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

Not Applicable

Completed

• Conditions: Dysphagia; Deglutition Disorders; Swallowing Disorders; Quality of Life
• Interventions: Other: Oral screen

• Registration Number: NCT02825927
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2016-06
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-07
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral screen	Intensive training with oral screen for 5 weeks.

Primary Outcome Measures

Name	Time	Method
Swallowing function	Baseline, 5 weeks and 6 months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life related to swallowing	Baseline, 5 weeks and 6 months post-intervention	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.
Oral Health	Baseline, 5 weeks and 6 months post-intervention	Change in oral health status measured by the Revised Oral Assessment Guide (ROAG). Comparisons between intervention-and control group will be made.
Food Intake	Baseline, 5 weeks and 6 months post-intervention	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.
Activity of daily living	Baseline, 5 weeks and 6 months post-intervention	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.
Quality of life related to oral health	Baseline, 5 weeks and 6 months post-intervention	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.

Trial Locations

Locations (1)

Region Örebro län; 🇸🇪 Örebro, Sweden