Outcomes to the Nutritional Need of Patients With Parkinson's Disease

NCT ID: NCT04983290

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-05-30

Brief 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 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

Conditions

Deglutition Disorders; Parkinson Disease; Nursing; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intervention

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.

Group Type: EXPERIMENTAL

weancare-domus

Intervention Type: DIETARY_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

control

The control group will continue with its own feeding for the entire observation period of the experimental group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

weancare-domus

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Terminally ill subjects for pathology
• Subjects with severe disphagia and indication to artificial nutrition (enteral/parenteral)
• Severe renal, liver and respiratory failure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale 3 Genovese

OTHER

Sponsor Role: collaborator

Milko Zanini

OTHER

Sponsor Role: lead

Responsible Party

Milko Zanini

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marina Simonini, Dr

Role: PRINCIPAL_INVESTIGATOR

Asl 3 genovese

Locations

ASL 3 Genovese Struttura Complessa Recupero e Rieducazione Funzionale Ospedale "La Colletta" Via del Giappone, 5 - Arenzano (GE)

Genova, , Italy

Countries

Italy

Central Contacts

Annamaria Bagnasco, Prof

Role: CONTACT

annamaria.bagnasco@unige.it

+3901035385

Milko Zanini, Dr

Role: CONTACT

milko.zanini@edu.unige.it

+3901035385

Facility Contacts

Marina Simonini, PI

Role: primary

Marina.Simonini@asl3.liguria.it

+390108498067

Antonella Giusti, I

Role: backup

Antonella.Giusti@asl3.liguria.it

+390108498067

Other Identifiers

W-DOMUS-PARK/2021

Identifier Type: -

Identifier Source: org_study_id