Design of a Food Preference Assessment Tool for Older Patients in Geriatrics units_DYSPHAGING-PREFERENCES

NCT07205354 | Recruiting

• 1 other identifier: 69HCL25_0022
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 3

Brief Summary

Swallowing disorders - or oral dysphagia (OD) - are identified as a cause of malnutrition. They gradually lead patients to withdraw certain foods from their diet, leading to progressive dietary imbalances, or increased cardiovascular risks. Two European societies (the European Society for Swallowing Disorders and the European Union Geriatric Medicine Society) have defined recommendations that include raising awareness of OD, the use of screening scores, preventive measures, diagnostic standardization and interventions implemented (re-education, adaptation of textures). We recently reported the results of the DYSPHAGING Pilot Study that validated the feasibility of a standardized care path including a systematic screening of OD and the implementation of preventive measures in geriatric wards. DYSPHAGING Preferences is a three-step research program designed to develop (step 1) a specific device to evaluate food preferences in geriatric populations, adapted from the CFTPQ, evaluate its test-retest reliability (step 2), and perform a cross-sectional study to explore individual differences within the older population depending on their geriatric characteristics and, among them, on the presence or not of OD (step 3).

Conditions

Swallowing Disorder; Eating Habits; Hospitalisation in Geriatrics

Keywords

geriatric; denutrition; Dysphagia

Outcome Measures

Primary Outcomes (3)

• Adapting a tool for assessing food preferences in patients over 70 years of age hospitalised in geriatric wards, based on a paediatric tool for assessing food texture preferences.

  Proportion of foods recognised among those offered (a food will be retained if the proportion is greater than 0.8). The tool will be considered suitable when each category contains 8 foods of interest and 8 opposing foods, i.e. 16 foods recognised by at least 80% of the patients tested.

  1 to 3 days

• Assessing the reproducibility of the food preference index

  Evaluation of the reproducibility of the preference indices obtained between the two questionnaires (intraclass correlation coefficient).

  7 to 10 days

• Assessing the association between dysphagia and food preferences

  The presence of dysphagia disorders will be defined by a score of ≥ 3 on the EAT-10 questionnaire.

  7 to 10 days

Study Arms (3)

Step 1: adaptation of the CFTQP to a geriatric population

This step was designed to assess the recognition of pre-selected food pictures in the older population. A group of at least 35 patients who have completed the entire questionnaire is expected.

Other: ADAPTATION

Step 2: test-retest reliability analysis of the device

This step was designed to ensure individual reproductibility of the device. A group of at least 35 patients who have completed the entire questionnaire is expected.

Other: test-retest reliability

Step 3: cross-sectional study

A group of at least 209 patients (including 35 patients of step 2) is expected

Other: Cross-sectional study

Interventions

ADAPTATION OTHER

For each patient (set of at least 35 patients), the assessor will ask the patient: * Have you ever eaten this food? YES or NO * Does the photo match the description? YES or NO * 20 photos of foods per category are provided (10 + 10) * If the foods tested are recognised (YES answer to both questions) by more than 80% of the study population, they will be retained. * The 16 foods (8+8) with the highest recognition rates will be retained. * If fewer than 16 foods (8+8) per category are recognised, the list will be modified by retaining the recognised foods and adding new foods to obtain the 'modified list'. 2- If the criteria are not validated, a modified list is resubmitted to a new sample of 35 patients until the objectives are validated and a suitable questionnaire is obtained. Obtaining an ADAPTED DYSPHAGING PREFERENCES QUESTIONNAIRE is a prerequisite for moving on to the test-retest reliability phase

Step 1: adaptation of the CFTQP to a geriatric population

test-retest reliability OTHER

For each patient (new set of 35 patients) * the DYSPHAGING preferences questionnaire (including previously adapted pictures) will be assessed and preference indexes will be determined. * Within 3-7 days, each patient will be asked for the forced choice in the second step of phase 2. A new preference index will be determined using the first recognition and the second forced choices answers. * Test-retest reliability will be assessed by determination of an intra-class correlation coefficient between the two indexes obtained for each patient tested. (Good test-retest reliability will be considered with an intra-class correlation coefficient upper than 0,75 in each category and will be expected in at least 4 of the 6 tested categories to perform the cross-sectional study (phase 3)

Step 2: test-retest reliability analysis of the device

Cross-sectional study OTHER

For each patient (new set of 174 patients) * the DYSPHAGING preferences questionnaire (including previously adapted pictures) will be assessed and preference indexes will be determined. * In addition, for each patient, collection of geriatric covariates obtained in routine care will be performed for analyses ( demographic characteristics (age, sex, functionality according to the activity of daily living (ADL)8 and instrumental ADL6 scores), local and factors affecting taste, mastication or dietary patterns (dental condition/dental apparatus, alcoholism, smoking, food allergies, comorbidities, treatments), nutritional status (ideal and current weight/height/BMI, albumin, pre-albumin, Vitamins B12, B9, D), comedications (as described as according to the galenic form and drug class prescribed) and swallowing disorders (EAT-10 score with cut-off of 3)

Step 3: cross-sectional study

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include older patient identified either during their admission (in acute care and rehabilitation units) or during systematic assessments in long-term care units. Patients likely to participate in the study will be identified within the geriatric ward as part of their regular medical follow-up. Patients will be informed of the existence of the protocol by an investigating physician or a member of the local healthcare team. A non-opposition will be recorded.

You may qualify if:

• Patient aged over 70
• Patient hospitalised in the healthcare sector (CSG, SMR)
• Patient or patient under guardianship informed of the study and having expressed no objection to participating in the study
• Patient under guardianship whose guardian has been informed of the study and has expressed no objection to the patient's participation in the study.

You may not qualify if:

• Patient unable to complete the questionnaire.
• Patient unable to eat orally

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hopital Pierre GARRAUD Unité de Soins Médicaux et de Réadaptation

Lyon, 69005, France

NOT YET RECRUITING

Groupement hospitalier Sud Court Séjour de Gériatrie

Pierre-Bénite, 69310, France

RECRUITING

Groupement hospitalier Sud Unité de Soins Médicaux et de Réadaptation

Pierre-Bénite, 69310, France

NOT YET RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Feeding Behavior

Interventions

Acclimatization; Reproducibility of Results; Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Studies; Epidemiologic Study Characteristics

Central Study Contacts

Marion MERDINIAN, Dr

CONTACT

478861590; marion.merdinian@chu-lyon.fr

Nicolas MASSE-DERAGON

CONTACT

661741357; nicolas.masse@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 3, 2025
• Study Start: October 10, 2025
• Primary Completion: January 10, 2026
• Study Completion (Estimated): February 10, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (3)