Deglutition DisordersW-DomusNCT04983290
Outcomes to the Nutritional Need of Patients With Parkinson's Disease
A study testing weancare-domus in people with Deglutition Disorders and Parkinson Disease, run by Milko Zanini at 1 site in Italy.
Trial summary
The intervention involves the identification of 140 patients (70 per group), fed throughout the duration of the study with the two different solutions indicated. The subject will be interviewed by identified and trained personnel in order to collect the information and data required by the study with frequency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Parkinson Disease, Nursing
- What is being tested?
- weancare-domus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 30 May 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of FOIS-based disphagy or Smithard test (3 oz swallow test) (2 - 3) or previous FEES diagnosis
- classification of the functional oral intake scale (FOIS) level of disphagy in classes 4 or 5 (or levels 2-3 on specific clinical indication)
- Belonging to one of the territorial structures for the Management of Parkinson's Disease in the territory of Genoa
Who cannot join
- Terminally ill subjects for pathology
- Subjects with severe disphagia and indication to artificial nutrition (enteral/parenteral)
- Severe renal, liver and respiratory failure
- Disphagy level classifications inconsistent with inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASL 3 Genovese Struttura Complessa Recupero e Rieducazione Funzionale Ospedale "La Colletta" Via del Giappone, 5 - Arenzano (GE)
Genova, 16132
Marina Simonini, PI, +390108498067, Marina.Simonini@asl3.liguria.it
Antonella Giusti, I, +390108498067, Antonella.Giusti@asl3.liguria.it
About this study
Official title: Clinical Trial to Assess the Effectiveness of the Food Plan Consisting of Products With Modified Consistency Called (Weancare-Domus) in Changing the Quality of Life in Patients With Parkinson's Disease
The intervention involves the identification of 140 patients (70 per group), fed throughout the duration of the study with the two different solutions indicated. The subject will be interviewed by identified and trained personnel in order to collect the information and data required by the study with frequency indicated for the individual evaluation sheets. The subject himself will be provided with all the contact and availability information of the referents of the firm for the purpose of requesting information or reporting events. The subject in the studio will be contacted weekly in order to evaluate the trend by the study referents, according to his availability, and personally interviewed by staff belonging to the research group.
Read the detailed description
Non-motor symptomatology in Parkinson's disease (PD) is related to the quality of life of patients . Malnutrition in the subject with Parkinson's is a still relevant variable that hesitates in sarcopenia and increased motor deficits in relation to loss of muscle mass and energy deficit. Guidelines from the European Society for Clinical Nutrition and Metabolism (ESPEN) recommend monitoring and implementing interventions in the presence of weight loss or body mass.
Disphagia is a syndrome common in Parkinson's patients, even in the early stages of the pathology. The study by Pflug and collaborators showed that only 5% of the patients observed were completely free from swallowing deficiency, while in 55% of subjects (66/119) aspiration or penetration of food and liquids in the airways were reported regardless of the stage of illness. Several studies, cited by Curtis and collaborators, show that the prevalence of disphagia varies between 11 and 97% of patients during the course of the disease. This condition affects both food safety, with the risk of aspiration and ab-ingestis, and malnutrition conditions, hydration deficiency, also affecting the overall survival of patients in relation to the onset of pneumonia.
From a nursing point of view, great interest has the integrated nutritional indices, easy and quick-to-use tools, which manage to determine promptly the presence and risk of malnutrition and which can be used daily in the patient's evaluation. The most suitable is the Mini Nutritional Assessment (MNA), which determines the risk of malnutrition before modification of biochemical parameters. MNA has a sensitivity of 96% and a specificity of 97%.
The adoption of scales that evaluate non-motorcycle-related symptoms helps to identify the sindromic dimension of the pathology, highlighting its components that impact the overall quality of life.
Patients who follow a level 3 and 4 modified texture diet of the IDDSI Framework scheme frequently encounter an overall reduction in energy and protein intake, determined by the way the meal is prepared in self-production, associated with an often drastic reduction in fluid intake with consequences in both systemic and specific terms for the gastrointestinal tract. Monitoring liquids introduced by subjects with swallowing deficiency is a Grade B recommendation in the ESPEN guidelines.
Disphagia is a frequent condition in the subject with Parkinson's disease, particularly in the advanced stages, recent studies begin to show a decay in the safety of swallowing and maintenance in the airway in these subjects, even in relatively early stages of the disease.
