Clinical trial NCT06351007: Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Predialysis
Peritoneal Dialysis
Hemodialysis
Educational Activities
Adherence
Nutritional Status
Keywords: Education program
Adherence
Nutritional knowledge
Nutritional status
Quality of Life
Chronic kidney disease
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Nutritional treatment is of great importance for an adequate control of chronic kidney disease. An adequate and personalized design of the nutritional plan, as well as permanent follow-up and support, allow slowing down the evolution of the disease, preserving the nutritional status, improving survival expectations, as well as the patient's quality of life. A difficulty faced by the health team dedicated to the management of chronic kidney disease (CKD) is the poor adherence of patients to treatment, specifically to nutritional therapy. Many patients with CKD express that adherence to dietary restrictions is the most difficult part of the treatment regimen because it affects food preferences and alters lifestyle. Approximately, only 31.5% of patients have adequate dietary adherence.

Educational programs increase knowledge about CKD and renal nutrition, improve concentrations of biochemical parameters, and improve quality of life; however, it is not clear that they improve adherence to the dietary plan. Although knowledge is a necessary precondition for behavioral change, it is not sufficient to improve adherence to treatment. In this regard, psychological interventions, designed to increase patients' confidence and self-management by increasing skills and strategies for behavioral change, can be useful to improve metabolic control and adherence. Given the above, it is essential to design and implement multidisciplinary educational interventions to improve patients' adherence to treatment.

The aim of the 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.

The study subjects will be active patients of the nephrology clinic of the National Institute of Medical Science and Nutrition, who meet the inclusion criteria. They will be invited to participate in the protocol and those who accept will sign the informed consent form. Thirty-two pre-dialysis patients will be recruited, of whom 21 will receive the educational intervention and 11 will be part of the control group. Similarly, 32 dialysis patients (peritoneal or hemodialysis) will be recruited, 21 of whom will receive the educational intervention and 11 will be part of the control group.The sample size was estimated through the comparison of means with the analysis of variance formula for three groups, based on the main variable of the study, which is dietary adherence. A confidence level of 95%, statistical power of 80% and losses of 30% were taken into account.

After recruitment and signature of the consent form, the three study groups were formed by block randomization: control group, group of pre-dialysis patients and group of dialysis patients.

The following variables will be extracted from the clinical record: age, sex, educational level, socioeconomic level, etiology of renal disease, time on dialysis (if applicable), use of medications and the most recent biochemical parameters, no older than 2 months.

Dietary adherence will be measured in patients in the three groups, with a 3-day food consumption record and the application of The renal adherence attitude questionnaire. The level of nutritional knowledge will be measured with the CONURE self-applicable questionnaire, which is a tool to assess knowledge of renal nutrition in dialysis and pre-dialysis patients that was developed and validated (content and appearance) by a group of nutritionists from our hospital. Nutritional status will be assessed by anthropometric measurements (elbow width, weight, height, arm circumference, tricipital skin fold), subjective global assessment or malnutrition inflammation score, protein energy wasting criteria and dynamometry. Finally, quality of life will be assessed with the Kidney Disease Quality of Life - short form 36 (KDQOL-SF36).

The control group will receive standard nutritional care consisting of dietary prescription with follow-up for resolution of doubts and adjustment of the dietary plan every 2-3 months. The intervention group, in addition to the dietary prescription, will receive the educational intervention.

The dietary prescription will be given to the patients of the three groups. Based on the nutritional status, biochemical parameters and stage of renal disease, the dietary plan will be calculated and delivered on the same day as the baseline measurements.

After the initial measurements, the educational intervention will be carried out for the patients in the pre-dialysis group and those in the dialysis group, which will last 5 monthly sessions lasting approximately 2 - 2.5 hours.The content of monthly educational sessions will be: Month 1: proteins (predialysis group), potassium (dialysis group) Month 2: Sodium and fluids (predialysis group), phosphorus (dialysis group) Month 3: Phosphorus (predialysis group), sodium and fluids (dialysis group) Month 4: Potassium (predialysis group), proteins (dialysis group) Month 5: Myths and facts about food (both groups)

Simultaneously to the educational program, in the intervention groups, sessions of a maximum of 5 patients will be held monthly for two hours with a group of clinical psychologists, made up of two people from the center for integral care of patients with diabetes. These sessions will be held on days different from the educational program. In each session the hospital anxiety and depression scale will be applied. The content of the psychological intervention is as follows: Month 1: Psychoeducation with the aim of making participants aware of the psychological aspects of renal disease, grief and the most common barriers to non-adherence to the diet plan, it will facilitate the understanding of the situation they are living and will favor the development of healthy behaviors. Month 2, 3 and 4: Identified barriers will be addressed and, based on this, goals will be established, specifying the behavior to be performed, including frequency, intensity or duration in a given context. In addition, problem-solving therapy will be provided to facilitate active coping that will be useful when facing chronic medical difficulties. Month 5: integrate the relapse prevention strategy, to identify and manage situations that may lead to abandoning new behaviors or adopting new risk behaviors.

After the end of the educational program and the psychological intervention, the patients' records will be reviewed again to extract the most recent biochemical parameters and measurements of dietary adherence, nutritional knowledge, nutritional status and quality of life will be performed for the second time in both the control and intervention groups.

Eligibility criteria: 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 \&lt; 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.

Primary outcomes:
measure: Patients´ dietary attitude
timeFrame: From enrollment to the end of the intervention at 5 months
measure: Dietary adherence
timeFrame: From enrollment to the end of the intervention at 5 months
measure: Nutritional knowledge
timeFrame: From enrollment to the end of the intervention at 5 months
Secondary outcomes:
measure: Muscle status
timeFrame: From enrollment to the end of the intervention at 5 months
measure: Muscle functionality
timeFrame: From enrollment to the end of the intervention at 5 months
measure: Nutritional status of predialysis patients
timeFrame: From enrollment to the end of the intervention at 5 months
measure: Nutritional status of dialysis patients
timeFrame: From enrollment to the end of the intervention at 5 months
measure: Patients´ quality of life
timeFrame: From enrollment to the end of the intervention at 5 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiránn
name: Ximena Atilano Carsi, PhD
role: PRINCIPAL_INVESTIGATOR
References: