there is a difference between the nutritional intervention through teleconsultation and the face-to-face consultation in patients with diabetic kidney disease in stage G3a, G3b and G4.

For the calculation of sample size, the formula was used to compare means of independent samples. A size of 34 patients per group was estimated, considering an expected difference in the estimated glomerular filtration rate of 5.82 ml / min / 1.73 m2 reported in a previous study.

The nutritional intervention was considered as the independent variable, which consists of providing nutritional therapy through two modalities, face-to-face consultations in the hospital or through teleconsultations, with a monthly frequency for 4 months. The duration of each consultation is approximately 45 minutes and includes the evaluation or re-evaluation, diagnosis, treatment and educational approach. It will be measured as assistance or non-attendance to the consultation. Non-attendance to more than two consultations is considered an exclusion criterion for the subject.

Two dependent variables were considered, the glycated hemoglobin (HbA1c), which is defined as the result obtained in percentage (%) of the blood glycated hemoglobin test. And the estimated glomerular filtration rate (eGFR), which is defined as the result obtained in milliliters per minute per 1.73 square meters of body area (thousand ml / min / 1.73m2), based on the calculation of the mathematical formula proposed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) for the estimation of the glomerular filtration rate.

PROCESS

The detection of patients is carried out in the nephrology department of the Juan I. Menchaca hospital, both in the morning and afternoon sessions. The identification of patients is carried out during the consultation with the nephrologist, where the selection criteria are evaluated and the patient is invited to participate in the study and to sign the agree consent.

After the patient's acceptance to participate in the study, the initial evaluation is carried out, which includes contact, demographic, anthropometric and dietary data; and the patient is trained to fill the dietary record at home. Anthropometric data are evaluated by standardized nutritionist trained with the correct technique. The biochemical indicators are requested by the nephrologist at the time of the consultation and the results of these are obtained from the institution's own data system.

After the initial evaluation, the probabilistic group assignment is carried out with the simple method without replacement, which is carried out using a sealed envelope. After the appointment of the group, the patient is scheduled for his first nutrition consultation (both arms).

In the teleconsultation group, two days before the first nutrition consultation, the patient is advised by telephone - or the family member in charge - about the use of the free technological tool to be used during the video conference.

In the patients of the intervention group, the nutritional intervention is carried out through teleconsultation with the free technological tool chosen (the patients from home and the nutritionist from the remote clinic); and the patients of the control group are offered the nutritional intervention through face-to-face consultations carried out by the nutritionist of the nutrition service of the institution. All patients will be confirmed by phone the date and time of their next nutrition consultation, both the control group and the intervention group.

The evaluation of the glycated hemoglobin (HbA1c) and the estimated glomerular filtration rate (eGFR), will be done at the beginning and at the end of the intervention. Adherence is also evaluated at the beginning and end, by means of dietary records for the calculation of energy and protein intake.

STATISTIC ANALYSIS For the comparison of proportions between the groups, it will be done with X2 or Fisher's exact test and to compare quantitative variables, Student's T or Mann-Whitney U will be used. For the intra-group comparisons, Mc Nemar will be used for the qualitative variables and Anova for repeated samples or Friedman's Anova for the quantitative variables. For the analysis of the interaction or intervening variables, a stratified statistical analysis will be carried out, using contingency tables and the Mantel-Haenszel method. The results will be considered statistically significant if the value of p \<0.05.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetic kidney with eGFR \<60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively).
* Patients who can read and write.
* Patients who have access to the internet and have a computer, tablet or smartphone.
* Patients who signed the voluntary agreement to participate.

Exclusion Criteria:

* Patients who have received prior nutritional treatment for the control of diabetic kidney disease.
* Patients with actual consumption of food supplements and / or keto analogues.
* Patients with anemia or recent transfusions (in the last 3 months).
* Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, etc.).
* Patients with serious difficulties in communication or intellectual deficit that impedes the ability to understand the intervention.
* Patients with refractory arterial hypertension.
* Patients who do not attend ≥ 2 nutritional interventions.
* Patients who present serious complications during the intervention (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, etc.).

Primary outcomes:
measure: Glycemic Control
timeFrame: Baseline and at 4 month
measure: Renal Function
timeFrame: Baseline and at 4 month
Secondary outcomes:
measure: Number of Participants With Adherence to Treatment
timeFrame: Baseline and at 5 month
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Nuevo Juan I Menchaca
state: Jalisco
Study officials:
affiliation: Hospital Civil Juan I. Menchaca
name: Ari Cisneros, Bachelor
role: PRINCIPAL_INVESTIGATOR
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