Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake

NCT05898139 | Completed

• 2 other identifiers: RC31/22/05272023-A00393-42
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to describe strategies (verbal, non-verbal (gesture, intonation), and environmental), designed and used by the assisting/aided dyad to feed a dysphagic dependent person by articulating the safe and hedonic dimensions in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal

Conditions

Parkinson Disease; Deglutition Disorders

Keywords

Dysphagia; Assistance feeding; Parkinson disease; Caregivers; Mealtime

Outcome Measures

Primary Outcomes (1)

• Strategies description

  Description of the strategies designed and used by the assisting/aided dyad to feed dysphagic patients to perform the hand-to-mouth gesture in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal, using filmed data and semi-directional interviews.

  13 months

Secondary Outcomes (5)

• Description of the perception of meal time, patient's point of view

  13 months

• Description of the perception of meal time, helper's point of view

  13 months

• Description of quality of life related to meal time

  13 months

• Identification of specific needs for educational programmes

  13 months

• Description of strategies put in place during meal time

  13 months

Study Arms (1)

Assisting (caregiver) / aided (patient with Parkinsonian syndrome) dyad

The dyad will be filmed during a meal and an interview with the sick person and his caregiver will be carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with typical or atypical parkinsonian syndrome and their caregiver

You may qualify if:

• Patient with typical or atypical Parkinsonian syndrome, collected in the medical record
• Indication of swallowing disorders or dysphagia, according to item 2.3 chewing and swallowing, part II of the MSD/UPDRS scale or collection in the medical record
• Person dependent on food (according to MDS/UPDRS - food tasks item, part II, 2.4 ≥ 2, to be help to cut food punctually
• Having a usual caregiver present for the meal.
• Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

• Individuals whose cognitive state does not allow simple questions to be answered, as judged by the neurologist
• Person fed exclusively by enteral nutrition.
• Patient who refuses to be filmed
• For caregivers:
• caregiver of the patient for at least 2 months for the taking of meal
• Person with French language to answer the questions of the interview
• Patient who refuses to be filmed
• Protected patient: under guardianship, trusteeship or other legal protection, deprived of freedom by judicial or administrative decision

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital, Parkinson center

Toulouse, Haute-Garonne, 31059, France

Location

Related Publications (17)

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  PMID: 34417870 BACKGROUND

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  PMID: 30902528 BACKGROUND

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  PMID: 30660444 BACKGROUND

• Liu W, Batchelor M, Williams K. Ease of use, feasibility and inter-rater reliability of the refined Cue Utilization and Engagement in Dementia (CUED) mealtime video-coding scheme. J Adv Nurs. 2020 Dec;76(12):3609-3622. doi: 10.1111/jan.14548. Epub 2020 Sep 30.

  PMID: 32996629 BACKGROUND

• Liu W, Tripp-Reimer T, Williams K, Shaw C. Facilitators and barriers to optimizing eating performance among cognitively impaired older adults: A qualitative study of nursing assistants' perspectives. Dementia (London). 2020 Aug;19(6):2090-2113. doi: 10.1177/1471301218815053. Epub 2018 Nov 27.

  PMID: 30482090 BACKGROUND

• Miller N, Noble E, Jones D, Burn D. Hard to swallow: dysphagia in Parkinson's disease. Age Ageing. 2006 Nov;35(6):614-8. doi: 10.1093/ageing/afl105.

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• Perry SE, Borders JC, Dakin AE, Troche MS. Characterizing Quality of Life in Caregivers of People with Parkinson's Disease and Dysphagia. Dysphagia. 2022 Jun;37(3):523-532. doi: 10.1007/s00455-021-10299-z. Epub 2021 May 15.

  PMID: 33991229 BACKGROUND

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• Pomey MP, Flora L, Karazivan P, Dumez V, Lebel P, Vanier MC, Debarges B, Clavel N, Jouet E. [The Montreal model: the challenges of a partnership relationship between patients and healthcare professionals]. Sante Publique. 2015 Jan-Feb;27(1 Suppl):S41-50. French.

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• Schindler A, Pizzorni N, Cereda E, Cosentino G, Avenali M, Montomoli C, Abbruzzese G, Antonini A, Barbiera F, Benazzo M, Benarroch E, Bertino G, Clave P, Cortelli P, Eleopra R, Ferrari C, Hamdy S, Huckabee ML, Lopiano L, Marchese-Ragona R, Masiero S, Michou E, Occhini A, Pacchetti C, Pfeiffer RF, Restivo DA, Rondanelli M, Ruoppolo G, Sandrini G, Schapira A, Stocchi F, Tolosa E, Valentino F, Zamboni M, Zangaglia R, Zappia M, Tassorelli C, Alfonsi E. Consensus on the treatment of dysphagia in Parkinson's disease. J Neurol Sci. 2021 Nov 15;430:120008. doi: 10.1016/j.jns.2021.120008. Epub 2021 Sep 27.

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• Shune SE, Namasivayam-MacDonald AM. Swallowing Impairments Increase Emotional Burden in Spousal Caregivers of Older Adults. J Appl Gerontol. 2020 Feb;39(2):172-180. doi: 10.1177/0733464818821787. Epub 2019 Jan 9.

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  PMID: 26970760 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Margherita FABBRI

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 12, 2023
• Study Start: February 1, 2024
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)