Therefore, the application of a specific nutritional program for patients with swallowing problems is recommended in the prevention of malnutrition in patients with Parkinson's disease. Previous studies showed the rapid reversibility of malnutrition in hospitalized elderly subjects with cognitive and functional impairment if enrolled in a specific nutritional program.
In view of the strong impact that eating difficulties have on the state of health of parkinson's disease patients suffering from disphagia, the widespread spread of dietary frailties related to the various degrees of disphagia and the importance that patients with slight difficulty swallowing or chewing do not develop further pathologies related to a nutritional deficit , it is necessary to study the effectiveness of specific nutritional programs developed to meet the person's need for nutrition The aim of the study is to improve the nursing-care management of Parkinson's disease patients with disphagia
- Conditions
- Deglutition Disorders, Parkinson Disease, Nursing, Quality of Life
- Being tested
- weancare-domus
- Medical subject headings
- Deglutition Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weancare-domusDietary supplement
Participants belonging to the experimental group will receive at home a set of foods that allows to receive the right amount of proteins and energy in a modified texture form to be prepared by themselves or by their caregivers
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The participating subjects belonging to the experimental group, will receive at home a set of foods with modified textures that allow the patient to feed for the observation period of 4 months, will also be followed by the dietary service of the center and by personnel identified within the protocol in order to verify compliance, liability and information regarding the evaluation scales involved in the project. Receives: Dietary Supplement: weancare-domus |
| control | No intervention | The control group will continue with its own feeding for the entire observation period of the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-motor symptomatology change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - NNMS)
Novel Non-Motor Symptoms Scale for Parkinson's Disease includes 9 domains and 30 items.
Each symptom scored with respect to:
Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.
Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
Measured: 4 months
Secondary outcomes (1)
Suction and ab-ingestis events related to textured food change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - Domain 6: Gastrointestinal tract)
Novel Non-Motor Symptoms Scale for Parkinson's Disease - Domain 6: Gastrointestinal tract includes 3 items.
Each symptom scored with respect to:
Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.
Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
- Does the patient dribble saliva during the day? 20. Does the patient have difficulty swallowing? 21. Does the patient suffer from constipation? (Bowel action less than three times weekly)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized nutraceutical clinical trial controlled with cross-over design on two groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milko Zanini
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Locale 3 Genovese
- Responsible party
- Sponsor-investigator, Milko Zanini, University of Genova
- Investigators
- Marina Simonini, Dr, Principal investigator, Asl 3 genovese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983290
- Sponsor's protocol ID
- W-DOMUS-PARK/2021
- Acronym
- W-Domus
- Status last verified
- Sep 2021
- First submitted
- 9 Jun 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Effectiveness of the Food Plan Consisting of Products With Modified Consistency Called (Weancare-Domus) in Changing the Quality of Life in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04983290
- Acronym / sponsor ID
- W-Domus / W-DOMUS-PARK/2021
- Conditions
- Deglutition Disorders, Parkinson Disease, Nursing, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Milko ZaniniUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Locale 3 Genovese
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 30 Jul 2021 (actual)
- 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.
The intervention involves the identification of 140 patients (70 per group), fed throughout the duration of the study with the two different solutions indicated. The subject will be interviewed by identified and trained personnel in order to collect the information and data required by the study with frequency indicated for the individual evaluation sheets. The subject himself will be provided with all the contact and availability information of the referents of the firm for the purpose of requesting information or reporting events. The subject in the studio will be contacted weekly in order to evaluate the trend by the study referents, according to his availability, and personally interviewed by staff belonging to the research group.
Detailed description
Non-motor symptomatology in Parkinson's disease (PD) is related to the quality of life of patients . Malnutrition in the subject with Parkinson's is a still relevant variable that hesitates in sarcopenia and increased motor deficits in relation to loss of muscle mass and energy deficit. Guidelines from the European Society for Clinical Nutrition and Metabolism (ESPEN) recommend monitoring and implementing interventions in the presence of weight loss or body mass.
