Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease

Study Overview
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Brief Summary
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This study evaluates the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

Detailed Description
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Randomized study including two parallel groups: patients from the advanced chronic kidney disease (CKD) consulting room of the Malaga University Regional Hospital and controls. The main objective is to assess the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit. Both groups will be composed of 54 participants. The control group will be provided general dietary and lifestyle recommendations (standard procedure in the nephrology consulting room), whereas the intervention group will receive treatment and individualized dietary follow-up using coaching techniques, supported by information and communication technologies, and will participate in a nutritional education program composed of four on-line sessions. Two visits (basal and three months after) will be scheduled during the study to obtain and analyse the data. Moreover, in these visits researchers will collect a blood sample in order to perform an assessment of the metabolism, inflammation, and oxidation, and a stool sample in order to evaluate the gut microbiota.

Official Title
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Assessment of Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease (CKD) After the Implementation of a Nutritional Education Plan and Individualized Dietary Intervention

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: Specific dietary treatment and follow-up using coaching techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients >18 years old with advanced CKD (GFR <30ml/min) starting follow-up in the advanced CKD consulting room of the Malaga University Regional Hospital and who clearly understand the study and give their informed consent. Exclusion Criteria: Patients presenting any of these conditions: Active cancer Being already participants of another study that may affect the results Pregnancy or possible pregnancy Informed consent refusal Hospital admission during one month previous to the study Severe mental disorders (SMD), prolonged mental disorders involving a high level of disability and social dysfunction, which requires attendance by the mental health and social care network Alcohol or any other substance abuse that, in the researcher's opinion, may interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in a 1:1 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: nutritional education program<br>Specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program | Other: Specific dietary treatment and follow-up using coaching techniques<br>* Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program<br>|
| No Intervention: Control Group<br>Dietary and general lifestyle recommendations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the clinical response after the quality of life intervention | Kidney Disease and Quality of Life test (KDQOL-36). The generic component of the KDQOL-36 (items 1-12) is the SF-12, which allows obtaining 2 general scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The specific component of the KDQOL-36 (items 13-36), allows obtaining the scores of the specific subscales for the disease. | From baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the clinical response after intervention in the management of CKD | Self-Efficacy for Managing Chronic Disease test. The Self-Efficacy Scale for the Management of Chronic Diseases (SEMCD) is made up of 6 items on an analog scale, ranging from 1 (not at all sure) to 10 (totally safe). The Spanish version (SEMCD-S) consists of 4 items. A higher number means greater self-efficacy. The scale score is the mean of the items. | From baseline to week 12 | 
| Assess the clinical response after the intervention in knowledge about the disease | Kidney Disease Knowledge Survey test. The Kidney Disease Knowledge Survey (KiKS) instrument consists of 28 items and aims to assess specific knowledge about chronic kidney disease in non-dialysis patients. One point is considered for each correct answer and zero for the incorrect one. The total score is calculated by adding all the correct points and divided by 28, obtaining a value from 0 to 1, with 1 being the highest level of knowledge. | From baseline to week 12 | 
| BMI (body mass index) changes | Measured by body composition analysis | From baseline to week 12 | 
| Change in weight | Weight in kg | From baseline to week 12 | 
| Change in fat free body mass | Fat free body mass in kg assessed by bioelectrical impedance analysis | From baseline to week 12 | 
| Change in upper arm circumference | circumference in cm | From baseline to week 12 | 
| Change in arm muscle circumference | circumference in cm | From baseline to week 12 | 
| waist circumference | circumference in cm | From baseline to week 12 | 
| Change in serum potassium concentration (assess kidney function) | serum potassium in mEq/l | From baseline to week 12 | 
| Change in serum phosphorus concentration (assess kidney function) | serum phosphorus mg/dl | From baseline to week 12 | 
| Change in glomerular filtration (assess kidney function) | Calculated with the formula of CKD-EPI and MDRD and measured in ml/ min/ 1.73 m2 | From baseline to week 12 | 
| Change in serum albumin concentration | Serum albumin in g/dl | From baseline to week 12 | 
| Change in serum prealbumin concentration | Serum prealbumin in mg/dl | From baseline to week 12 | 
| Change in cholesterol concentration | Serum cholesterol in mg/dl | From baseline to week 12 | 
| Change in HDL concentration | Serum HDL in mg/dl | From baseline to week 12 | 
| Change in LDL concentration | Serum LDL in mg/dl | From baseline to week 12 | 
| Change in TG concentration | Serum TG in mg/dl | From baseline to week 12 | 
| Changes in plasma levels of high sensitivity C reactive protein (hs-CRP) | Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl | From baseline to week 12 | 
| Changes in blood cells | Blood count | From baseline to week 12 | 
| Change in iron concentration | Serum iron in μg/dl | From baseline to week 12 | 
| Change in ferritin concentration | Serum ferritin in ng/ml | From baseline to week 12 | 
| Change in uric acid concentration | Serum uric acid in mg/dl | From baseline to week 12 | 
| Change in urea concentration | Serum uric acid in mg/dl | From baseline to week 12 | 
| Change in magnesium concentration | Serum magnesium in mg/dl | From baseline to week 12 | 
| Change in calcium concentration | Serum calcium in mg/dl | From baseline to week 12 | 
| Change in intact parathyroid hormone (PTHi) concentration | Serum intact parathyroid hormone (PTHi) in pg/ml | From baseline to week 12 | 
| Changes in vitamin D | Serum vitamin D in ng/ml | From baseline to week 12 | 
| Changes in metabolic control | Measured as HbA1c (glycated hemoglobin) | From baseline to week 12 | 
| Assess changes in the degree of depression and / or anxiety | HADS depression and anxiety symptoms screening test. It is a self-administered scale with 14 items divided into 2 subscales (anxiety and depression) whose maximum score is 21 points for each of them. Based on the score obtained, the patients can be classified as normal (<7), doubtful (between 8 and 10) and potential clinical case (≥ 11). The score is referred to the last week. | From baseline to week 12 | 
| Assess the clinical response after the intervention on functional capacity | Scale of autonomy for activities of daily life Barthel test. This test measures the capacity of the person to carry out ten basic activities of daily life, obtaining a quantitative estimate of the degree of dependence of the subject. The range of possible IB values is between 0 and 100, with 5-point intervals for the original version. The closer a subject's score is to 0, the more dependency they have; the closer to 100 the more independence. | From baseline to week 12 | 
| Assess on functional capacity | Physical activity test Short Physical Performance Battery SPPB. This in turn includes 3 tests: balance, gait speed and getting up and sitting in a chair 5 times. Each test is scored from 0 (worst performance) to 4 (best performance): for the balance test according to a hierarchical combination of performance in the 3 component subtests and for the other 2 tests a score of 0 is assigned to those who do not complete or they attempt the task and scores from 1 to 4 based on the time spent. In addition, a total score for the entire battery is obtained, which is the sum of the 3 tests and ranges from 0 to 12. | From baseline to week 12 | 
| Changes on functional capacity: International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey consists of 27 questions and 5 parts. | From baseline to week 12 | 
| Change from Handgrip Strength | Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg) | From baseline to week 12 | 
| Characterize exercise participant behavior | International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day. It evaluates three characteristics of physics (PA): intensity (mild, moderate or vigorous), frequency (days per week) and duration (time per day). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Index Units) per minute and week. | From baseline to week 12 | 
| Change in handgrip strength | Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer. | From baseline to week 12 | 
| Changes the clinical response after the intervention in blood pressure figures (mmHg). | Assess if syastolic and diastolic pressure improves after training and at 6 months of follow-up. | From baseline to week 12 | 
| Diet composition: PREDIMED test (Prevention with Mediterranean Diet) | Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence) | From baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced CKD, diet, nutritional education, coaching, quality of life (QoL), nutritional status, functional capacity