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Completed

NCT Number: NCT02825927

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

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Quality of Life Swallowing Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Örebro län

Örebro, 701 11, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral screen

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Dalarna University
  • Karlstad University
  • Region Gävleborg
  • Region Örebro County
  • Örebro University, Sweden

Registry information

Acronym: SOFIA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2016
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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