Clinical trial NCT05898139: Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake
Official title: Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Deglutition Disorders
Keywords: Dysphagia
Assistance feeding
Parkinson disease
Caregivers
Mealtime
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with typical or atypical parkinsonian syndrome and their caregiver

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

Detailed description: It is described in the literature that being helped for the meal disrupts the pre-oral phase in the visual and proprioceptive afferences received by the sick person to prepare neurologically the other phases of swallowing. In cases of dysphagia, regardless of the cause, the need for food assistance is correlated with higher mortality and an increased risk of pneumonia. Thus, whether at home or in an establishment, human help is often put in place to facilitate the time of the meal, make it more effective (limitation of the duration of the meal, maximization of the nutritional amounts ingested) and safe (prevention of the occurrence of wrong driving). Our hypothesis is that representations about food and aid at meal times, as well as the attitudes of both the helper and the helped, are factors influencing the realization of an adapted human aid when eating a meal in a dependent person. An observation of a meal during a hospitalization and an interview with the sick person and his caregiver are 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. A report of the thematic elements identified during the interviews will be proposed for validation by the dyad. This visit can be made during a scheduled appointment in the hospital, by videoconference or at home if the participants do not have access to a videoconference system.

Eligibility criteria: For patients:

Inclusion Criteria:

* 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.
* Free, informed, written and signed consent by participant and investigator (no later than the day of inclusion and prior to any review required by the research)

Exclusion Criteria:

* 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:

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient who refuses to be filmed
* Protected patient: under guardianship, trusteeship or other legal protection, deprived of freedom by judicial or administrative decision

Primary outcomes:
measure: Strategies description
timeFrame: 13 months
Secondary outcomes:
measure: Description of the perception of meal time, patient's point of view
timeFrame: 13 months
measure: Description of the perception of meal time, helper's point of view
timeFrame: 13 months
measure: Description of quality of life related to meal time
timeFrame: 13 months
measure: Identification of specific needs for educational programmes
timeFrame: 13 months
measure: Description of strategies put in place during meal time
timeFrame: 13 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital, Parkinson center
state: Haute-Garonne
Study officials:
affiliation: CHU Toulouse
name: Margherita FABBRI
role: PRINCIPAL_INVESTIGATOR
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