Swallowing Function, Oral Health, and Food Intake in Old Age
NCT ID: NCT02825927
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2013-10-31
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
Intensive training with oral screen for 5 weeks.
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.
Control group
The control group is not offered any intervention.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Admitted to short-term care facility ≥ 3 days
* Included in the overall project SOFIA and with a swallowing capacity \<10ml/sec
Exclusion Criteria
65 Years
ALL
No
Sponsors
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Region Örebro County
OTHER
Karlstad University
OTHER
Region Gävleborg
OTHER
Dalarna University
OTHER
Örebro University, Sweden
OTHER
Umeå University
OTHER
Responsible Party
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Principal Investigators
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Eva Carlsson, PhD, Nurse
Role: PRINCIPAL_INVESTIGATOR
Region Örebro
Locations
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Region Örebro län
Örebro, , Sweden
Countries
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References
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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.
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.
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.
Other Identifiers
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2013/100/3
Identifier Type: -
Identifier Source: org_study_id