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

Parkinson Disease Clinical Trial

— AideAlimPark  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898139
• Other study ID #: RC31/22/0527
• Secondary ID: 2023-A00393-42
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: Margherita FABBRI, Dr.
• Phone: 05 61 77 25 35
• Email: fabbri.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale or collection in the medical record

• Person dependent on food (according to MDS-UPDRS - food tasks item, part II, 2.4, need help with all food tasks)

• Day or traditional hospitalization in the neurology department, including a meal.

• 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

Related Conditions & MeSH terms

• Deglutition Disorders
• Parkinson Disease

Locations

Country	Name	City	State
France	University Hospital, Parkinson center	Toulouse	Haute-Garonne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (17)

Batchelor-Murphy MK, McConnell ES, Amella EJ, Anderson RA, Bales CW, Silva S, Barnes A, Beck C, Colon-Emeric CS. Experimental Comparison of Efficacy for Three Handfeeding Techniques in Dementia. J Am Geriatr Soc. 2017 Apr;65(4):e89-e94. doi: 10.1111/jgs.14728. Epub 2017 Feb 6. — View Citation

Cosentino G, Avenali M, Schindler A, Pizzorni N, Montomoli C, Abbruzzese G, Antonini A, Barbiera F, Benazzo M, Benarroch EE, Bertino G, Cereda E, 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 AHV, Stocchi F, Tolosa E, Valentino F, Zamboni M, Zangaglia R, Zappia M, Tassorelli C, Alfonsi E. A multinational consensus on dysphagia in Parkinson's disease: screening, diagnosis and prognostic value. J Neurol. 2022 Mar;269(3):1335-1352. doi: 10.1007/s00415-021-10739-8. Epub 2021 Aug 21. — View Citation

Fabbri M, Coelho M, Abreu D, Guedes LC, Rosa MM, Godinho C, Cardoso R, Guimaraes I, Antonini A, Zibetti M, Lopiano L, Ferreira JJ. Dysphagia predicts poor outcome in late-stage Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:73-81. doi: 10.1016/j.parkreldis.2019.02.043. Epub 2019 Mar 2. — View Citation

Flora L, Berkesse A, Payot A, Dumez V, Karazivan P. [THE APPLICATION OF AN INTEGRATED MODEL OF PARTNERSHIP- PATIENT IN THE PROFESSIONALS OF THE HEALTH TRAINING: TOWARDS NEW ONE HUMANIST PARADIGM AND ETHICS OF CO-CONSTRUCTION KNOWLEDGES IN HEALTH]. J Int Bioethique Ethique Sci. 2016 Mar-Jun;27(1-2):59-72, 228. French. — View Citation

Howells SR, Cornwell PL, Ward EC, Kuipers P. Living with Dysphagia in the Community: Caregivers "do whatever it takes.". Dysphagia. 2021 Feb;36(1):108-119. doi: 10.1007/s00455-020-10117-y. Epub 2020 Apr 24. — View Citation

Leow LP, Huckabee ML, Anderson T, Beckert L. The impact of dysphagia on quality of life in ageing and Parkinson's disease as measured by the swallowing quality of life (SWAL-QOL) questionnaire. Dysphagia. 2010 Sep;25(3):216-20. doi: 10.1007/s00455-009-9245-9. Epub 2009 Aug 13. — View Citation

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. — View Citation

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. — View Citation

Liu W, Williams K, Batchelor-Murphy M, Perkhounkova Y, Hein M. Eating performance in relation to intake of solid and liquid food in nursing home residents with dementia: A secondary behavioral analysis of mealtime videos. Int J Nurs Stud. 2019 Aug;96:18-26. doi: 10.1016/j.ijnurstu.2018.12.010. Epub 2019 Jan 3. — View Citation

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. — View Citation

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. — View Citation

Pflug C, Bihler M, Emich K, Niessen A, Nienstedt JC, Flugel T, Koseki JC, Plaetke R, Hidding U, Gerloff C, Buhmann C. Critical Dysphagia is Common in Parkinson Disease and Occurs Even in Early Stages: A Prospective Cohort Study. Dysphagia. 2018 Feb;33(1):41-50. doi: 10.1007/s00455-017-9831-1. Epub 2017 Aug 21. — View Citation

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. — View Citation

Pu D, Yiu EML, Chan KMK. Factors associated with signs of aspiration in older adults: A prospective study. Geriatr Nurs. 2020 Sep-Oct;41(5):635-640. doi: 10.1016/j.gerinurse.2020.03.019. Epub 2020 May 10. — View Citation

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. — View Citation

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. — View Citation

Takizawa C, Gemmell E, Kenworthy J, Speyer R. A Systematic Review of the Prevalence of Oropharyngeal Dysphagia in Stroke, Parkinson's Disease, Alzheimer's Disease, Head Injury, and Pneumonia. Dysphagia. 2016 Jun;31(3):434-41. doi: 10.1007/s00455-016-9695-9. Epub 2016 Mar 12. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Description of the perception of meal time, patient's point of view	Thematic analysis of the perception of meal timing, diet, meal assistance for the sick person.	13 months
Secondary	Description of the perception of meal time, helper's point of view	Thematic analysis of the perception of meal timing, diet, meal assistance for the caregiver	13 months
Secondary	Description of quality of life related to meal time	Identify factors that contribute to and detract from meal-related quality of life satisfaction.	13 months
Secondary	Identification of specific needs for educational programmes	Identify the needs of carers to adapt or place specific educational programmes	13 months
Secondary	Description of strategies put in place during meal time	Overview of the strategies put in place to promote a compromise between nutritional, safety and hedonic objectives	13 months