Swallowing Function, Oral Health, and Food Intake in Old Age

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.

Detailed Description
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The present study aims to investigate the effects on swallowing function of a specific rehabilitation program with oral screen in the elderly population included. The present study is a part of an on-going cross-sectional, descriptive project called SOFIA where approximately 400 elderly individuals, admitted to short-term care (from the five regions/county Dalarna, Gävleborg, Örebro, Värmland and Västerbotten in Sweden), will be included. The purpose of the overall project is to gain a broader understanding of aspects of dysphagia, eating, oral health, and quality of life and care among elderly people in short-term care facilities. In the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity <10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. The participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. A control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status. Cluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. Participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at. The investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity.

Official Title
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Swallowing Function, Oral Health, and Food Intake in Old Age

Conditions
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Dysphagia, Deglutition Disorders, Swallowing Disorders, Quality of Life

Intervention / Treatment
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* Other: Oral screen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 Admitted to short-term care facility ≥ 3 days Included in the overall project SOFIA and with a swallowing capacity <10ml/sec Exclusion Criteria: Incapable of making decisions

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intensive training with oral screen for 5 weeks. | Other: Oral screen<br>* The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.<br>|
| No Intervention: Control group<br>The control group is not offered any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing function | Change in swallowing function measured by the Swallowing Capacity Test (SCT) combined with a teaspoon test. Comparisons between intervention-and control group will be made. | Baseline, 5 weeks and 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life related to swallowing | Change in quality of life related to swallowing measured by the Swallowing Quality of Life Questionnaire (SWAL-QOL). Comparisons between intervention-and control group will be made. | Baseline, 5 weeks and 6 months post-intervention | 
| Oral Health | Change in oral health status measured by the Revised Oral Assessment Guide (ROAG). Comparisons between intervention-and control group will be made. | Baseline, 5 weeks and 6 months post-intervention | 
| Food Intake | Change in nutritional status measured by the Minimal Eating Observation and Nutrition Test Version II ( MEONF-II). Comparisons between intervention-and control group will be made. | Baseline, 5 weeks and 6 months post-intervention | 
| Activity of daily living | Change in status regarding activity of daily living measured by the Katz Index of Independence in Activities of Daily Living (Katz ADL-index). Comparisons between intervention-and control group will be made. | Baseline, 5 weeks and 6 months post-intervention | 
| Quality of life related to oral health | Change in quality of life related to oral health measured by the Oral Health Impact Profile (OHIP-14). Comparisons between intervention-and control group will be made. | Baseline, 5 weeks and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Oral screen, Intervention, Oral Health, Food Intake, Quality of life, Elderly, Short-term care facilities