Psychological Characteristics Involved in Dietary ComplianceKetoPsyNCT02345759
Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease
An observational study of Psychological Characteristics Involved in Dietary Compliance, run by Anemia Working Group Romania at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psychological Characteristics Involved in Dietary Compliance
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2013to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients, with stage 4-5ND CKD (estimated glomerular filtration by MDRD formula of less than 30 mL/min per year) included in the dietary intervention program of "Dr Carol Davila" Teaching Hospital of Nephrology coming for the scheduled visits between January the 1st and June the 30th, 2014 will be considered eligible. Those who will sign the informed consent will be included in the study; the specially-designed questionnaire will be administered. Simultaneously, their routine assesment, including the dietary compliance, manifestations of CKD and the nutritional status will be performed, as recommended by the Romanian Best Practice Guidelines for CKD [28].
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Cristina Drugau contact
Romania1 site, 1 recruiting
- Recruiting
Spitalul Clinic de Nefrologie "Dr Carol Davila"
Bucharest, 010731
Liliana Garneata, MD, PhD, 0722619358, lilianagarna@yahoo.com
Cristina Drugau, MD, cristina.drugau@yahoo.com
About this study
Official title: Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease
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.
Read the detailed 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.
- Keywords
- CKD patients, protein-restricted diets, compliance, psychological aspects
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Keto-diet group | Vegetarian very low protein regimen (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day. | |
| Conventional LPD group | 0.6 g/kg per day, including high biological value proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline
The decline in glomerular filtration rate (GFR)
Measured: 12 months
Psychological parameter - self-efficacy score
Self-efficacy score derives from the self-efficacy scale.
Measured: 12 months
Nitrogen balance (Serum urea level)
Serum urea level
Measured: 12 months
Metabolic acidosis (Serum bicarbonate level)
Serum bicarbonate level
Measured: 12 months
Calcium-phosphorus metabolism abnormalities (Serum calcium)
Serum calcium
Measured: 12 months
Calcium-phosphorus metabolism abnormalities (Serum phosphates level)
Serum phosphates level
Measured: 12 months
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.
Measured: 12 months
Mental status - vitality index
Vitality score derived from mental component of SF-36
Measured: 12 months
Psychological parameter -mental score
The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2013
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Characteristics Involved in Dietary ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anemia Working Group Romania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Mircescu, Professor of Nephrology, Study chair, Spitalul Clinic de Nefrologie "Dr Carol Davila"Liliana Garneata, MD, PhD, Study director, Spitalul Clinic de Nefrologie "Dr Carol Davila"Cristina Drugau, MD, Principal investigator, Spitalul Clinic de Nefrologie "Dr Carol Davila"Evy Dehelean, Psychologist, Principal investigator, International Health Care Systems Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345759
- Sponsor's protocol ID
- AWG 5/2014
- Acronym
- KetoPsy
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2014
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02345759
- Acronym / sponsor ID
- KetoPsy / AWG 5/2014
- Keywords
- CKD patients, protein-restricted diets, compliance, psychological aspects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Anemia Working Group RomaniaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto-diet group | – | –Vegetarian very low protein regimen (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day. |
| Conventional LPD group | – | –0.6 g/kg per day, including high biological value proteins |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients, with stage 4-5ND CKD (estimated glomerular filtration by MDRD formula of less than 30 mL/min per year) included in the dietary intervention program of "Dr Carol Davila" Teaching Hospital of Nephrology coming for the scheduled visits between January the 1st and June the 30th, 2014 will be considered eligible. Those who will sign the informed consent will be included in the study; the specially-designed questionnaire will be administered. Simultaneously, their routine assesment, including the dietary compliance, manifestations of CKD and the nutritional status will be performed, as recommended by the Romanian Best Practice Guidelines for CKD [28].
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance to the protein-restricted diet
Time frame: 12 months
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.
9 secondary outcomes
Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline
Time frame: 12 months
Psychological parameter - self-efficacy score
Time frame: 12 months
Nitrogen balance (Serum urea level)
Time frame: 12 months
Metabolic acidosis (Serum bicarbonate level)
Time frame: 12 months
Calcium-phosphorus metabolism abnormalities (Serum calcium)
Time frame: 12 months
Calcium-phosphorus metabolism abnormalities (Serum phosphates level)
Time frame: 12 months
Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire)
Time frame: 12 months
Mental status - vitality index
Time frame: 12 months
Psychological parameter -mental score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Drugau contact
Gabriel Mircescu, Professor of Nephrology study chair
Spitalul Clinic de Nefrologie "Dr Carol Davila"
Liliana Garneata, MD, PhD study director
Spitalul Clinic de Nefrologie "Dr Carol Davila"
Cristina Drugau, MD principal investigator
Spitalul Clinic de Nefrologie "Dr Carol Davila"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Characteristics Involved in Dietary Compliance, run by Anemia Working Group Romania at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liliana Garneata, MD, PhD (+40722619358, lilianagarna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to the protein-restricted diet (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.