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

Chronic Kidney Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072574
• Other study ID #: ACKD
• Status: Completed
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Specific dietary treatment and follow-up using coaching techniques
Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	BMI (body mass index) changes	Measured by body composition analysis	From baseline to week 12
Secondary	Change in weight	Weight in kg	From baseline to week 12
Secondary	Change in fat free body mass	Fat free body mass in kg assessed by bioelectrical impedance analysis	From baseline to week 12
Secondary	Change in upper arm circumference	circumference in cm	From baseline to week 12
Secondary	Change in arm muscle circumference	circumference in cm	From baseline to week 12
Secondary	waist circumference	circumference in cm	From baseline to week 12
Secondary	Change in serum potassium concentration (assess kidney function)	serum potassium in mEq/l	From baseline to week 12
Secondary	Change in serum phosphorus concentration (assess kidney function)	serum phosphorus mg/dl	From baseline to week 12
Secondary	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
Secondary	Change in serum albumin concentration	Serum albumin in g/dl	From baseline to week 12
Secondary	Change in serum prealbumin concentration	Serum prealbumin in mg/dl	From baseline to week 12
Secondary	Change in cholesterol concentration	Serum cholesterol in mg/dl	From baseline to week 12
Secondary	Change in HDL concentration	Serum HDL in mg/dl	From baseline to week 12
Secondary	Change in LDL concentration	Serum LDL in mg/dl	From baseline to week 12
Secondary	Change in TG concentration	Serum TG in mg/dl	From baseline to week 12
Secondary	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
Secondary	Changes in blood cells	Blood count	From baseline to week 12
Secondary	Change in iron concentration	Serum iron in µg/dl	From baseline to week 12
Secondary	Change in ferritin concentration	Serum ferritin in ng/ml	From baseline to week 12
Secondary	Change in uric acid concentration	Serum uric acid in mg/dl	From baseline to week 12
Secondary	Change in urea concentration	Serum uric acid in mg/dl	From baseline to week 12
Secondary	Change in magnesium concentration	Serum magnesium in mg/dl	From baseline to week 12
Secondary	Change in calcium concentration	Serum calcium in mg/dl	From baseline to week 12
Secondary	Change in intact parathyroid hormone (PTHi) concentration	Serum intact parathyroid hormone (PTHi) in pg/ml	From baseline to week 12
Secondary	Changes in vitamin D	Serum vitamin D in ng/ml	From baseline to week 12
Secondary	Changes in metabolic control	Measured as HbA1c (glycated hemoglobin)	From baseline to week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Handgrip Strength	Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)	From baseline to week 12
Secondary	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
Secondary	Change in handgrip strength	Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.	From baseline to week 12
Secondary	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
Secondary	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