Clinical trial NCT02825927: Swallowing Function, Oral Health, and Food Intake in Old Age
Official title: Swallowing Function, Oral Health, and Food Intake in Old Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Örebro County
name: Karlstad University
name: Region Gävleborg
name: Dalarna University
name: Örebro University, Sweden
First posted: 2016-07-07
Enrollment: 116
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Swallowing function
timeFrame: Baseline, 5 weeks and 6 months post-intervention
Secondary outcomes:
measure: Quality of life related to swallowing
timeFrame: Baseline, 5 weeks and 6 months post-intervention
measure: Oral Health
timeFrame: Baseline, 5 weeks and 6 months post-intervention
measure: Food Intake
timeFrame: Baseline, 5 weeks and 6 months post-intervention
measure: Activity of daily living
timeFrame: Baseline, 5 weeks and 6 months post-intervention
measure: Quality of life related to oral health
timeFrame: Baseline, 5 weeks and 6 months post-intervention
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Region Örebro län
Study officials:
affiliation: Region Örebro
name: Eva Carlsson, PhD, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.