Disphagia is a syndrome common in Parkinson's patients, even in the early stages of the pathology. The study by Pflug and collaborators showed that only 5% of the patients observed were completely free from swallowing deficiency, while in 55% of subjects (66/119) aspiration or penetration of food and liquids in the airways were reported regardless of the stage of illness. Several studies, cited by Curtis and collaborators, show that the prevalence of disphagia varies between 11 and 97% of patients during the course of the disease. This condition affects both food safety, with the risk of aspiration and ab-ingestis, and malnutrition conditions, hydration deficiency, also affecting the overall survival of patients in relation to the onset of pneumonia.
From a nursing point of view, great interest has the integrated nutritional indices, easy and quick-to-use tools, which manage to determine promptly the presence and risk of malnutrition and which can be used daily in the patient's evaluation. The most suitable is the Mini Nutritional Assessment (MNA), which determines the risk of malnutrition before modification of biochemical parameters. MNA has a sensitivity of 96% and a specificity of 97%.
The adoption of scales that evaluate non-motorcycle-related symptoms helps to identify the sindromic dimension of the pathology, highlighting its components that impact the overall quality of life.
Patients who follow a level 3 and 4 modified texture diet of the IDDSI Framework scheme frequently encounter an overall reduction in energy and protein intake, determined by the way the meal is prepared in self-production, associated with an often drastic reduction in fluid intake with consequences in both systemic and specific terms for the gastrointestinal tract. Monitoring liquids introduced by subjects with swallowing deficiency is a Grade B recommendation in the ESPEN guidelines.
Disphagia is a frequent condition in the subject with Parkinson's disease, particularly in the advanced stages, recent studies begin to show a decay in the safety of swallowing and maintenance in the airway in these subjects, even in relatively early stages of the disease.
Therefore, the application of a specific nutritional program for patients with swallowing problems is recommended in the prevention of malnutrition in patients with Parkinson's disease. Previous studies showed the rapid reversibility of malnutrition in hospitalized elderly subjects with cognitive and functional impairment if enrolled in a specific nutritional program.
In view of the strong impact that eating difficulties have on the state of health of parkinson's disease patients suffering from disphagia, the widespread spread of dietary frailties related to the various degrees of disphagia and the importance that patients with slight difficulty swallowing or chewing do not develop further pathologies related to a nutritional deficit , it is necessary to study the effectiveness of specific nutritional programs developed to meet the person's need for nutrition The aim of the study is to improve the nursing-care management of Parkinson's disease patients with disphagia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized nutraceutical clinical trial controlled with cross-over design on two groups
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Dietary Supplement: weancare-domusThe participating subjects belonging to the experimental group, will receive at home a set of foods with modified textures that allow the patient to feed for the observation period of 4 months, will also be followed by the dietary service of the center and by personnel identified within the protocol in order to verify compliance, liability and information regarding the evaluation scales involved in the project. |
| control | No intervention | –The control group will continue with its own feeding for the entire observation period of the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of FOIS-based disphagy or Smithard test (3 oz swallow test) (2 - 3) or previous FEES diagnosis
- classification of the functional oral intake scale (FOIS) level of disphagy in classes 4 or 5 (or levels 2-3 on specific clinical indication)
- Belonging to one of the territorial structures for the Management of Parkinson's Disease in the territory of Genoa
Key exclusion criteria (4 listed)
- Terminally ill subjects for pathology
- Subjects with severe disphagia and indication to artificial nutrition (enteral/parenteral)
- Severe renal, liver and respiratory failure
- Disphagy level classifications inconsistent with inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weancare-domusParticipants belonging to the experimental group will receive at home a set of foods that allows to receive the right amount of proteins and energy in a modified texture form to be prepared by themselves or by their caregivers | Dietary supplement | intervention |
Primary outcome
Non-motor symptomatology change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - NNMS)
Time frame: 4 months
Novel Non-Motor Symptoms Scale for Parkinson's Disease includes 9 domains and 30 items. Each symptom scored with respect to: Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
1 secondary outcome
Suction and ab-ingestis events related to textured food change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - Domain 6: Gastrointestinal tract)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Marina Simonini, Dr principal investigator
Asl 3 genovese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weancare-domus in people with Deglutition Disorders and Parkinson Disease, run by Milko Zanini at 1 site in Italy.
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 3 inclusion and 4 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 28 Sep 2021. 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 Italy. 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 Annamaria Bagnasco, Prof (+3901035385, annamaria.bagnasco@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-motor symptomatology change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - NNMS) (time frame: 4 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 28 Sep 2021.