Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease

Psychological Characteristics Involved in Dietary Compliance Clinical Trial

— KetoPsy  

Official title:

Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345759
• Other study ID #: AWG 5/2014
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: August 2018
• Source: Anemia Working Group Romania
• Contact: Liliana Garneata, MD, PhD
• Phone: +40722619358
• Email: lilianagarna[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dietary management of CKD patients proved important to postpone dialysis. Long-term compliance to protein-restricted diets was discussed. Psychological aspects involved in certain dietary behaviour have never been studied.

Description:

The interest in dietary management resurged, since the high prevalence of revealed a major impact not only on morbidity, mortality, social activities and patients' quality of life, but also on health budget.

Although protein-restricted diets are used for more than a century in patients with advanced Chronic Kidney Disease (CKD), their efficacy and safety is still debatable. Enough evidence has being accumulated on their role in postponing dialysis initiation in compliant patients. Consequently, the long-term compliance to the diet is discussed. Psychological aspects of compliant patients are certainly involved. Identification of certain psychological predictors of dietary compliance could help to select the patients who are more likely to be compliant and therefore to benefit from such an intervention. Moreover, short-term or long-term psychological intervention addressing these factors could increase patient long-term compliance.

Accordingly, we are aiming to evaluate psychological characteristics of Chronic Kidney Disease patients in relation with their compliance to protein-restricted regimens.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• adult patients

• stage 4+ CKD

• good nutritional status (Subjective Global Assessment score A/B and serum albumin =3.5 g/dL)

• declared potentially good compliance with a low protein diet and agreed to follow the monitoring schedule are considered for the program

Exclusion Criteria:

• poorly controlled arterial blood pressure (=145/85 mm Hg)

• uncontrolled diabetes mellitus

• other relevant comorbidities (heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)

• uremic complications (pericarditis, polyneuropathy)

• feeding inability (anorexia, nausea)

Related Conditions & MeSH terms

• Kidney Diseases
• Psychological Characteristics Involved in Dietary Compliance
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Romania	Spitalul Clinic de Nefrologie "Dr Carol Davila"	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Anemia Working Group Romania

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol)	Parameters of nutritional status are predefined as safety parameters. Subjective Global Assessment anthropometric markers, and biochemical parameters	12 months
Primary	Compliance to the protein-restricted diet	The compliance to the diet is appreciated to be good if both the achieved protein intake and the achieved energy is in the range of ±10% of the recommended values.	12 months
Secondary	Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline	The decline in glomerular filtration rate (GFR)	12 months
Secondary	Psychological parameter - self-efficacy score	Self-efficacy score derives from the self-efficacy scale.	12 months
Secondary	Nitrogen balance (Serum urea level)	Serum urea level	12 months
Secondary	Metabolic acidosis (Serum bicarbonate level)	Serum bicarbonate level	12 months
Secondary	Calcium-phosphorus metabolism abnormalities (Serum calcium)	Serum calcium	12 months
Secondary	Calcium-phosphorus metabolism abnormalities (Serum phosphates level)	Serum phosphates level	12 months
Secondary	Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire)	Sub-scores derived from illness perception questionnaire: the higher this score, the worse is patient's perception on the disease.	12 months
Secondary	Mental status - vitality index	Vitality score derived from mental component of SF-36	12 months
Secondary	Psychological parameter -mental score	The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours.	12 months