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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02825927
Acronym
SOFIA
Enrollment
116
Registered
2016-07-07
Start date
2013-10-31
Completion date
2017-11-30
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders, Dysphagia, Quality of Life, Swallowing Disorders

Keywords

Dysphagia, Oral screen, Intervention, Oral Health, Food Intake, Quality of life, Elderly, Short-term care facilities

Brief summary

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

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.

Interventions

The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.

Sponsors

Region Örebro County
CollaboratorOTHER
Karlstad University
CollaboratorOTHER
Region Gävleborg
CollaboratorOTHER
Dalarna University
CollaboratorOTHER
Örebro University, Sweden
CollaboratorOTHER
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Swallowing functionBaseline, 5 weeks and 6 months post-interventionChange in swallowing function measured by the Swallowing Capacity Test (SCT) combined with a teaspoon test. Comparisons between intervention-and control group will be made.

Secondary

MeasureTime frameDescription
Quality of life related to swallowingBaseline, 5 weeks and 6 months post-interventionChange 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.
Oral HealthBaseline, 5 weeks and 6 months post-interventionChange in oral health status measured by the Revised Oral Assessment Guide (ROAG). Comparisons between intervention-and control group will be made.
Food IntakeBaseline, 5 weeks and 6 months post-interventionChange 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.
Activity of daily livingBaseline, 5 weeks and 6 months post-interventionChange 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.
Quality of life related to oral healthBaseline, 5 weeks and 6 months post-interventionChange 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026