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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02825927
Other study ID # 2013/100/3
Secondary ID
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
Health authority
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

Study Design


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
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