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

NCT04983290 | Unknown

• 1 other identifier: W-DOMUS-PARK/2021
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorders; Parkinson Disease; Nursing; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  4 months

Other Outcomes (12)

• functional parameter related to malnutrition change: Gait speed

  4 months

• functional parameter related to malnutrition change: grip strength

  4 months

• functional parameter related to malnutrition change: muscle mass

  4 months

Study Arms (2)

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.

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.

Interventions

weancare-domus 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

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milko Zanini: lead
• Azienda Sanitaria Locale 3 Genovese: collaborator

Study Sites (1)

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

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Deglutition Disorders; Parkinson Disease

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Marina Simonini, Dr

  Asl 3 genovese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Bagnasco, Prof

CONTACT

+3901035385; annamaria.bagnasco@unige.it

Milko Zanini, Dr

CONTACT

+3901035385; milko.zanini@edu.unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Model Details: Randomized nutraceutical clinical trial controlled with cross-over design on two groups

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 30, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: May 30, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)