Chronic Kidney Disease Clinical Trial
— EPAKOfficial title:
Effect of an Educational Program on Dietary Adherence, Nutritional Knowledge, Nutritional Status, Metabolic Control and Quality of Life in Predialysis, Peritoneal Dialysis and Hemodialysis Patients With Chronic Kidney Disease
A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis. A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups.
Status | Recruiting |
Enrollment | 63 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women over 18 years old - Residence in Mexico City, (in order to make it easier for them to attend the educational workshops that will be held within the hospital facilities). - Patients who are active in the nephrology office of National Institute of Medical Science and Nutrition - With more than 3 months of diagnosis of chronic kidney disease in pre-dialysis phase (glomerular filtration rate < 60 ml/min/1.73m2) at National Institute of Medical Science and Nutrition - With more than 3 months with peritoneal dialysis treatment in the National Institute of Medical Science and Nutrition - With more than 3 months with hemodialysis treatment in the National Institute of Medical Science and Nutrition - Signed informed consent form Exclusion Criteria: - Patients with uncorrected cognitive problems: - Patients with post-dialytic syndrome (uremia). - Patients with neurological alterations induced by renal failure. - Patients with mental or psychiatric illness that prevents them from learning and following directions: - Patients with persistent delirium - Patients with schizophrenia - Patients with manic episode - Patients with confusional syndrome - Patients with minor or major neurocognitive deficits - Patients with dissociative amnesia - Patients with neurodevelopmental disorder - Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM IV- TR) diagnostic criteria for substance abuse and dependence. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients´ dietary attitude | Measurement of patients' attitude toward fluid restriction and dietary modifications and their impact on daily life. Adherence to the diet will be measured by the renal adherence attitude questionnaire (RAAQ), at the beginning of the study and after the end of the intervention.
RAAQ questionnaire will be filled out by the patient with the purpose of evaluating the patients' attitudes and behaviors in relation to diet adherence. The questionnaire consists of 26 items with a 5-point Likert scale indicating total agreement (5 points) or total disagreement (1 point). The lowest score on the scale is 26 points and the highest is 130 points. Higher scores on this scale are associated with a more positive patient attitude to dietary restrictions and to a higher dietary adherence. |
From enrollment to the end of the intervention at 5 months | |
Primary | Dietary adherence | Extent to which a patient's eating behavior corresponds to the recommendations agreed upon with the nutritionist. Adherence to the diet will be measured by a three-day food record at the beginning of the study and after the end of the intervention.
The evaluation of the diet will be carried out by a trained nutritionist, describing the amount and type of food consumed by the patients in a three-day period. The three-day average consumption of calories (kcal), protein (g), sodium, potassium and phosphorus (mg) will be estimated. Good adherence will be considered when the actual intake of these nutrients is between 90 and 110% of the recommended intake for each patient. |
From enrollment to the end of the intervention at 5 months | |
Primary | Nutritional knowledge | Assessment of the level of knowledge about food groups and nutrients that are important in chronic kidney disease. Knowledge will be assessed by the CONURE self-administered questionnaire consisting of 35 multiple-choice questions related to sodium, potassium, phosphorus, protein and the use of beverages and nutritional supplements, at the beginning and end of the intervention. The level of knowledge will be classified into three categories according to the number of correct answers obtained: low knowledge with less than 60% correct answers, regular knowledge with 60-80% correct answers and good knowledge with more than 80% correct answers. | From enrollment to the end of the intervention at 5 months | |
Secondary | Muscle status | Measures that quantify a person's muscularity and is a reflection of nutritional status.
The assessment of muscle status will be performed by calculating the arm muscle area (AMA) which will be compared to the adult reference value (%AMA). Patients will be classified as normal muscle status if the %AMA is greater than 90%, as mild, moderate and severe muscle depletion if the %AMA is between 90 and 76%, 75 and 65% and less than 65%, respectively. |
From enrollment to the end of the intervention at 5 months | |
Secondary | Muscle functionality | Capacity of muscle mass to perform its functions, mainly related to strength and ability to perform daily activities.
The measurement of muscle functionality will be performed with dynamometry and is related to the nutritional status of the patients. Low strength will be considered when the measurement is < 20 kg in women and < 30 kg in men. |
From enrollment to the end of the intervention at 5 months | |
Secondary | Nutritional status of predialysis patients | A person's body situation as a result of the energy balance between caloric intake and metabolic needs. It is an internal condition of the individual that refers to the availability and utilization of energy and nutrients. Nutritional status will be assessed by applying the Subjective Global Score (GSV), which is a diagnostic tool for malnutrition in pre-dialysis patients, before and after the intervention.
SGA is a tool consisting of 8 questions to which a score between 1 and 7 is assigned according to the alteration of each component. Based on the score obtained, the patient's nutritional status is classified in one of three categories: 1) good nutritional status (6 and 7 points in most of the components), 2) mild/moderate malnutrition (3 to 5 points in most of the components) and 3) severe malnutrition (1 and 2 points in most of the components). |
From enrollment to the end of the intervention at 5 months | |
Secondary | Nutritional status of dialysis patients | A person's body situation as a result of the energy balance between caloric intake and metabolic needs. It is an internal condition of the individual that refers to the availability and utilization of energy and nutrients. Nutritional status will be assessed by applying the Malnutrition Inflammation Score (MIS), which is a diagnostic tool for malnutrition in dialysis patients, before and after the intervention.
MIS is a tool comprising 10 components divided into 4 sections. Each of the evaluated parameters is assigned from 0 to 4 points according to the degree of deficiency. The minimum and maximum score of the tool is 0 and 30 points, respectively. The nutritional status is determined according to the sum of the points, with four possible diagnoses: normal nutritional status (< 3 points), mild malnutrition (3 to 5 points), moderate malnutrition (6 to 8 points), severe malnutrition (> 9 points), and severe malnutrition (> 9 points). |
From enrollment to the end of the intervention at 5 months | |
Secondary | Patients´ quality of life | Conditions that an individual must enjoy in order to be able to satisfy his needs. This, so that he/she not only survives, but also lives comfortably. The assessment of quality of life will be made at the beginning and end of the intervention, through the self-applicable questionnaire Kidney Disease Quality of Life Short Form (KDQOL-SF36), which consists of a generic section of 12 items related to health status, daily activities and emotional problems, and another specific section of 24 items related to kidney disease, symptomatology and effects of kidney disease on daily life. The response to each of the questions is classified between 1 and up to 6 points according to the degree of affectation. The higher the final score of the questionnaire, the higher the quality of life. Patients will be classified as having good quality of life if they score > 50 points and poor quality of life with < 50 points. | From enrollment to the end of the intervention at 5 months |
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