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

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ClinicalTrials.gov Identifier: NCT02825927
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
Region Örebro County
Karlstad University
Region Gävleborg
Dalarna University
Örebro University, Sweden
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dysphagia Deglutition Disorders Swallowing Disorders Quality of Life Other: Oral screen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swallowing Function, Oral Health, and Food Intake in Old Age
Study Start Date : October 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Intervention group
Intensive training with oral screen for 5 weeks.
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.

No Intervention: Control group
The control group is not offered any intervention.



Primary Outcome Measures :
  1. Swallowing function [ Time Frame: 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 :
  1. Quality of life related to swallowing [ Time Frame: 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.

  2. Oral Health [ Time Frame: 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.

  3. Food Intake [ Time Frame: 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.

  4. Activity of daily living [ Time Frame: 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.

  5. Quality of life related to oral health [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825927


Locations
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Sweden
Region Örebro län
Örebro, Sweden, 701 11
Sponsors and Collaborators
Umeå University
Region Örebro County
Karlstad University
Region Gävleborg
Dalarna University
Örebro University, Sweden
Investigators
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Principal Investigator: Eva Carlsson, PhD, Nurse Region Örebro
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT02825927    
Other Study ID Numbers: 2013/100/3
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Umeå University:
Dysphagia
Oral screen
Intervention
Oral Health
Food Intake
Quality of life
Elderly
Short-term care facilities
Additional relevant MeSH terms:
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Deglutition Disorders
Disease
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases