Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351007
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-07
Brief Title:
Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients EPAK
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPAK
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
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 patients 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 315 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 groupThe 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 - 25 hoursThe 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
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 groupThe 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 - 25 hoursThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None