Effect of the Teleconsultation of Renal Nutrition on Renal Function and Glycemic Control in Patients With DKD
Condition: Diet Modification; Diabetic Kidney Disease; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
Study type: Interventional

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.
    

Intervention name(s): Renal nutrition teleconsultation; Face-to-face consultation of renal nutrition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.; Face-to-face consultation of renal nutrition for patients with diabetic kidney disease without dialysis, monthly for 4 months.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eHealth; Nutrition Therapy; Telehealth; Diabetic Kidney Disease; Chronic Kidney Disease