Design of a Food Preference Assessment Tool for Older Patients in Geriatrics units_DYSPHAGING-PREFERENCES
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorHospices Civils de Lyon
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient unable to complete the questionnaire.
Patient unable to eat orally
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
ADAPTATION
Other interventionFor 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
test-retest reliability
Other interventionFor 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)
Cross-sectional study
Other interventionFor 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)
Treatment groups
209 Participants
are divided into 3 treatment groupsGroup A: Step 1: adaptation of the CFTQP to a geriatric population1 intervention
Group B: Step 2: test-retest reliability analysis of the device1 intervention
Group C: Step 3: cross-sectional study1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 to 3 days2
Assessing the reproducibility of the food preference index
Evaluation of the reproducibility of the preference indices obtained between the two questionnaires (intraclass correlation coefficient).
Time frame
7 to 10 days3
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.
Time frame
7 to 10 daysSponsors and contacts
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Source ClinicalTrials.gov