Understanding mealtime assistance for people with Parkinson's disease
Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake
This study looks at how caregivers help people with Parkinson's disease who have trouble swallowing during meals to see what works best for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse, Haute-Garonne) |
| Trial ID | NCT05898139 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe the strategies used by caregivers to assist individuals with Parkinson's disease who have swallowing difficulties during meals. It focuses on verbal and non-verbal communication methods, as well as the environmental context that influences mealtime experiences. The study involves observing a meal and conducting interviews with both the patient and caregiver to gather insights on their interactions and challenges. The findings will be validated through self-confrontation techniques, where participants reflect on recorded meal excerpts.
Who should consider this trial
Good fit: Ideal candidates include individuals with typical or atypical Parkinsonian syndrome who experience swallowing disorders and require assistance during meals.
Not a fit: Patients who are cognitively impaired to the extent that they cannot answer simple questions or those who are exclusively fed through enteral nutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mealtime safety and enjoyment for patients with Parkinson's disease and their caregivers.
How similar studies have performed: While there is existing literature on mealtime assistance for dysphagia, this specific observational approach focusing on caregiver strategies in Parkinson's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse, Haute-Garonne
- University Hospital, Parkinson center — Toulouse, Haute-Garonne, France (Recruiting)
Study contacts
- Principal investigator: Margherita FABBRI — CHU Toulouse
- Study coordinator: Margherita FABBRI, Dr.
- Email: fabbri.m@chu-toulouse.fr
- Phone: 05 61 77 25 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.