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

Quality of Life Clinical Trial

— SOFIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825927
• Other study ID #: 2013/100/3
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: December 15, 2017
• Start date: October 2013
• Est. completion date: November 2017

Study information

• Verified date: June 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease
• Dysphagia
• Quality of Life
• Swallowing Disorders

Intervention

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

Locations

Country	Name	City	State
Sweden	Region Örebro län	Örebro

Sponsors (6)

Lead Sponsor	Collaborator
Umeå University	Dalarna University, Karlstad University, Örebro University, Sweden, Region Gävleborg, Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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