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

Primary Purpose

Dysphagia, Deglutition Disorders, Swallowing Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Oral screen
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Oral screen, Intervention, Oral Health, Food Intake, Quality of life, Elderly, Short-term care facilities

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region Örebro län

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Intensive training with oral screen for 5 weeks.

The control group is not offered any intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Oral Health
Change in oral health status measured by the Revised Oral Assessment Guide (ROAG). Comparisons between intervention-and control group will be made.
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.
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.
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.

Full Information

First Posted
July 4, 2016
Last Updated
December 15, 2017
Sponsor
Umeå University
Collaborators
Region Örebro County, Karlstad University, Region Gävleborg, Dalarna University, Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02825927
Brief Title
Swallowing Function, Oral Health, and Food Intake in Old Age
Acronym
SOFIA
Official Title
Swallowing Function, Oral Health, and Food Intake in Old Age
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Region Örebro County, Karlstad University, Region Gävleborg, Dalarna University, Örebro University, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Deglutition Disorders, Swallowing Disorders, Quality of Life
Keywords
Dysphagia, Oral screen, Intervention, Oral Health, Food Intake, Quality of life, Elderly, Short-term care facilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intensive training with oral screen for 5 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group is not offered any intervention.
Intervention Type
Other
Intervention Name(s)
Oral screen
Intervention Description
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 Outcome Measure Information:
Title
Swallowing function
Description
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.
Time Frame
Baseline, 5 weeks and 6 months post-intervention
Secondary Outcome Measure Information:
Title
Quality of life related to swallowing
Description
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.
Time Frame
Baseline, 5 weeks and 6 months post-intervention
Title
Oral Health
Description
Change in oral health status measured by the Revised Oral Assessment Guide (ROAG). Comparisons between intervention-and control group will be made.
Time Frame
Baseline, 5 weeks and 6 months post-intervention
Title
Food Intake
Description
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.
Time Frame
Baseline, 5 weeks and 6 months post-intervention
Title
Activity of daily living
Description
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.
Time Frame
Baseline, 5 weeks and 6 months post-intervention
Title
Quality of life related to oral health
Description
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.
Time Frame
Baseline, 5 weeks and 6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Carlsson, PhD, Nurse
Organizational Affiliation
Region Örebro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Örebro län
City
Örebro
ZIP/Postal Code
701 11
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31062842
Citation
Hagglund P, Hagg M, Wester P, Levring Jaghagen E. Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care-a cluster randomised, controlled trial. Age Ageing. 2019 Jul 1;48(4):533-540. doi: 10.1093/ageing/afz042.
Results Reference
derived
PubMed Identifier
29663160
Citation
Hagglund P, Falt A, Hagg M, Wester P, Levring Jaghagen E. Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study. Aging Clin Exp Res. 2019 Jan;31(1):85-94. doi: 10.1007/s40520-018-0944-7. Epub 2018 Apr 16.
Results Reference
derived
PubMed Identifier
28335729
Citation
Hagglund P, Olai L, Stahlnacke K, Persenius M, Hagg M, Andersson M, Koistinen S, Carlsson E. Study protocol for the SOFIA project: Swallowing function, Oral health, and Food Intake in old Age: a descriptive study with a cluster randomized trial. BMC Geriatr. 2017 Mar 23;17(1):78. doi: 10.1186/s12877-017-0466-8.
Results Reference
derived

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

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