Swallowing Function, Oral Health, and Food Intake in Old Age (SOFIA)

Umeå University

Status: Completed

Conditions: Dysphagia; Quality of Life; Swallowing Disorders; Deglutition Disorders

Treatments: Other: Oral screen

Study type: Interventional

Funder types: Other

Identifiers

NCT02825927

2013/100/3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intensive training with oral screen for 5 weeks.

Treatment:

Other: Oral screen

Control group

No Intervention group

Description:

The control group is not offered any intervention.