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

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Specific dietary treatment and follow-up using coaching techniques
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Advanced CKD, diet, nutritional education, coaching, quality of life (QoL), nutritional status, functional capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Regional Universitario de Málaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: nutritional education program

Control Group

Arm Description

Specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program

Dietary and general lifestyle recommendations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
BMI (body mass index) changes
Measured by body composition analysis
Change in weight
Weight in kg
Change in fat free body mass
Fat free body mass in kg assessed by bioelectrical impedance analysis
Change in upper arm circumference
circumference in cm
Change in arm muscle circumference
circumference in cm
waist circumference
circumference in cm
Change in serum potassium concentration (assess kidney function)
serum potassium in mEq/l
Change in serum phosphorus concentration (assess kidney function)
serum phosphorus mg/dl
Change in glomerular filtration (assess kidney function)
Calculated with the formula of CKD-EPI and MDRD and measured in ml/ min/ 1.73 m2
Change in serum albumin concentration
Serum albumin in g/dl
Change in serum prealbumin concentration
Serum prealbumin in mg/dl
Change in cholesterol concentration
Serum cholesterol in mg/dl
Change in HDL concentration
Serum HDL in mg/dl
Change in LDL concentration
Serum LDL in mg/dl
Change in TG concentration
Serum TG in mg/dl
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
Changes in blood cells
Blood count
Change in iron concentration
Serum iron in μg/dl
Change in ferritin concentration
Serum ferritin in ng/ml
Change in uric acid concentration
Serum uric acid in mg/dl
Change in urea concentration
Serum uric acid in mg/dl
Change in magnesium concentration
Serum magnesium in mg/dl
Change in calcium concentration
Serum calcium in mg/dl
Change in intact parathyroid hormone (PTHi) concentration
Serum intact parathyroid hormone (PTHi) in pg/ml
Changes in vitamin D
Serum vitamin D in ng/ml
Changes in metabolic control
Measured as HbA1c (glycated hemoglobin)
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.
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.
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.
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.
Change from Handgrip Strength
Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)
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.
Change in handgrip strength
Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.
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.
Diet composition: PREDIMED test (Prevention with Mediterranean Diet)
Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)

Full Information

First Posted
April 8, 2021
Last Updated
July 19, 2023
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05072574
Brief Title
Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease
Acronym
ERCANUT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Advanced CKD, diet, nutritional education, coaching, quality of life (QoL), nutritional status, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: nutritional education program
Arm Type
Experimental
Arm Description
Specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Dietary and general lifestyle recommendations
Intervention Type
Other
Intervention Name(s)
Specific dietary treatment and follow-up using coaching techniques
Intervention Description
Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program
Primary Outcome Measure Information:
Title
Assess the clinical response after the quality of life intervention
Description
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.
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
Assess the clinical response after intervention in the management of CKD
Description
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.
Time Frame
From baseline to week 12
Title
Assess the clinical response after the intervention in knowledge about the disease
Description
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.
Time Frame
From baseline to week 12
Title
BMI (body mass index) changes
Description
Measured by body composition analysis
Time Frame
From baseline to week 12
Title
Change in weight
Description
Weight in kg
Time Frame
From baseline to week 12
Title
Change in fat free body mass
Description
Fat free body mass in kg assessed by bioelectrical impedance analysis
Time Frame
From baseline to week 12
Title
Change in upper arm circumference
Description
circumference in cm
Time Frame
From baseline to week 12
Title
Change in arm muscle circumference
Description
circumference in cm
Time Frame
From baseline to week 12
Title
waist circumference
Description
circumference in cm
Time Frame
From baseline to week 12
Title
Change in serum potassium concentration (assess kidney function)
Description
serum potassium in mEq/l
Time Frame
From baseline to week 12
Title
Change in serum phosphorus concentration (assess kidney function)
Description
serum phosphorus mg/dl
Time Frame
From baseline to week 12
Title
Change in glomerular filtration (assess kidney function)
Description
Calculated with the formula of CKD-EPI and MDRD and measured in ml/ min/ 1.73 m2
Time Frame
From baseline to week 12
Title
Change in serum albumin concentration
Description
Serum albumin in g/dl
Time Frame
From baseline to week 12
Title
Change in serum prealbumin concentration
Description
Serum prealbumin in mg/dl
Time Frame
From baseline to week 12
Title
Change in cholesterol concentration
Description
Serum cholesterol in mg/dl
Time Frame
From baseline to week 12
Title
Change in HDL concentration
Description
Serum HDL in mg/dl
Time Frame
From baseline to week 12
Title
Change in LDL concentration
Description
Serum LDL in mg/dl
Time Frame
From baseline to week 12
Title
Change in TG concentration
Description
Serum TG in mg/dl
Time Frame
From baseline to week 12
Title
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Description
Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Time Frame
From baseline to week 12
Title
Changes in blood cells
Description
Blood count
Time Frame
From baseline to week 12
Title
Change in iron concentration
Description
Serum iron in μg/dl
Time Frame
From baseline to week 12
Title
Change in ferritin concentration
Description
Serum ferritin in ng/ml
Time Frame
From baseline to week 12
Title
Change in uric acid concentration
Description
Serum uric acid in mg/dl
Time Frame
From baseline to week 12
Title
Change in urea concentration
Description
Serum uric acid in mg/dl
Time Frame
From baseline to week 12
Title
Change in magnesium concentration
Description
Serum magnesium in mg/dl
Time Frame
From baseline to week 12
Title
Change in calcium concentration
Description
Serum calcium in mg/dl
Time Frame
From baseline to week 12
Title
Change in intact parathyroid hormone (PTHi) concentration
Description
Serum intact parathyroid hormone (PTHi) in pg/ml
Time Frame
From baseline to week 12
Title
Changes in vitamin D
Description
Serum vitamin D in ng/ml
Time Frame
From baseline to week 12
Title
Changes in metabolic control
Description
Measured as HbA1c (glycated hemoglobin)
Time Frame
From baseline to week 12
Title
Assess changes in the degree of depression and / or anxiety
Description
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.
Time Frame
From baseline to week 12
Title
Assess the clinical response after the intervention on functional capacity
Description
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.
Time Frame
From baseline to week 12
Title
Assess on functional capacity
Description
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.
Time Frame
From baseline to week 12
Title
Changes on functional capacity: International Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
From baseline to week 12
Title
Change from Handgrip Strength
Description
Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)
Time Frame
From baseline to week 12
Title
Characterize exercise participant behavior
Description
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.
Time Frame
From baseline to week 12
Title
Change in handgrip strength
Description
Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.
Time Frame
From baseline to week 12
Title
Changes the clinical response after the intervention in blood pressure figures (mmHg).
Description
Assess if syastolic and diastolic pressure improves after training and at 6 months of follow-up.
Time Frame
From baseline to week 12
Title
Diet composition: PREDIMED test (Prevention with Mediterranean Diet)
Description
Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)
Time Frame
From baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira, MD, PhD
Organizational Affiliation
Hospital Regional Universitario de Málaga - FIMABIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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